Deliverable D.4.7 "Information collation -Report on collation of existing information and links on where to seek information and guidance" describes the methodology and tools used for collecting and selecting information regarding gene and cell therapy development. It focuses on how the information is

Table of Contents

Objectives of the deliverable

The overall objective of WP4 is to develop an information hub for the research and regulatory communities to facilitate their access to high-quality information on the practical steps needed for cell and gene-based therapy development.

Deliverable D.4.7 "Information collation" constitutes the root of WP4. This deliverable reports on the methodology for collecting and selecting (i.e. collation) of information regarding the ATMP product development pathway and therefore contributes to the content of the EuroGCT website (WP4 Tasks 1 to 3 in GA); the mapping of actors and networks active in the field of gene and cell therapy (WP4 Task 4 in GA); and the identification of existing procedures, times, or spaces for engagement with regulators (WP4 Task 5). To meet these WP4 objectives, relevant and reliable information must be identified and made accessible on the EuroGCT website.

The information needed to achieve these objectives is extensive, various and scattered. The methodology on the collection and selection needs to be clear and detailed. Hence, Deliverable D.4.7 "Information collation" presents how such information is being collected by describing the methodological approach and the tools we used. The information and links collated at the time of submission of this deliverable are provided as appendices to D4.7. We note that the highly specialist nature of the information collated in WP4 means that the methodology for identification and selection of information and links relevant to this WP requires a specific approach separate from the approach described in D1.1 and D1.3, which describe collation of information suitable for dissemination to public audiences.

Methodological approach

Several complementary approaches have been used to collect existing information on cell and gene therapy to meet WP4 objectives: a) Scientific and legal research on existing gene and cell therapy general information

We started by conducting a scientific and legal watch through searching for gene and cell therapy information on institutional websites (including the European Commission, national agencies and the European Medicines Agency), and scientific/societal sources (such as learned societies, patient organisations, research infrastructures, clinical trials databases, and more organisations active in the field). Please see D4.7 Annexe 1 for the detailed list of such websites.

We note that information and guidance for patients seeking for clinical trials and available products is partially addressed in D3.2 Decision-making Resources and D3.9 Initial fact sheets and resources (examples of resources include 'Do you have a decision to make around your own healthcare, or the healthcare of a loved one?', 'What conditions can currently be treated using gene and cell therapy?', 'What is the clinical trials process?', and 'What are unproven therapies?'). It is beyond the scope of our project to be a 'gatekeeper' which endorses specific treatments and clinics, and indeed it could compromise the project's credibility were we to do so (this issue has been discussed by the International Society for Stem Cell Research, which also reached this conclusion). However, the resources presented both in WP4 (Research Pathways information hub) and WP3 (especially a subset reported in Ds 3.2 and 3.9) will help facilitate informed conversations between patients and healthcare professionals, as well as directing them to relevant information.

b) Legal watch for European Union legislation on gene and cell therapy

We then set up a specific legal watch complementary to the above general scientific and legal watch to search for all binding EU texts that apply to ATMP. Because EU texts are centralised in the Eur-Lex website, we mainly focused our research here and then combined with those on the EU institutions' websites. For the full list of applicable EU binding texts, please see Annexe 2.a. The the links collated in this Annexe have been published on the website within each published EuroGCT full entries inside 'Key Research Pathways' (https://www.eurogct.org/research-pathways/key-research-pathways). See all 'European Union Legislation' sections within. An example can be directly accessed here: https://www.eurogct.org/research-pathways/commercialisation/market-accessatmps/standard-marketing-authorisation-pathway#para-414. More examples can be found within the 'Public Involvement and Data' section and the sub-entries within 'Commercialisation / Market Access for ATMPs'. A list of published full entries can be found in D4.1 Annexe 1.

c) Research on information available on applicable guidelines

In addition to the binding legal framework, ATMP development is subject to many guidelines and guidance that need to be identified and collated. We have researched the information available on applicable guidelines, especially on the EMA website, the European Commission website and ICH. For the full list of applicable European guidelines, please see D4.7 Annexe 2.b. The the links collated in this Annexe have been published on the website within each published EuroGCT resources in 'Key Research Pathways', and all 'European Union Guidance' sections within. An example can be accessed at: https://www.eurogct.org/research-pathways/commercialisation/market-accessatmps/standard-marketing-authorisation-pathway#para-415. A list of published full entries can be found in D4.1 Annexe 1.

d) Participation in conferences and workshops to collect information

Attending selected scientific conferences and workshops allows us to collect up-to-date information, and to identify the main issues in the field. We have created an evolutive list of events to attend. For the full list of attended conferences, workshops and seminars, please see D4.7 Annexe 2.c.

e) Collecting information from EuroGCT partners

Two approaches have been used to collect relevant information from EuroGCT partners. First, partners can send us relevant information via emails. Second, we have created ELSI Working Groups in accordance with the Research Pathways draft tree (See D4.8). Partners can choose to join and contribute to one or more ELSI Working Groups base on their expertise and interest.

f) Creation of ELSI Bibliography on gene and cell therapy

Literature regarding ELSI of gene and cell therapy, especially ATMP, tends to be scattered and not easily accessible. We have established a specific methodology to address this--we listed the main Social and Human Sciences databases and to search within by key words "ATMP" or "gene and cell therapy" and "European Union". This work is divided in two phases: phase one covers what we consider to be the most used Social and Human Sciences databases, especially in law; phase two covers complementary Social and Human Sciences databases (D4.7 Annexe 2.d.). A template of research record for bibliography has been established (D4.7 Annexe 3.a.). The the links collated in these Annexes have been published on the website within each published EuroGCT resources in 'Key Research Pathways', and all 'Relevant literature' section within. An example can be accessed here: https://www.eurogct.org/research-pathways/commercialisation/market-accessatmps/standard-marketing-authorisation-pathway#para-1393. A list of published full entries can be found in D4.1 Annexe 1.

g) Creation of templates

For dissemination of the information and resources collated for the Research and Regulatory communities (WP4), EuroGCT will provide direct links to relevant scientific articles, ELSI and legal literature whenever possible. To enhance accessibility, EuroGCT also aims to provide lay summaries, accessible to various non-specialist stakeholders. This will be done by contacting the authors or the development of lay summaries written by the ELSI Network of

h) ELSI Network of Expertise

The ELSI network of expertise is constituted of EuroGCT partners and experts external to EuroGCT who have knowledge, expertise and research interest on the ELSI aspects of gene and cell therapy. These external members have been recruited through EuroGCT partners' own networks, especially those of partner 2. They are also being identified through the ELSI bibliography being developed as social and human sciences authors who have published on the ELSI aspects of gene and cell therapy in recognised social and human sciences reviews. See D4.7 Annexe 4 for the list of social and human sciences research centres that have been identified.

Summary of activities and outputs

Section 3 summarises our results to date regarding identification and collection of information using the methodological approaches described in 2 above, and also outlines our ongoing work.

a) Selection of a common terminology for use throughout EuroGCT

In addition to the general objectives of information collation (see 1), the scientific & legal watch described in 2 above has contributed substantially to ongoing work focussed on defining a common vocabulary for EuroGCT. Use of a precise, defined vocabulary is necessary considering the multi-disciplinary nature of the consortium including the core ELSI team, as precise terminology helps both specialist and non-specialist audiences (including the general public) understand and navigate information provide both through the project and outside. WP4 work in this area has led to the choice of project key terms such as "development pathway", "regulation", "ATMP", "medicines" but not "drugs" as general terms. The relevant key words and the works on definitions are also being integrated in the general overviews of each sub-entry in the Research Pathways section (see D4.8). For instance, the general overviews include a "Definitions" section, which highlight and clarify which words are used by which type of stakeholders considering this stage of the development pathway.

The list of the websites that have been consulted so far during the scientific & legal watch and research for general information are listed in full in D4.7 Annexe 1.

b) Collation of information on European Union legislation on gene and cell therapy

The legal watch and research for the applicable European Union legislation on gene and cell therapy described in 2 above has led to the development of a 'binding texts' list (see D4.7 Annexe 2.a for a full list). In this list specific binding texts regarding ATMP development have been compiled. The list includes binding texts regarding medicinal products, medical devices, human cell and tissues, and ATMP specifically. In addition to binding texts, the legal watch has contributed to the identification and compilation of all the applicable guidance regarding ATMP development. (See D4.7 Annexe 2.b for a full list).

c) Collation of regulatory and ELSI information on gene and cell therapy

Due to the increasingly fast development of ATMPs and their regulation, it has been useful to get up-to-date information directly by attending relevant conferences, workshops, and seminars, and by creating thematic bibliographies listing all social and human sciences articles from relevant databases (see D4.7 Annexe 2c for full list of attended conferences, workshops, and seminars). These conferences, workshops, and seminars have given us thorough insights on the latest scientific developments in the field of gene and cell therapy (for instance, in the field of human genome editing), including on the latest regulatory developments (for instance, recent adoption of the French law on bioethics, adoption by the EMA on flowcharts on quality, non-clinical and clinical developments of ATMP).

The collection of information from EuroGCT partners has started. EuroGCT ELSI working groups are set up and each have agreed roadmaps for information collation. The ELSI Working groups are currently working on providing general overviews and full contents for each sub-entry of the Research Pathway Tree (see Ds 4.1 and 4.8).

The ELSI Bibliography on gene and cell therapy is compiled for each sub-entry of the Research Pathways section, and will be expanded as new sub-entries are developed.

d) Role of ELSI NoE

The ELSI Network of Expertise is operational while still being expanded. It has contributed to the review of templates. It is also involved in the reviews of the first factsheets being developed in WP3. It has also been involved in providing first drafts for the content of some sub-entries of the Research Pathways section, where the expertise was not available within the EuroGCT consortium (e.g. sub-entries on data protection). It will also be involved in providing lay summaries of social and human sciences literature and lay summaries of guidelines.

Finally, we note that all the methodological approaches of information collation have contributed to the development of general overview sub-entries in the Research Pathways section of the website, providing initial landscape mapping (see D4.8) and initial information on practical steps (see D4.9) as well as to the development of a EuroGCT strategy for stakeholder engagement with regulators (see D.4.4). They are now being used to complete the landscape mapping work for all sub-entries the Research Pathways section (see D4.1).

Conclusions and future steps

The methodological approach on information collation we have described constitutes the foundation of all information provision by WP4. The activities described in this deliverable are long-term and will continue to be reviewed and updated throughout the project's duration.

All of the aforementioned channels for information collation are active and have provided results. The information collected so far using the methodology described has been published in the Research Pathways section on the EuroGCT website, https://www.eurogct.org/research-pathways (see D4.2) and is also detailed in the Annexes to this deliverable. These annexes provide more details on the concrete methodological approaches have developed and implemented on collation of information relevant to researchers and regulators active in cell and gene therapy, and will be updated as the project progresses. Guidelines for Biologicals: drug product -Exact key word(s) and research method (« » ; * ; AND ; OR...).

List of Annexes

-Please be as precise as possible. This is all the more important than not all databases will support boolean research (for instance no * on Dalloz), or not all databases will offer the same advanced research options (some will offer to select a time frame from the beginning, others will only have it as a filter of results after; some will offer to specify that you want only the results where the keyword appears in, the title or abstract, some won't have this option and you may have to do it yourself...) -Adapt the language (French or English) to the chosen database and be specific on how you translated the key words (for instance regenerative medicine: médecine régénérative/régénératrice?; think of using the *) b) Total number of results from the data base: c) Further exclusion criteria: Any further filter that you can add after (either in the search functions of the database, or a relevance criterion that you have in mind when going through all the results) d) Final number of selected results: These results should be added to the relevant shared library.

  Deliverable Report ................................................................................................................ 1 List of acronyms .................................................................................................................... 4 0. Summary of D4.7 Resubmission ....................................................................................... 5 1. Objectives of the deliverable ............................................................................................. 5 2. Methodological approach .................................................................................................. 6 a) Scientific and legal research on existing gene and cell therapy general information 6 b) Legal watch for European Union legislation on gene and cell therapy ..................... 6 c) Research on information available on applicable guidelines ................................... 7 d) Participation in conferences and workshops to collect information .......................... 7 e) Collecting information from EuroGCT partners ........................................................ 7 f) Creation of ELSI Bibliography on gene and cell therapy ......................................... 7 g) Creation of templates .............................................................................................. 7 h) ELSI Network of Expertise ...................................................................................... 8 3. Summary of activities and outputs ..................................................................................... 8 a) Selection of a common terminology for use throughout EuroGCT ........................... 8 b) Collation of information on European Union legislation on gene and cell therapy .... 8 c) Collation of regulatory and ELSI information on gene and cell therapy.................... 9 4. Conclusions and future steps ............................................................................................ 9 5. List of Annexes ............................................................................................................... 10 Annexe 1. Scientific & Legal watch: consulted websites (updated July 2023) .............. 10 Annexe 2. Legal watch and research for information results ........................................ 10 2.a. List of binding texts (updated July 2023) ............................................................... 10 2.b. List of guidelines (updated July 2023) ................................................................... 10 2.c. List of attended conferences, workshops and seminars (updated July 2023) ........ 10 2.d. List of Social and Human Sciences databases ...................................................... 10 Annexe 3. Templates ................................................................................................... 10 3.a. Template of research record for bibliography ........................................................ 10 3.b. Template of lay summaries of Social and Human Sciences literature.................... 10 3.c. Template of lay summaries of Guidelines .............................................................. 10 3.d. Follow-up table for requests of lay summaries and translations............................. 10 Annexe 4. List of Social and Human Sciences research centres active on gene and cell therapy (updated July 2023)......................................................................................... 10

  Expertise. A EuroGCT template for lay summaries of social and human sciences literature (D4.7 Annexe 3.b.) and guidelines for lay summaries (D4.7 Annexe 3.c.) have been established. The two EuroGCT templates were reviewed by members of the ELSI Network of Expertise and by Partners 1 and 2. Finally, a follow-up table (D4.7 Annexe 3.d.) has been created to keep track of requests for lay summaries and translation.

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 1531 (EGA) https://ega-archive.org/ o RD-Connect online Genome-Phenome Analysis Platform https://platform.rdconnect.eu/ o DECIPHER (phenotypic and genotypic data) https://www.deciphergenomics.org/ o BBMRI-ERIC ELSI Knowledge Base: information on ELSI-related matters relevant to biobanking https://bbmri-eric.eu/elsi-knowledge-base/ o EU Clinical Trials Register https://www.clinicaltrialsregister.eu/ o Netherlands Trial Register https://www.trialregister.nl/ o Australian New Zealand Clinical Trials Registry https://www.anzctr.org.au/default.aspx o International Standard Randomised Controlled Trial Number Register (ISRCTN Register) https://www.isrctn.com/ o NIH Clinical Trials Database https://clinicaltrials.gov/ o The Journal of Gene Medicine clinical trial site https://a873679.fmphost.com/fmi/webd/GTCT o Clinical trials sponsored by NCI https://www.cancer.gov/aboutcancer/treatment/clinical-trials o WHO Human Genome Editing (HGE) Registry Human Genome Editing Registry (who.int)J. Publisher/Journals o Cell and Gene Therapy Insights http://www.insights.bio/cell-and-genetherapy-insights/home o Cell (and family of journal) https://www.cell.com/ o Springer Nature (and families of journals) https://www.nature.com/ and https://www.biomedcentral.com/ o Science (and family of journals) https://www.science.org/ o Frontiers (and family of journals) https://www.frontiersin.org/ o Cytotherapy https://www.isct-cytotherapy.org/ o EMBO Journal https://www.embopress.org/journal/14602075 o StemBook https://www.stembook.org/ o Human Gene Therapy https://www.liebertpub.com/loi/hum o Etc…. K. Other o RIS.WORLD & IFEP by White-Tillet o Regener8: http://www.regener8.ac.uk/ o RegMedNet: https://www.regmednet.com/ o Gènéthique o Forum européen de la bioéthique o Institut européen de bioéthique (IEB) o Gene Therapy Net https://www.genetherapynet.com/ 7) Personal data .......................................................................................... 29 I. Biological elements 1) Human blood Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance) C/2016/4641, OJ L 199, 26.7.2016, p. 14-Original text Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations (Text with EEA relevance), OJ L 366, 20.12.2014, p. 81-82 -Original text Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf-life Text with EEA relevance, OJ L 97, 12.4.2011, p. 28-29.-Original text Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance), OJ L 256, 1.10.2005, p. 41-48, CELEX number: 32005L0062 -Original text -Consolidated text -Document summary Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance), OJ L 256, 1.10.2005, p. 32-40, CELEX number: 32005L0061 -Original text Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance), OJ L 91, 30.3.2004, p. 25-39, CELEX number: 32004L0033 -Original text -Consolidated text Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC; OJ L 33, 8.2.2003, p. 30-40, CELEX number: 32002L0098 -Proposal (Proposal for a Directive of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC (COM (2000) 816 final -2000/0323 (COD)) (Text with EEA relevance); (Submitted by the Commission on 26 January 2001), OJ C 154E, 29.5.2001, p. 141-163, CELEX number: 52000PC0816) -Original text -Document summary 2) Human tissues and cells Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (Text with EEA relevance), OJ L 93, 9.4.2015, p. 56-68, CELEX number: 32015L0566 -Original text Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance), OJ L 93, 9.4.2015, p. 43-55, CELEX number: 32015L0565 -Original text Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells Text with EEA relevance, OJ L 327, 27.11.2012, p. 24-25, CELEX number: 32012L0039 -Original text 2010/453/EU: Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (notified under document C(2010) 5278) Text with EEA relevance, OJ L 213, 13.8.2010, p. 48-50, CELEX number: 32010D0453 -Original text Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance), OJ L 294, 25.10.2006, p. 32-50, CELEX number: 32006L0086 -Original text -Consolidated text Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance), OJ L 38, 9.2.2006, p. 40-52, CELEX number: 32006L0017 -Original text -Consolidated text Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 102, 7.4.2004, p. 48-58, CELEX number: 32004L0023 -Proposal (Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells (COM (2002) 319 final -2002/0128 (COD)), OJ C 227E, 24.9.2002, p. 505-521, CELEX number: 52002PC0319) -Amended proposal (Amended Proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells (presented by the Commission pursuant to Article 250 (2) of the EC Treaty), COM/2003/0340 final -COD 2002/0128, CELEX number: 52003PC0340) -Original text -Consolidated text -Document summary Substances of human origin (Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC) -Proposal II. Genetically Modified Organisms (GMOs) Clinical trials of medicinal products with GMOs for COVID-19 Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), OJ L 231, 17.7.2020, p. 12-16, CELEX number: 32020R1043 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease, COM/2020/261 final, CELEX number: 52020PC0261) -Original text 2) Contained use of Genetically Modified Micro-Organisms Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), OJ L 125, 21.5.2009, p. 75-97, CELEX number: 32009L0041 -Proposal (Proposal for a Directive of the European Parliament and of the Council on the contained use of genetically modified micro-organisms (Recast), COM/2007/0736 final -COD 2007/0259, CELEX number: 52007PC0736) -Original text -Document summary 2000/608/EC: Commission Decision of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (notified under document number C(2000) 2736) (Text with EEA relevance), OJ L 258, 12.10.2000, p. 43-48, CELEX number: 32000D0608 -Original text 3) Transboundary movements of GMOs Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (Text with EEA relevance), OJ L 287, 5.11.2003, p. 1-10, CELEX number: 32003R1946 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms, COM/2002/0085 final -COD 2002/0046, OJ C 151 E, 25.6.2002, p. 121-128, CELEX number: 52002PC0085) -Original text -Document summary 4) GMO Directive 2001-18 and amendments

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 1 Original text Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (Text with EEA relevance.), OJ L 231, 6.9.2019, p. 1-28, CELEX number: 32019R1381 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods], COM/2018/0179 final -2018/088 (COD), CELEX number: 52018PC0179) -Original text -Document summary Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms, OJ L 67, 9.3.2018, p. 30-45, CELEX number: 32018L0350 -Original text Commission Implementing Regulation (EU) No 120/2014 of 7 February 2014 amending Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and the Council as regards the Community reference laboratory for genetically modified organisms Text with EEA relevance, OJ L 39, 8.2.2014, p. 46-52, CELEX number: 32014R0120 -Original text 2009/770/EC: Commission Decision of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (notified under document C(2009) 7680) (Text with EEA relevance), OJ L 275, 21.10.2009, p. 9-27, CELEX number: 32009D0770 -Original text Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission, OJ L 81, 20.3.2008, p. 45-47, CELEX number: 32008L0027 -Proposal (Proposal for a Directive of the European Parliament and of the Council Amending Directive 2001/18/CE concerning the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred to the Commission, COM/2006/0920 final -COD 2006/0296, CELEX number: 52006PC0920) -Original text Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms (Text with EEA relevance), OJ L 368, 23.12.2006, p. 99-109, CELEX number: 32006R1981 -Original text -Consolidated text Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, OJ L 10, 16.1.2004, p. 5-10, CELEX number: 32004R0065 -Original text -Document summary 2002/813/EC: Council Decision of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market, OJ L 280, 18.10.2002, p. 62-83, CELEX number: 32002D0813 -Original text -Consolidated text 2002/812/EC: Council Decision of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products, OJ L 280, 18.10.2002, p. 37-61, CELEX number: 32002D0812 -Original text 2002/811/EC: Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 280, 18.10.2002, p. 27-36, CELEX number: 32002D0811 -Proposal (Proposal for a Council Decision establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC /* COM/2002/0359 final */ OJ C 262E , 29.10.2002, p. 325-335) -Original text Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC -Commission Declaration, OJ L 106, 17.4.2001, p. 1-39, CELEX number: 32001L0018 -Proposal (Proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, COM/98/0085 final -COD 98/0072, OJ C 139, 4.5.1998, p. 1, CELEX number: 51998PC0085) -Amended proposal (Amended proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, COM/99/0139 final -COD 98/0072, OJ C 139, 19.5.1999, p. 7, CELEX number: 51999PC0139) -Original text -Consolidated text -Document summary -Original text 96/134/EC: Commission Decision of 16 January 1996 amending Decision 91/448/EEC concerning guidelines for classification referred to in Article 4 of Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Text with EEA relevance), OJ L 31, 9.2.1996, p. 25-27, CELEX number: 31996D0134 -Original text 93/572/EEC: Commission Decision of 19 October 1993 concerning the placing on the market of a product containing genetically modified organisms pursuant to Article 13 of Council Directive 90/220/EEC, OJ L 276, 9.11.1993, p. 16-17, CELEX number: 31993D0572 -Original text 91/596/EEC: Council Decision of 4 November 1991 concerning the Summary Notification Information Format referred to in Article 9 of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, OJ L 322, 23.11.1991, p. 1-16, CELEX number: 31991D0596 -Proposal (Proposal For A Council Decision Concerning The Summary Notification Information Format Referred To In Article 9 Of Directive 90/220/Eec/* Com/91/282final */) -Original text -Consolidated text III. Medical Devices (MD) 1) Medical devices Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (Text with EEA relevance), C/2022/8638, OJ L 311, 2.12.2022, p. 94-96, CELEX 32022R2347 -Original textCommission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance), C/2022/8626, OJ L 311, 2.12.2022, p. 60-93, CELEX 32022R2346 -Original text Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment, C/2022/9, OJ L 1, 5.1.2022, p. 11-13, CELEX number: 32022D0006 -Original text Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices, C/2021/8984, OJ L 448, 15.12.2021, p. 32-38, CELEX number: 32021R2226 -Original text Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed), C/2021/8447, OJ L 426, 29.11.2021, p. 9-15, CELEX number: 32021R2078 -Original text Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance), C/2021/5866, OJ L 402, 15.11.2021, p. 65-68, CELEX number: 32021L1978 -Original text Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council, C/2021/5210, OJ L 256, 19.7.2021, p. 100-102, CELEX number: 32021D1182 -Original text Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects, C/2021/2434, OJ L 129, 15.4.2021, p. 158-160, CELEX number: 32021D0611 -Original text Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment, C/2021/2439, OJ L 129, 15.4.2021, p. 153-157, CELEX number: 32021D0610 -Original text Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products, C/2021/2432, OJ L 129, 15.4.2021, p. 150-152, CELEX number: 32021D0609-Original text Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance), OJ L 130, 24.4.2020, p. 18-22, CELEX number: 32020R0561 -Proposal (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions (Text with EEA relevance), COM(2020) 144 final, 2020/0060(COD) -Original text Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council, C/2020/1903, OJ L 90I, 25.3.2020, p. 33-39, CELEX number: 32020D0439 -Original text -Consolidated text Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC, C/2020/1902, OJ L 90I, 25.3.2020, p. 25-32, CELEX number: 32020D0438 -Original text -Consolidated text Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC, C/2020/1901, OJ L 90I, 25.3.2020, p. 1-24, CELEX number: 32020D0437 -Original text -Consolidated text Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices (Text with EEA relevance.), C/2019/6414, OJ L 234, 11.9.2019, p. 23-30, CELEX number: 32019D1396 -Original text Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (Text with EEA relevance.), C/2019/4068, OJ L 149, 7.6.2019, p. 73-75, CELEX number: 32019D0939 -Original text Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. ), C/2017/7779, OJ L 309, 24.11.2017, p. 7-17, CELEX number: 32017R2185 -Original text Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance), OJ L 117, 5.5.2017, p. 1-175, CELEX number: 32017R0745 -Proposal (Proposal for a Regulation of the European Parliament and the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, COM/2012/0542 final, 2012/0266 (COD), CELEX number: 52012PC0542) -Original text -Consolidated text -Document summary Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices Text with EEA relevance, OJ L 253, 25.9.2013, p. 8-19, CELEX number: 32013R0920 -Original text -Consolidated text Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Text with EEA relevance, OJ L 72, 10.3.2012, p. 28-31, CELEX number: 32012R0207 -Original text 2010/227/: Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (notified under document C(2010) 2363) (Text with EEA relevance), OJ L 102, 23.4.2010, p. 45-48, CELEX number: 32010D0227 -Original text Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance), OJ L 210, 12.8.2005, p. 41-43, CELEX number: 32005L0050 -Original text Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (Text with EEA relevance), OJ L 28, 4.2.2003, p. 43-44, CELEX number: 32003L0012 -Original text 2) In vitro diagnostic MD Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance), OJ L 117, 5.5.2017, p. 176-332, CELEX number: 32017R0746 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, /* COM/2012/0541 final -2012/0267 (COD) */), CELEX number: 52012PC0541 -Original text -Consolidated text -Document summary 2011/869/EU: Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) Text with EEA relevance, OJ L 341, 22.12.2011, p. 63-64, CELEX number: 32011D0869 -Original text 2009/886/EC: Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance), OJ L 318, 4.12.2009, p. 25-40, CELEX number: 32009D0886 -Original text -Consolidated text 2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (Text with EEA relevance) (notified under document number C(2002) 1344), OJ L 131, 16.5.2002, p. 17-30, CELEX number: 32002D0364 -Original text -Consolidated text 2002/65/EC: Commission Decision of 25 January 2002 on the national provisions concerning HIV testing kits notified under Article 95(4) of the EC Treaty by the United Kingdom as regards Directive 98/79/EC on in vitro diagnostic medical devices (Text with EEA relevance) (notified under document number C(2002) 297), OJ L 25, 29.1.2002, p. 47-48, CELEX 32002D0065 -Original text Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331, 7.12.1998, p. 1-37, CELEX number: 31998L0079 -Original text -Consolidated text -Document summary3) Implantable MD Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance), OJ L 212, 9.8.2012, p. 3-12, CELEX number: 32012R0722 -Original text IV. Medicinal products (MP) Innovative medicines / High-technology MP Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014, ST/12156/2021/INIT, OJ L 427, 30.11.2021, p. 17-119, CELEX 32021R2085 -Original text Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of hightechnology medicinal products, particularly those derived from biotechnology, OJ L 214, 24.8.1993, p. 40-40, CELEX number: 31993L0041 -Proposal (Proposal for a Council Directive repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products particularly those derived from biotechnology, COM/90/283 final -SYN 312, OJ C 330, 31.12.1990, p. 32-32, CELEX number: 51990PC0283(04)) -Original text2) Advanced therapy MP Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance), OJ L 242, 15.9.2009, p. 3-12, CELEX number: 32009L0120 -Original text Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (Text with EEA relevance), OJ L 194, 25.7.2009, p. 7-10, CELEX number: 32009R0668 -Original text Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance), OJ L 324, 10.12.2007, p. 121-137, CELEX number: 32007R1394 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (SEC (2005) 1444), COM/2005/0567 final -COD 2005/0227, CELEX number: 52005PC0567) -Original text -Consolidated text -Document summary 3) Medicinal Products for paediatric use Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use (Text with EEA relevance), OJ L 378, 27.12.2006, p. 20-21, CELEX number: 32006R1902 -Proposal (Proposal for a Regulation of the European Parliament and of the Council amending Regulation xxx/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, COM/2006/0640 final -COD 2006/0207, CELEX number: 52006PC0640) -Original text Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance), OJ L 378, 27.12.2006, p. 1-19, CELEX number: 32006R1901 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 {SEC (2004) 1144}, COM/2004/0599 final -COD 2004/0217, CELEX number: 52004PC0599) -Amended proposal (Amended proposal for a Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (presented by the Commission pursuant to Article 250 (2) of the EC Treaty), COM/2005/0577 final -COD 2004/0217, CELEX number: 52005PC0577) -Original text -Consolidated text -Document summary 4) Orphan medicinal products Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority', OJ L 103, 28.4.2000, p. 5-8, CELEX number: 32000R0847 -Original text -Consolidated text Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, OJ L 18, 22.1.2000, p. 1-5, CELEX number: 32000R0141 -Proposal (Proposal for a European Parliament and Council Regulation (EC) on orphan medicinal products, COM/98/0450 final -COD 98/0240, OJ C 276, 4.9.1998, p. 7, CELEX number: 51998PC0450) -Amended proposal (Amended proposal for a European Parliament and Council Regulation (EC) on orphan medicinal products, COM/99/0298 final -COD 98/0240, OJ C 177E, 27.6.2000, p. 1-10, CELEX number: 51999PC0298) -Original text -Consolidated text -Document summary 5) Clinical trials a) Clinical trials of MP with GMOs for COVID-19 Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), PE/28/2020/REV/1, OJ L 231, 17.7.2020, p. 12-16, CELEX number: 32020R1043 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease, COM/2020/261 final, CELEX number: 52020PC0261) -Original text b) Clinical trials Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use (Text with EEA relevance), C/2022/6240, OJ L 294, 15.11.2022, p. 5-7, CELEX 32022R2239 -Original text Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council (Text with EEA relevance), C/2021/5063, OJ L 275, 31.7.2021, p. 1-2, CELEX number: 32021D1240 -Original text Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance, OJ L 158, 27.5.2014, p. 1-76, CELEX number: 32014R0536 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, COM/2012/0369 final -2012/0192 (COD), CELEX number: 52012PC0369) -Original text -Consolidated text -Document summary Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1.5.2001, p. 34-44, CELEX number: 32001L0020 -Proposal (Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use, COM/97/0369 final -COD 97/0197, OJ C 306, 8.10.1997, p. 9-15, CELEX number: 51997PC0369) -Amended proposal (Amended proposal for a European Parliament and Council Directive on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, COM/99/0193 final -COD 97/0197, OJ C 161, 8.6.1999, p. 5, CELEX number: 51999PC0193) -Original text -Consolidated text -Document summary c) Investigational MP Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, OJ L 91, 9.4.2005, p. 13-19, CELEX number: 32005L0028 -Original text 6) Community Code MP Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), OJ L 136, 30.4.2004, p. 34-57, CELEX number: 32004L0027 -Proposal (Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM (2001/0404 final -2001/0253(COD)), OJ C 75E, 26.3.2002, p. 216-233, CELEX number: 52001PC0404(02)) -Original text Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance), OJ L 159, 27.6.2003, p. 46-94, CELEX number: 32003L0063 -Original text Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67-128, CELEX number: 32001L0083 -Proposal (Proposal for a European Parliament and Council Directive on the Community code relating to medicinal products for human use -(codified version), COM/99/0315 final -COD 99/0134, CELEX number: 51999PC0315) -Original text -Consolidated text -Document summary 7) European Medicines Agency (EMA) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance), PE/76/2021/REV/1, OJ L 20, 31.1.2022, p. 1-37, CELEX 32022R0123 -Original text Commission Regulation (EU) 2020/422 of 19 March 2020 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020, OJ L 84, 20.3.2020, p. 11-14, CELEX number: 32020RO422 -Original text Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), PE/44/2018/REV/1, OJ L 4, 7.1.2019, p. 24-42, CELEX number: 32019R0005 -Proposal (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, COM/2014/0557 final -2014/0256 (COD), CELEX number: 52014PC0557) -Original text Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance), OJ L 189, 27.6.2014, p. 112-127, CELEX number: 32014R0658 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use, COM/2013/0472 final -2013/0222 (COD), CELEX number: 52013PC0472) -Original text -Consolidated text Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance), OJ L 136, 30.4.2004, p. 1-33, CELEX number: 32004R0726 -Proposal (Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (COM (2001) 404 final -2001/0252(COD)), OJ C 75E, 26.3.2002, p. 189-215, CELEX number: 52001PC0404(01)) -Modified proposal (Modified proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty), COM/2002/0735 final -COD 2001/0252, CELEX number: 52002PC0735) -Original text -Consolidated text -Document summary Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, OJ L 35, 15.2.1995, p. 1-5, CELEX number: 31995R0297 -Proposal (Proposal for a Council Regulation (EC) on fees payable to the European Medicines Evaluation Agency, COM/94/167 final, OJ C 398, 31.12.1994, p. 20-23, CELEX number: 51994PC0167) -Original text -Consolidated text 8) Falsified MP Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance), OJ L 174, 1.7.2011, p. 74-87, CELEX number: 32011L0062 -Proposal (Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source {SEC (2008) 2674} {SEC (2008) 2675}, COM/2008/0668 final -COD 2008/0261, CELEX number: 52008PC0668) -Original text 9) Manufacturing and packaging Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (Text with EEA relevance), C/2017/6127, OJ L 238, 16.9.2017, p. 44-50, CELEX number: 32017L1572 -Original text Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance), C/2017/3368, OJ L 238, 16.9.2017, p. 12-21, CELEX number: 32017R1569 -Original text Commission delegated regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, OJ L 32, 9.2.2016, pp. 1-27. -Original text -Consolidated text Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use Text with EEA relevance, OJ L 337, 25.11.2014, p. 1-7, CELEX number: 32014R1252 -Original text Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance), OJ L 91, 9.4.2005, p. 13-19, CELEX number: 32005L0028 -Original text 10) Marketing authorisations/patent Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the supplementary protection certificate for medicinal products (recast), 27.4.2023, COM/2023/231 final, CELEX 52023PC0231 -Proposal Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance.) PE/52/2019/REV/1, OJ L 153, 11.6.2019, p. 1-10. -Proposal -Original text Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Text with EEA relevance), OJ L 168, 30.6.2009, p. 33-34, CELEX number: 32009L0053 -Proposal (Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products {SEC (2008) 273} {SEC (2008) 274}, COM/2008/0123 final -COD 2008/0045, CELEX number: 52008PC0123) -Original text Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance), OJ L 334, 12.12.2008, p. 7-24, CELEX number: 32008R1234 -Original text -Consolidated text Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance), OJ L 92, 30.3.2006, p. 6-9, CELEX number: 32006R0507 -Original text 11) Pharmacovigilance Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (Text with EEA relevance), OJ L 65, 8.3.2013, p. 17-18, CELEX number: 32013R0198 -Original text Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (Text with EEA relevance), OJ L 299, 27.10.2012, p. 1-4, CELEX number: 32012L0026 -Proposal (Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance, COM/2012/052 final -2012/0025 (COD), CELEX number: 52012PC0052) -Original text Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (Text with EEA relevance), OJ L 316, 14.11.2012, p. 38-40, CELEX number: 32012R1027 -Proposal (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance, COM/2012/051 final -2012/0023 (COD), CELEX number: 52012PC0051) -Original text Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), OJ L 159, 20.6.2012, p. 5-25, CELEX number: 32012R0520 -Original text Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance), OJ L 348, 31.12.2010, p. 74-99, CELEX number: 32010L0084 -Proposal (Proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use {SEC (2008) 2670} {SEC(2008) 2671}, COM/2008/0665 final -COD 2008/0260, CELEX number: 52008PC0665) -Original text -Consolidated text Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (Text with EEA relevance), OJ L 348, 31.12.2010, p. 1-16, CELEX number: 32010R1235 -Proposal (Proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency {SEC (2008) 2670} {SEC (2008) 2671}, COM/2008/0664 final -COD 2008/0257, CELEX number: 52008PC0664) -Original text -) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union's action in the field of health ('EU4Health Programme') for the period 2021-2027, and repealing Regulation (EU) No 282/2014, OJ L 107, 26.3.2021, pp. 1-29, CELEX number: 32021R0522 -Proposal -Original text 2) Research and Innovation Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority, 2021/C 393 I/02C/2021/6712, OJ C 393I , 29.9.2021, p. 3-8, CELEX 32021D0929(02) -Original text Regulation (EU) 2021/819 of the European Parliament and of the Council of 20 May 2021 on the European Institute of Innovation and Technology (recast), OJ L 189, 28.5.2021, p. 61-90, CELEX 32021R0819 -Original text Decision (EU) 2021/820 of the European Parliament and of the Council of 20 May 2021 on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT) 2021-2027: Boosting the Innovation Talent and Capacity of Europe and repealing Decision No 1312/2013/EU (Text with EEA relevance), PE/9/2021/REV/1, OJ L 189, 28.5.2021, p. 91-118, CELEX 32021D0820 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe -the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013, OJ L 170, 12.5.2021, p. 1-68, CELEX number: 32021R0695. -Original text -Document summary Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe -the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU, ST/8967/2020/INIT, OJ L 167I , 12.5.2021, p. 1-80, CELEX 32021D0764 -Original text Decision No 554/2014/EU of the European Parliament and of the Council of 15 May 2014 on the participation of the Union in the Active and Assisted Living Research and Development Programme jointly undertaken by several Member States, OJ L 169, 7.6.2014, p. 14-26, CELEX 32014D0554 -Original text 2013/743/EU: Council Decision of 3 December 2013 establishing the specific programme implementing Horizon 2020 -the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC Text with EEA relevance, OJ L 347, 20.12.2013, p. 965-1041, CELEX 32013D0743 -Original text Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the regions Introducing HERA, the European Health Emergency preparedness and Response Authority, the next step towards completing the European Health Union, COM/2021/576 final, CELEX 52021DC0576 -Original text 3) Price and reimbursement Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU, OJ L 458, 22 December 2021, p. 1-32, CELEX number: 32021R2282 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM/2018/051 final -2018/018 (COD), CELEX number: 52018PC0051) -Original text Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (Text with relevance for the EEA and for Switzerland), OJ L 166, 30.4.2004, p. 1-123, CELEX number: 32004R0883 -Proposal (Proposal for a Council Regulation (EC) on coordination of social security systems, COM/98/0779 final -AVC 98/0360, OJ C 38, 12.2.1999, p. 10, CELEX number: 51998PC0779) -Original text -Consolidated text -Document summary Amended proposal for a Directive of the European Parliament and of the Council on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems, COM/2013/0168 final -2012/0035 (COD), CELEX number: 52013PC0168 -Amended proposal Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems, OJ L 40, 11.2.1989, p. 8-11, CELEX number: 31989L0105 -Proposal (Proposal for a Council Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of the national health insurance system, COM/86/765 final -SYN 79, OJ C 17, 23.1.1987, p. 6-9, CELEX number: 51986PC0765) -Amended proposal (Amended proposal for a Council Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within in the scope of national the health insurance system, COM/88/231 final -SYN 79, OJ C 129, 18.5.1988, p. 14-18, CELEX number: 51988PC0231) -Original text -Document summary 4) Cross-border patients' rights Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare, OJ L 88, 4.4.2011, p. 45-65, CELEX number: 32011L0024 -Proposal (Proposal for a Directive of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare {SEC (2008) 2163} {SEC (2008) 2164} {SEC (2008) 2183}, COM/2008/0414 final -COD 2008/0142, CELEX number: 52008PC0414) -Original text -Consolidated text -Document summary5) Legal protection of biotechnological inventions Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213, 30.7.1998, p. 13-21, CELEX number: 31998L0044 Proposal 1 (Proposal for a Council Directive on the legal protection of biotechnological inventions, COM/88/496 final -SYN 159 OF 17/10/88, OJ C 10, 13.1.1989, p. 3-8, CELEX number: 51988PC0496) -Amended proposal 1 (Amended proposal for a Council Directive on the legal protection of biotechnological inventions, COM/92/589 final -SYN 159, OJ C 44, 16.2.1993, p. 36-50, CELEX number: 51992PC0589) -Proposal 2 (Proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions, COM/95/0661 final -COD 95/0350, OJ C 296, 8.10.1996, p. 4-10, CELEX number: 51995PC0661) -Amended Proposal 2 (Amended proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions, COM(97) 446 final, 95/ 0350 (COD), Brussels, 29.08.1997) -Original text -Document summary6) Creation of unitary patent protection Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection, OJ L 361, 31.12.2012, p. 1-8, CELEX number: 32012R1257 -Proposal (Proposal for a Regulation of the European Parliament and of the Council implementing enhanced cooperation in the area of the creation of unitary patent protection, COM/2011/0215 final -2011/0093 (COD), CELEX number: 52011PC0215) -Original text -Document summary Council Regulation (EU) No 1260/2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements, OJ L 361, 31.12.2012, p. 89-92, CELEX number: 32012R1260. -Original text -Document summary Agreement on a Unified Patent Court, OJ C 175, 20.6.2013, p. 1-40, CELEX number:42013A0620(01) -Original text -Document summary Council Decision 2011/167/EU of 10 March 2011 authorising enhanced cooperation in the area of the creation of unitary patent protection, OJ L 76, 22.3.2011, p. 53-55, CELEX 32011D0167 -Original text Agreement 89/695/EEC relating to Community patents -Done at Luxembourg on 15 December 1989, OJ L 401, 30.12.1989, p. 1-27, CELEX 41989A06995(01) -Original text 7) Personal data Proposal for a regulation of the European Parliament and of the Council on the European health data space, COM/2022/197 Final, CELEX 52022PC0197 -Proposal Proposal for a regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence and amending certain Union legislative acts, 2021/0106(COD), Doc. ST_15698_2022_INIT -Proposal Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (Text with EEA relevance.), PE/31/2018/REV/1, OJ L 295, 21.11.2018, p. 39-98, CELEX number: 32018R1725 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC, COM/2017/08 final -2017/02 (COD), CELEX number: 52017PC0008) -Original text -Document summary Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA, OJ L 119, 4.5.2016, p. 89-131, CELEX 32016L0680 -Original text Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance), OJ L 119, 4.5.2016, p. 1-88, CELEX number: 32016R0679 -Proposal (Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation), COM/2012/011 final -2012/0011 (COD), CELEX number: 52012PC0011) -Proposal (Proposal for a Directive of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by competent authorities for the purposes of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and the free movement of such data, COM/2012/010 final -2012/0010 (COD), CELEX number: 52012PC0010) -Original text -Consolidated text -Document summary Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases, JO L 77 du 27.3.1996, p. 20-28, CELEX 31996L0009 -Original text EuroGCT Annex 2.b to Deliverable D.4.7 List of Guidelines applicable to Advanced Therapy Medicinal Products I.

3 .

 3 Guidelines for medicinal products containing genetically modified cells  EMA, CAT, Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, EMA/CAT/GTWP/671639/2008 Rev. 1 -corr, 12 November 2020, https://www.ema.europa.eu/en/quality-non-clinical-clinical-aspects-medicinalproducts-containing-genetically-modified-cells  EMA, CAT, Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells, EMA/CAT/CHMP/158266/2021, 10 May 2022, https://www.ema.europa.eu/en/guideline-core-smpc-labelling-package-leafletadvanced-therapy-medicinal-products-atmps-containing 4.

o

  A-Gene Webinar Series -Alliance for Regenerative Medicine (on demand) o A-Cell Webinar Series -Alliance for Regenerative Medicine (on demand) o Future of ATMPs in Europe -Alliance for Regenerative Medicine, November 29 2022  Webinar hosted by Cell and Gene Therapy Insights: o The CAR Toolkit: Progress and Challenges in CAR T/NK Cell R&D and manufacture, 07 Dec 2022  EATRIS ADVANCE Webinars: o European Innovation Council (EIC) and European Medicine Agency (EMA) Info Day, 31 Jan 2023 o ADVANCE Webinar: ATMP Market Access, 20 Dec 2022 o EATRIS and EMA Present: Webinar on Support for Academic and Non-Profit ATMP Developers, 01 Dec 2022 o ADVANCE Webinar -Manufacturing of ATMPs, 29 Nov 2022 o Training seminar in regulatory knowledge, 05 Oct 2022 o ADVANCE Webinar: Regulatory & Clinical Aspects of ATMPs, 31 May 2022  Webinar hosted by NVIDIA: o The Impact of Large Language Models (LLM) on Life Sciences, 11 May 2023  Webinar hosted by FierceBiotech: o Navigating the Current Launch Landscape Trends, 29 Jun 2023  Webinars hosted by Bioanalysis Zone: o Best Practices for laboratory solutions relating to cell and gene therapy clinical trials, 7 Dec 2022 o Validating flow cytometry assays for cell and gene therapies, 10 Nov 2022 Workshop Hosted  EuroGCT Sharing best practice workshop, Edinburgh, UK, 10 Oct 2022  Generative AI and Gene and Cell Therapy Information Workshop, hosted by University of Edinburgh, ReNEW and the University of Copenhagen, Copenhagen, Denmark, 17-18 Apr 2023 EuroGCT Annex 3.a to Deliverable D.4.7Template Research Record for bibliographyThis template below should be copied and pasted for each research on scientific databases.NAME of the BibliographyName of the researcher:Date of the research:Last updated:Topic of the research:For EACH below database:a) Precise research method:

  number of results included in Zotero

  Annexe 1. Scientific & Legal watch: consulted websites (updated July 2023) Annexe 2. Legal watch and research for information results 2.a. List of binding texts applicable to ATMP development (updated July 2023) 2.b. List of guidelines applicable to Advanced Therapy Medicinal Products (updated July 2023) 2.c. List of attended conferences, workshops and seminars (updated July 2023) 2.d. List of Social and Human Sciences databases Annexe 3. Templates 3.a. Template of research record for bibliography 3.b. Template of lay summaries of Social and Human Sciences literature 3.c. Template of lay summaries of Guidelines 3.d. Follow-up table for requests of lay summaries and translations Annexe 4. List of Social and Human Sciences research centres active on gene and cell therapy (updated July 2023)

		-EUnetHTA
	1.	European Union
		o Guidance documents
		o Tools and resources
		-European Commission (EC) :
		o On Public health policy : « blood, tissues, and organs »,
		« health technology assessment », « medicinal products for
		human use », « medical devices », « research and
		innovation in health »
		o Research and Innovation
		o Single market
		-European Group on Ethics in Science and New Technologies
		(EGE)
		-Court of Justice of the EU
		-Expert Panel on effective ways of investing in health

-European Medicines Agency (EMA): o The latest news o « Open consultations » and « Events » (Potential events to be reported on our conference doc and on ELSIBI) in « News & Events » o CAT Monthly reports (https://www.ema.europa.eu/en/committees/cat/catagendas-minutes-reports#minutes-section) -European Data Protection Board (EDPB) https://edpb.europa.eu/edpb_en -European Network of Research Ethics Committees (EUREC)

  International Rare Diseases Research Consortium (IRDiRC) o The International Alliance for Biological Standardization (IABS) o Forum for Innovative Regenerative Medicine (FIRM) o European Union Drug Regulating Authorities Clinical Trials Database

	2. 3. C. France Council of Europe -European Directorate for the Quality of Medicines and Healthcare (EDQM) -Committee on Bioethics (DH-BIO) -European Committee on Organ Transplantation (CD-P-TO) -European Committee on Blood Transfusion (CD-P-TS) Other -Netherlands Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare and Sport -Norway Norwegian Medicines Agency (NoMA) -Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products -Poland Chief Pharmaceutical Inspectorate -Portugal National Authority of Medicines and Health Products (INFARMED) -Romania National Authority of Medicines and Medical Devices of Romania -Slovakia State Institute for Drug Control -Council for International Organizations of Medical Sciences (CIOMS) https://cioms.ch/ -World Health Organization (WHO) -Organisation for Economic Co-operation and Development (OECD) https://www.oecd.org/ -Comité Consultatif National d'Éthique (CCNE) -ANSM (Agence National de Sécurité du Médicament et des produits de santé) E. USA -National Center for Advancing Translational Sciences (NCATS) https://toolkit.ncats.nih.gov/ -National Institute of Standards and Technology (NIST) https://www.nist.gov/ -National Institutes of Health (NIH) https://www.nih.gov/ C. Business Associations o Leem Les entreprises du médicament o Map MedTech (News) o Map BioPharma (News) o UK Bioindustry Association (BIA): http://www.bioindustry.org/home/ o EuropaBio o Alliance for Regenerative Medicine https://alliancerm.org/ o Health Research Charities Ireland (HRCI) https://hrci.ie/ I. Biobanks, registries, databases o European Bank For Induced Pluripotent Stem Cells (EBiSC) o Human pluripotent stem cell registry (hPSCreg) https://hpscreg.eu/ o EuroBioBank http://www.eurobiobank.org/ o F. Translational research centres, organisations o The Association of the British Pharmaceutical Industry (ABPI) https://www.abpi.org.uk/ o EATRIS https://eatris.eu/ o UK Biobank https://www.ukbiobank.ac.uk/ o The National Gene Vector Biorepository (NVGB) III. Scientific/societal sources o BioPhorum C&GT https://www.biophorum.com/phorum/cell-and-gene-o The Global Alliance for iPSC Therapies (GAiT) http://www.gait.global/ https://www.ngvbcc.org/Home.action -Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia -Sweden Swedish Medical Products Agency -Office parlementaire d'évaluation des choix scientifiques et technologiques (OPECST) https://www.efpia.eu/ o Société Française de Thérapie Génique et Cellulaire o European Federation of Pharmaceutical Industries and Associations (EFPIA) o CCRM https://www.ccrm.ca/ -Spain Spanish Agency for Medicines and Health Products -Agence de la biomédecine -Haute Autorité de Santé (HAS) o ATMP manufacture group https://atmpmanufacture.org o ECRIN https://ecrin.org/ A. Learned Societies therapy/ o Cell and Gene Therapy Catapult https://ct.catapult.org.uk/ o
	o European Society of Gene and Cell Therapy o European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
	-European Patent Office (EPO) National Medicines Agencies -Austria Austrian Agency for Health and Food Safety -Belgium Federal Agency for Medicines and Health Products (FAMHP) -Bulgaria Bulgarian Drug Agency -Croatia Agency for medicinal products and medical devices of Croatia -Cyprus Ministry of Health -Pharmaceutical Services -Czechia State Institute for Drug Control -Denmark Danish Medicines Agency -Estonia State Agency of Medicines -Finland Finnish Medicines Agency -France National Agency for the Safety of Medicine and Health Products -Germany Federal Institute for Drugs and Medical Devices -Germany Paul Ehrlich Institute -Greece National Organization for Medicines -Hungary National Institute of Pharmacy and Nutrition -Iceland Icelandic Medicines Agency -Ireland Health Products Regulatory Authority (HPRA) -Italy Italian Medicines Agency (AIFA) -Latvia State Agency of Medicines -Liechtenstein Office of Health / Department of Pharmaceuticals -Lithuania State Medicines Control Agency -Luxembourg Ministry of Health -Malta Malta Medicines Authority (MMA) -Netherlands Medicines Evaluation Board National Health Technology Assessment (HTA) o International Society for Cellular Therapy (ISCT): 4. 5. D. UK http://www.celltherapysociety.org/ https://www.eucope.org/ G. Related projects Bodies -Austria Austrian Institute for Health Technology Assessment (AIHTA) -Belgium Belgian Health Care Knowledge Centre (KCE) -England The National Institute for Health and Care Excellence (NICE) -France Haute Autorité de Santé (HAS) -Hungary National Institute of Pharmacy and Nutrition (OGYÉI) -Germany Gemeinsamer Bundesausschuss (GBA) -Germany The independent Institute for Quality and Efficiency in -Human Tissue Authority (HTA) -Medicines & Healthcare products Regulatory Agency (MHRA) -NHS Blood and Transplant (NHSBT) -UK Research and Innovation (UKRI) -Department of Health and Social Care -Nuffield Council on Bioethics -Cell and Gene Therapy Catapult -HFEA -National Institute for Health and Care Excellence (NICE) https://www.nice.org.uk/ o International Society for Stem Cell Research (ISSCR): http://www.isscr.org/ o American Society of Gene and Cell Therapy https://asgct.org/ o European Joint Programme on Rare Diseases (EJP RD) D. National and regional networks https://www.ejprarediseases.org/ o The British Society for Immunology https://www.immunology.org/ o RESTORE https://www.restore-horizon.eu/opportunity/ o European Society of Human Genetics (ESHG) o ATMP Sweden https://atmpsweden.se/ o ADVANCE https://eatris.eu/projects/advance/ o American Society of Gene & Cell Therapy (ASGCT) o Stem Cells Australia https://stemcellsaustralia.edu.au/ o Transmed Academy https://eatris.eu/transmed-academy/ o Australasian Gene and Cell Therapy Society (AGCTS) o The Advanced Therapy Treatment Centres (ATTC) Network o T2Evolve https://t2evolve.com/ o German Gene Therapy Society (DGGT) https://www.theattcnetwork.co.uk/ o COST Action HAPLO-iPS o Netherlands Society of Gene and Cell Therapy (NVGCT) o Academic Health Science Networks (AHSNs) https://www.ahsnnetwork.com/ o AUTOSTEM o Swedish Society of Gene and Cell Therapy (SSGCT) o NHLBI Gene Therapy Resource Program https://www.gtrp.org/ o AIDPATH o Society for Inherited Metabolic Disorders (SIMD) o NIST Genome Editing Consortium https://www.nist.gov/programs-o COST Action CorEuStem -The European Network for Stem Cell Core Health Care (IQWiG) -Accelerated Access Collaborative (AAC) projects/nist-genome-editing-consortium Facilities -Ireland The National Centre for Pharmacoeconomics (NCPE) https://www.nice.org.uk/aac o ATMP Manufacturing Ireland o GAPP JOINT ACTION -Co-Funded by the Health Programme of the EU -Italy Italian Medicines Agency (AIFA) -Netherlands The National Health Care Institute (ZIN) -Parliamentary Office of Science & Technology (POST) -House of Lords Science & Technology Committee o Advanced Therapy Network (ATN) o I-BioLex -Fragmentation and defragmentation of the law on biomedical B. Patient Associations o Deutsche Gesellschaft für Gentherapie e.V. (DG-GT) innovations -Norway Norwegian Medicines Agency (NoMA) -Portugal National Authority of Medicines and Health Products (INFARMED) -Scotland Scottish Medicines Consortium (SMC) -Spain Spanish Agency for Medicines and Health Products (AEMPS) -Sweden Tandvårds-och läkemedelsförmånsverket (TLV) B. International -International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) -International Bioethics Committee (IBC) of the UNESCO -National Institute for Biological Standards and Control (NIBSC): http://www.nibsc.org/ (which hosts the UK stem cell bank) o German Stem Cell Network for Basic & Applied Stem Cell Research o SIENNA Project o Orphanet surtout « Actualités politiques » dans la Newsletter Orphanews https://gscn.org/ o Strengthening Training of Academia in Regulatory Science (CSA STARS) o The Patients Network for Medical Research and Health (EGAN): o European Society for Blood and Marrow Transplantation (EBMT) https://www.csa-stars.eu/index.html -The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) http://www.egan.eu/ o EuroStemCell o PaVe-GT: Paving the Way for Rare Disease Gene Therapies https://pave-o European Organisation for Rare Diseases (Eurordis): o University College London (UCL) Future Targeted Healthcare Manufacturing gt.ncats.nih.gov/ -National Institute for Health Research (NIHR) http://www.eurordis.org/fr Hub https://www.ucl.ac.uk/biochemical-engineering/research/research-and-https://www.nihr.ac.uk/ o Genetic Alliance UK https://geneticalliance.org.uk/ training-centres/future-targeted-healthcare-manufacturing-hub -Innovate UK https://www.ukri.org/councils/innovate-uk/ o Patient Engagement Management Suite https://pemsuite.org/ o Innovative Genomics Institute (IGI) at UC Berkeley and UCSF -UKRI Innovate UK KTN https://iuk.ktn-uk.org/ -National Health Service (NHS) https://www.nhs.uk/ -UK Information Commissioner's Office (ICO) https://ico.org.uk/ o European Patients' Forum www.eu-patient.eu o European Patients' Academy on Therapeutic Innovation (EUPATI) H. Charities E. International consortium and networks https://eupati.eu/ o Association of Medical Research Charities (AMRC) https://www.amrc.org.uk/ o Lung Cancer Europe (LuCE) https://www.lungcancereurope.eu/ o Global Alliance for Genomics and Health (GA4GH) https://www.ga4gh.org/ o Health data research UK (HDR UK) https://www.hdruk.ac.uk o Parkinson's UK https://www.parkinsons.org.uk/ o International Consortium for Personalised Medicine -ICPerMed o Shared Learning Group on Involvement https://slginvolvement.org.uk/

(EudraCT) https://eudract.ema.europa.eu/ o VigiBase https://www.who-umc.org/vigibase/vigibase/ o EudraVigilance https://www.ema.europa.eu/en/human-regulatory/researchdevelopment/pharmacovigilance/eudravigilance and https://www.adrreports.eu/en/index.html o HealthData https://healthdata.gov/ o The European Genome-phenome Archive

authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of, or produced from certain genetically modified organisms

  (notified under document C(2021) 5148) (Text with EEA relevance) (Only the Dutch text is authentic), C/2021/5148, OJ L 252, 15.7.2021, p. 1-6, CELEX number: 32021D1161

	Commission Implementing Decision (EU) 2021/1161 of 13 July 2021 amending Decision
	2011/891/EU and Implementing Decisions (EU) 2017/1211, (EU) 2017/1212, (EU) 2017/2449,
	(EU) 2019/2085 and (EU) 2019/2086 as regards the -Original text
	Commission Implementing Decision (EU) 2021/184 of 12 February 2021 amending
	Decisions 2009/813/EC, 2009/814/EC and 2010/429/EU and Implementing Decisions
	2012/82/EU, 2012/83/EU, 2012/347/EU, 2013/649/EU, (EU) 2015/683, (EU) 2015/684, (EU)
	2015/685, (EU) 2015/686, (EU) 2015/687, (EU) 2015/688, (EU) 2015/689, (EU) 2015/693,
	(EU) 2015/695, (EU) 2015/696, (EU) 2015/700, (EU) 2015/701, (EU) 2015/2279, (EU)
	2015/2281, (EU) 2016/1216, (EU) 2016/1217, (EU) 2017/1207, (EU) 2018/1111, (EU)
	2018/2045, (EU) 2018/2046, (EU) 2019/1307, (EU) 2019/1308, (EU) 2019/1309, (EU)
	2019/2083 and (EU) 2020/1360 as regards the

authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of or produced from certain genetically modified organisms (

	notified under document C(2021)
	826) (Only the Dutch text is authentic) (Text with EEA relevance), C/2021/826, OJ L 55,
	16.2.2021, p. 4-23, CELEX number: 32021D0184

Table of contents

 of II. Guidelines applicable to allATMPs or some ATMPs ..................................... . Notes for guidance ................................................................................................ . Notes for guidance specific to ATMPs ................................................................................. 2. Notes for guidance on Biologicals: drug product .................................................................

	1

E

  EWP/83561/2005, 27 July 2006, https://www.ema.europa.eu/en/clinical-trialssmall-populations  EMA, CPMP, Points to consider on applications with 1. Meta-analyses; 2. /BWP/1143/00, 1 March 2001, https://www.ema.europa.eu/en/use-tumorigeniccells-human-origin-production-biological-biotechnological-medicinal-products University of Edinburgh and University of Aix-Marseille project teams attended the following conferences, workshops and seminars from February 2021 to January 2022: Conferences  SCI:COM 2021 "Shaping the story of science and research in Europe"  International Society for Stem Cell Research Annual Meeting  King's BHF Centre for Research Excellence Annual Symposium  31st Annual Meeting of Network for European CNS Transplantation and Restoration and 16th International Symposium on Neural Transplantation and Repair  Royal Society of Biology Connect 2021: "Bringing outreach and engagement into the future"  British Society for Immunology Annual Congress  Chaire UNESCO, Chaire Jean Monnet, Inserm, Toulouse, « Analyse des risques en santé : entre droit(s), science, éthique et attente sociétale, approches européenne et nationale », Link to publication : http://publications.ut-capitole.fr/42480/ , 12 March 2021,  Association Française de Droit de la Santé, Défiance et Santé, 27 May 2021  Université de Lorraine, CEDH et Biodroit, 18 June 2021  Universidad International Menendez Pelayo (UIMP), Basis for redesigning a postpandemic health system, 1st July 2021  Eurobiomed, "Rencontres Médicaments de thérapie innovante », 14 September 2021  Agence de la Biomédecine, Journées de l'Agence de la biomédecine, 7-8 October 2021: https://www.journees-agence-biomedecine.fr/programme  Chaire UNESCO « Éthique, science et société » et Institut Maurice Hauriou, Colloque Révision de la loi relative à la bioéthique, 14-15 October 2021 : Hosted by Centre for Law, Medicine and Life Sciences, University of Cambridge, Orphan Drug Innovation: Needs and Priorities, 17 September 2021 Seminars Cell and Gene Therapy Catapult Seminars: o Patient and public perspectives on cell and gene therapies o Solid tumour treatment with ATMPs o Pluripotent Stem Cell-derived advanced therapies o Accelerating delivery of cellular therapy trials o Out of specification ATMPs o Moving from autologous to allogeneic o Know your cells o Building a robust scaling strategy for stem cell manufacture  Cell and Gene Therapy Insights: o Automated cell expansion: Current technologies and trends o Overcoming challenges in analytical assays for cellular therapies  ADVANCE Webinars: Towards a Healthy European Semester through 'Green and Inclusive Growth'? Hosted by EUPHA (The European Public Health Association), o Unleashing the Power of Law to Promote Better Health for All, 20 May 2021 o The Oslo Medicines initiative : a new social contract with pharma, 11 June 2021  Hosted by Institut für Ethik und Geschichte der Medizin Göttingen, Is it justifiable to edit the human germline? The 2020 Geneva Statement, 1 st June 2021  Hosted by Gene & Cell Therapy Institute:Table ronde n°3 : Europe de la Santé : bilan et perspectives pour 2022-2023, 22 October 2021 : https://www.nile-consulting.eu/portfolio-item/colloqueeurope-de-la-sante/  Hosted by EU Health Policy Platform: o EU Health Policy Platform Pitch webinar, 2021 Thematic Network semifinalists, Wednesday 7 July 2021 o Thematic network "Health as a fundamental value. Towards an equitable and inclusive pharmaceutical strategy for the EU", EU Health Policy Platform Kickoff meeting, 2021 Thematic Networks, Friday 24 September 2021 o "EU values and health digitalization: the inclusion of vulnerable groups", Regulatory possibilities to enhance cooperation among the EU's governance structures and complementarity within the EU acquis", European Union Health Policy Platform, 2021 Thematic Network on « Health as fundamental value: Towards an equitable and inclusive pharmaceutical strategy for the EU", 10 January 2022. University of Edinburgh and University of Aix-Marseille project teams attended the following conferences, workshops, and seminars from February 2022 to July 2023: ESGCT 29 th Annual Congress, European Society of Gene and Cell Therapy in collaboration with British Society for Gene and Cell Therapy Gene and Cell Therapy -Posters presentation, Edinburgh, Scotland, 11-14 October 2022  15 th European Public Health Conference, European Public Health Conference Foundation European Public Health Conference Foundation Strengthening health systems: improving population health and being prepared for the unexpected, Berlin, Germany, 9-12 November 2022  Biosimilar medicines: multistakeholder event, Brussels, Belgium, 13 December 2022  49 th Annual Meeting of the European European Society for Blood and Marrow Transplantation Key issues relating to HSCT and cellular therapy research, Paris, France, 23-26 April 2023  The Next Frontiers in ATMP Development, DG-GT (Deutsche Gesellschaft für Gentherapy), Paul-Ehrlich-Institut Langen, Germany, 27-28 April 2023  Cell & Gene Therapy Insights Commercializing cell and gene therapies: Navigating complex commercial readiness hurdles for a successful product launch, Online event, 9 May 2023  Annual meeting of the International Society for Gene and Cell Therapy International Society for Gene and Cell Therapy Celebrating the progress of Advanced Therapies and building the Future through translations, Paris, France, 31 May-3 June 2023  ITEGOREC, Innovations technologiques et greffe d'organes : enjeux réglementaires, éthiques et culturels (organoïdes), Compiègne, France, 14 June 2023  CIVIS Blended Intensive Programme, The science, ethics and governance of human genome editing, University of Tübingen, Germany, 27 July-31 July 2023  École d'été 2023 de la Chaire UNESCO Éthique, Science et Société Approches éthiques et juridiques de la vérité en science, 6-7 July 2023, Toulouse, France Workshops  Regulatory Science for Advanced (Gene and Cell) Therapies short courses, University College London, London, UK 07-08 Nov 2022  Meeting of the OUP Online Encyclopaedia of European Union Law: Evolving EU health law following the Covid-19 pandemic, Faculty of Law-Maynooth, Ireland, 23 June 2023 Seminars  Webinar 2: Regulatory possibilities to enhance cooperation among the EU's governance structures and complementarity within the EU acquis, EUHPP-EAHL IG, Webex, 10 January 2022  « L'accès aux médicaments est-il un droit ? », Chaire Santé de l'école de droit de SciencePo Paris, Zoom, 16 February 2022  Webinar 3 : Political and legal issues linked to financing the development of pharmaceuticals all along their life-cycle, EUHPP -EAHL IG, Webex, 3 Mars 2022  « Politique du médicament en France et en Europe », Académie Nationale de Pharmacie, 9 Mars 2022  Innovation for Good: a Global Technology Governance Perspective, Professor David Winickoff, OECD Organisation for Economic Co-operation and Development), Law and Technologies Webinar Series | Oxford Law Faculty, 1 June 2022  OUP Online Encyclopaedia seminar, The City Law School, London, UK, 10 June 2022  The new Regulation on Health Technology Assessment (HTA), European Commission Directorate, The City Law School, London, UK, 10 June 2022  The new Regulation on Health Technology Assessment (HTA), European Commission, Directorate-General for Health and Food Safety, Brussels, Belgium, 22 June 2022  European Infrastructure for Translational Medicine and European Medicines Agency European Commission Webinar on Support for Academic and Non-Profit ATMP Developers, 1 st December 2022  EU Health Governance Research Network Webinar EU Pharmaceutical Activity: Challenges arising from the Pharmaceutical Strategy and Beyond, 25 January 2023  GT 3M (Maladies rares, Mutation, Méditerranée) Séminaire interdisciplinaire essais cliniques, Marseille, France, 13 April 2023  Online event TESaCo (technologies émergentes et sagesse collective) Biotechnologies : quelle sagesse collective ?, CRISPR-Cas9 Genome Editing, 11 May 2023  Online event TESaCo (technologies émergentes et sagesse collective) Biotechnologies : quelle sagesse collective ?, Novel forms of life: organoids, 22 May 2023  Webinars hosted by Alliance for Regenerative Medicine (ARM) :

	7. biostatistics Guidelines and points to consider on safety and efficacy: o EU Health Solidarity in Times of Crisis: Explaining Public Preferences Towards EuroGCT EU risk Pooling for Medicines, 12 May 2021:
	 EMA, CHMP, Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs), EMEA/CHMP/BWP/473191/2006, 11 December 2006, https://www.ema.europa.eu/en/environmental-risk-assessments-medicinal-products-containing-consisting-genetically-modified  EMA, CHMP, Guideline on clinical trials in small populations, E. https://estream.lancaster.ac.uk/GetMP4.ashx?ppID=2&file=39295_5p~Jcufba Annex 2.c to Deliverable D.4.7 KBgU.mp4&source=8&bb=0&bt=0&po=0&pi=0&ds=1802.4&so=31&st=0&tf=0 Notes for guidance 1. Notes for guidance specific to ATMPs List of attended Conferences, Workshops and Seminars &cs=plrbGhpmnoHiKN688zXSKL_VJkf5GNFoLB_jq8RPSB6NWGBqZrHIL_P uTZND2Gt17OKdIZCRd8rdvYdAtOh99g o What progress in achieving transparency in pharmaceutical regulation? 23 CHMP/One pivotal study, CPMP/EWP/2330/99, 31 May 2001, https://www.ema.europa.eu/en/application-1-meta-analyses-2-one-pivotal-study 8. ICH Guidelines on quality  EMA, CPMP, ICH Q2 (R1) Validation of analytical procedures: text and methodology, CPMP/ICH/381/95, June 1995, https://www.ema.europa.eu/en/ich-q2-r1-validation-analytical-procedures-text-methodology  EMA, CPMP, ICH Q5A (R1) Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, CPMP/ICH/295/95, October 1997, UNDER REVISION (10 October 2022), https://www.ema.europa.eu/en/ich-q5a-r1-quality-biotechnological-products-viral-safety-evaluation-biotechnology-products-derived  EMA, CPMP, ICH Q5C Stability testing of biotechnological/biological products, 2. Notes for guidance on Biologicals: drug product  EMA, Note for guidance on Development pharmaceutics for biotechnological and biological products, CPMP/BWP/328/99, 21 October 1999, 02/2021-01/2022 June 2021: https://estream.lancaster.ac.uk/GetMP4.ashx?ppID=2&file=40625_5e~WGhZ rLrYiH.mp4&source=8&bb=0&bt=0&po=0&pi=0&ds=2801.92&so=4&st=0&tf= 0&cs=rfM3HwtXN5sC95DHC10p6a59s8P1CAI6fgj7hCb4T70Ny35uOA55Ggo eQ1WSoKoZWFDs09kX7TjEdB0ryebkMA Conferences  02/2022 -07/2023 https://www.ema.europa.eu/en/development-pharmaceutics-biotechnological- EAHL Conference 2022, Ghent, Belgium, 20-22 April 2022 biological-products-annex-note-guidance-development  16th World Congress of Bioethics (WCB), « Bioethics post Covid-19: Responsibility  EMA, CPMP, Note for guidance on development pharmaceutics, CPMP/QWP/155/96, and transparency in a globalized and interconnected world » (including topics on new 28 January 1998, https://www.ema.europa.eu/en/development-pharmaceutics-technologies), International Association of Bioethics (IAB) hosted by the IBMB, Basel, scientific-guideline Switzerland, 20-22 July 2022.  EMA, Note for guidance on minimising the risk of transmitting animal spongiform  2022 International Mammalian Synthetic Biology Biology Workshop (mSBW) encephalopathy agents via human and veterinary medicinal products, EMA/410/01 Edinburgh, UK, 28-29 July 2022 Rev. 3, 5 March 2011, https://www.ema.europa.eu/en/minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-veterinary-medicinal 
	 EMA, CHMP, Guideline on the use of bovine serum in the manufacture of human CPMP/ICH/138/95, July 1996, https://www.ema.europa.eu/en/ich-q5c-stability-testing-
	biological medicinal products, EMA/CHMP/BWP/457920/2012 rev 1, 30 May 2013, biotechnologicalbiological-products
	https://www.ema.europa.eu/en/use-bovine-serum-manufacture-human-biological- EMA, CPMP, ICH Q5D Derivation and characterisation of cell substrates used for
	medicinal-products production of biotechnological/biological products, CPMP/ICH/294/95, March 1998, F. Procedural advices
	 EMA, CHMP, Guideline on the use of porcine trypsin used in the manufacture of https://www.ema.europa.eu/en/ich-q5d-derivation-characterisation-cell-substrates-
	human biological medicinal products, EMA/CHMP/BWP/814397/2011, 20 February 2014, https://www.ema.europa.eu/en/use-porcine-trypsin-used-manufacture-human-used-production-biotechnologicalbiological  EMA, CPMP, ICH Q5E Comparability of biotechnological/biological products, 1. Specific to ATMPs
	biological-medicinal-products CPMP/ICH/5721/03, June	2005,	https://www.ema.europa.eu/en/ich-q5e-
	biotechnologicalbiological-products-subject-changes-their-manufacturing-process
	 EMA, CPMP, ICH Q6B Specifications: Test procedures and acceptance criteria for
	biotechnological/biological	products,	CPMP/ICH/365/96,	September	1999,
	https://www.ema.europa.eu/en/ich-q6b-specifications-test-procedures-acceptance-
	criteria-biotechnologicalbiological-products
	 EMA, CPMP, ICH Q7 Good manufacturing practice for active pharmaceutical
	ingredients, CPMP/ICH/4106/00, November 2000, https://www.ema.europa.eu/en/ich-
	q7-good-manufacturing-practice-active-pharmaceutical-ingredients
	 EMA, CHMP, ICH Q8 (R2) Pharmaceutical development, CHMP/ICH/167068/04, 22 June 2017, https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development  EMA, CHMP, ICH guideline Q9 (R1) on quality risk management -Step 5, EMA/CHMP/ICH/24235/2006, 3 February 2023, https://www.ema.europa.eu/en/ich-q9-quality-risk-management  EMA, CHMP, ICH Q10 Pharmaceutical quality system, EMA/CHMP/ICH/214732/2007, September 2015, https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system 9. ICH Guidelines on Efficacy Workshops  Hosted by the ATMP PPIE Working Group (co-led by NHS England and NHS Improvement and Genetic Alliance UK): o ATMP Patient Facing Information Discovery Workshops o Histology Independent Therapies Workshops:  Exploring patient and public information needs  Resource co-production Research Agenda, 28 April 2021: https://estream.lancaster.ac.uk/GetMP4.ashx?ppID=2&file=38941_5m~f0ABX jcsPc.mp4&source=8&bb=0&bt=0&po=0&pi=0&ds=1471.23&so=4&st=0&tf=0 &cs=717DPRRigK~0LnJg~Uy26g1npQWv1yj0BF7eWC7DujvUCB0aBh1FJP VHX10WWdpSyX~qDOCGtJeh~18uFJncww o The use of EU soft law in the making of domestic eHealth policies: from Electronic Health Records to Covid-19 contact tracing applications, 5 May 2021: https://estream.lancaster.ac.uk/GetMP4.ashx?ppID=2&file=38940_5l~EpkZm  A 8Sira.mp4&source=8&bb=0&bt=0&po=0&pi=0&ds=1756.29&so=4&st=0&tf=0
	&cs=Qdq18rsmy7TLpNi_6oCA3q8H6lT9nq9SEzPlCdSUIcT35QtuT2noV8JrJ
	oYQHszt_RN_KrcU4IuFM7OvD548sg

CPMPo Regulatory & Clinical Aspects of ATMPs o EMA and EATRIS, Navigating the Regulatory Requirements for ATMPs, 29 November 2021: https://eatris.eu/events/ema-and-eatris-present-navigatingthe-regulatory-requirements-for-atmps/  Public Dialogue on Genome Editing in Life Sciences Research (ORION presentation of findings)  From CRISPR to COVID: Communicating science in an age of moral dilemmas, uncertain science, and polarized politics (University of Edinburgh)  Gene therapies for rare diseases -how to make this a success story in Europe? (Alliance for Regenerative Medicine)  Socialising the Genome: Genomics, Public Trust and Engagement (Public Policy Projects)  RESTORE -Health by Advanced Therapies Gene Therapy 2.0, 29 September 2021: https://www.restore-horizon.eu/gene-therapy-2-webinar/  Launch of the UKAT and Challenges in clinical trials in Advanced Therapies (UK Advanced Therapies Network)  ATMP Roadmap launch (ABPI & AAC)  Hosted by GRP Health in Europe: o The Future of EU Health Law and Policy (Health Economics, Policy and Law Special Issue), 14 April 2021, link to publication: https://www-cambridgeorg.lama.univ-amu.fr/core/journals/health-economics-policy-andlaw/issue/39EFAF9B49AC3C13203740DBB289DA12 o o Données patients & Blockchain, 22 June 2021 o La bio-informatique de qualité réglementaire au service du développement des Médicaments de thérapie innovante, 8 July 2021  Hosted by Bayer Pharmaceuticals, Regenerative medicines: How cell gene therapies may defeat incurable diseases one day, 24 June 2021  Hosted by Société Française de Thérapie Génique et Cellulaire, Thérapie génique pour la maladie de Wilson : des challenges scientifiques à la translation clinique, 1 er October 2021 : https://www.youtube.com/channel/UCaXNMgvGLRq4O3Oj29H7dew  Hosted by Nile: o Thérapies géniques, 8-9 June 2021 : https://www.nile-consulting.eu/portfolioitem/livre-dactes-pour-lacces-des-malades-aux-therapies-geniques/ o Table ronde n°1 : Renforcer la politique européenne en faveur des maladies rares, 20 October 2021 : https://www.nile-consulting.eu/portfolio-item/colloqueeurope-de-la-sante/ o Table ronde n°2 : Le déploiement en Europe du concept « One Health », 21 October 2021 : https://www.nile-consulting.eu/portfolio-item/colloque-europede-la-sante/ o European Union Health Policy Platform, 2021 Thematic Network on « Health as fundamental value: Towards an equitable and inclusive pharmaceutical strategy for the EU", 22 November 2021 o "

 EMA, CAT, Design modifications of gene therapy medicinal products during development, EMA/CAT/GTWP/44236/2009, 14 December 2011,

The European Consortium for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use WP: Work Package GA: Grant Agreement Deliverable 4.

collated rather than summarising the collated information itself. collated information is presented in the EuroGCT website Research Pathways section (https://www.eurogct.org/research

A. Guidelines

 CPMP, Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells, 3AB6a, December 1994, https://www.ema.europa.eu/en/gene-therapy-product-quality-aspects-productionvectors-genetically-modified-somatic-cells Reflection papers Structure for creating lay summaries of Social and Human Sciences research papers

The relative word counts for each section are given as a guide and may change depending on the emphasis of the study. The key is to keep it short.

Title

A simple, clear title, which will usually involve changing the paper's title.

Summary (Maximum 120 words)

Gives a clear overview of the study and is stand-alone from the rest of the text (some may only read the summary). Include why the study was done, what was found and the implications. You could use bullet points.

3. What is the scope of the paper? (Maximum 120 words) Which country/ies is/are covered? What is the scientific discipline of this paper (law, sociology, STS, interdisciplinary…)? What is the object covered this paper (advanced therapy, blood, CAR-T cells…)?

4. What are the key aspects of the paper? (Maximum 500 words) Details the main ideas of the paper going a step further than what is said in 2. You could use bullet points.

What is the layout of the paper?

Provides the table of contents of the paper, its titles and subtitles showing how the author has framed the paper.

Further information and links

Link to scientific abstract and the full article if available. Also include any relevant other material which could include papers and information sites. Template for creating lay summaries of guidelines

The relative word counts for each section are given as a guide and may change depending on the emphasis of the guideline and whether its scope is basic, translational or clinical. The key is to keep it short.

1. Title

Summary (Maximum 120 words)

Gives a clear overview of the guideline and is stand-alone from the rest of the text (some may only read the summary). Include why the guideline was done, what was proposed and the implications. You could use bullet points.

What is the idea behind this guideline? (Maximum 150 words)

Why was this guideline done? Give any relevant background to the guideline, including previous guideline, guidelines from other parts of the world, guidelines on similar topics, and relate to any relevant conditions.

What is the scope of this guideline? (Maximum 150 words)

What is the field of application of this guideline (therapy, indication, pathology, legal classification of products)?