The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union
Advanced Therapy Medicinal Products (ATMPs) is a European classification of medicinal products based on genes, cells and tissues specifically regulated in the European Union (EU) from the entry into force of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 20...
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2023
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ftunivpau:oai:HAL:halshs-04290539v1 2023-12-31T10:08:23+01:00 The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union Mahalatchimy, Aurélie Gilbert, Luc-Sylvain Delage, Auxane Nègre, Olivier Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC) (DICE / CERIC) Droits International, Comparé et Européen (DICE) Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS) International Society for Cell & Gene Therapy ANR-20-CE26-0007,I-BioLex,Fragmentation et défragmentation du droit des innovations biomédicales(2020) European Project: 965241,EuroGCT Paris Palais des congrès, France 2023-05-31 https://shs.hal.science/halshs-04290539 https://shs.hal.science/halshs-04290539/document https://shs.hal.science/halshs-04290539/file/Poster%20-%20ISCT%202023%20PARIS%20The%20marketing%20authorisation%20of%20advanced%20therapy%20medicinal%20product%20FINAL.pdf en eng HAL CCSD info:eu-repo/grantAgreement//965241/EU/European Consortium for Communicating Gene and Cell Therapy Information/EuroGCT halshs-04290539 https://shs.hal.science/halshs-04290539 https://shs.hal.science/halshs-04290539/document https://shs.hal.science/halshs-04290539/file/Poster%20-%20ISCT%202023%20PARIS%20The%20marketing%20authorisation%20of%20advanced%20therapy%20medicinal%20product%20FINAL.pdf info:eu-repo/semantics/OpenAccess International Society for Cell & Gene Therapy 2023 Annual Meeting https://shs.hal.science/halshs-04290539 International Society for Cell & Gene Therapy 2023 Annual Meeting, May 2023, Paris Palais des congrès, France. Abstract published in Cytotherapy, 25 (6 Supplement), pp.S160-S161, 2023 [SHS]Humanities and Social Sciences [SHS.DROIT]Humanities and Social Sciences/Law info:eu-repo/semantics/conferenceObject Conference poster 2023 ftunivpau 2023-12-06T17:24:39Z Advanced Therapy Medicinal Products (ATMPs) is a European classification of medicinal products based on genes, cells and tissues specifically regulated in the European Union (EU) from the entry into force of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on ATMPs. Any company wishing to market ATMPs within the EU must hold a Marketing Authorisation (MA) issued by the European Commission under the “centralised procedure”, after a single application to the European Medicines Agency (EMA) and its scientific assessment by the Committee for Advanced Therapies. The purpose of the MA is to ensure high quality, safety and efficacy for ATMPs, with a positive risk-benefit balance, to be commercialised. The MA is valid in the EU Member States, Iceland, Norway and Liechtenstein for a five-years period.From the adoption of the EU regulation, 24 ATMPs have been granted a marketing authorisation in the EU and the European Commission decision is pending for another one. There has been a clear increase in approvals from 2018, and most approved ATMPs are gene therapy medicinal products. Almost half of them benefited from expediting pathways or regulatory support schemes for (innovative) medicines to be commercialised in the EU. Nevertheless, MA has been withdrawn or not renewed for 7 of them. This poster will present the European regulatory requirements and pathways for ATMPs to obtain marketing authorisation, and discuss the challenges of their commercialisation. Conference Object Iceland HAL e2s UPPA (Université de Pau et des Pays de l'Adour) |
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HAL e2s UPPA (Université de Pau et des Pays de l'Adour) |
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ftunivpau |
language |
English |
topic |
[SHS]Humanities and Social Sciences [SHS.DROIT]Humanities and Social Sciences/Law |
spellingShingle |
[SHS]Humanities and Social Sciences [SHS.DROIT]Humanities and Social Sciences/Law Mahalatchimy, Aurélie Gilbert, Luc-Sylvain Delage, Auxane Nègre, Olivier The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union |
topic_facet |
[SHS]Humanities and Social Sciences [SHS.DROIT]Humanities and Social Sciences/Law |
description |
Advanced Therapy Medicinal Products (ATMPs) is a European classification of medicinal products based on genes, cells and tissues specifically regulated in the European Union (EU) from the entry into force of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on ATMPs. Any company wishing to market ATMPs within the EU must hold a Marketing Authorisation (MA) issued by the European Commission under the “centralised procedure”, after a single application to the European Medicines Agency (EMA) and its scientific assessment by the Committee for Advanced Therapies. The purpose of the MA is to ensure high quality, safety and efficacy for ATMPs, with a positive risk-benefit balance, to be commercialised. The MA is valid in the EU Member States, Iceland, Norway and Liechtenstein for a five-years period.From the adoption of the EU regulation, 24 ATMPs have been granted a marketing authorisation in the EU and the European Commission decision is pending for another one. There has been a clear increase in approvals from 2018, and most approved ATMPs are gene therapy medicinal products. Almost half of them benefited from expediting pathways or regulatory support schemes for (innovative) medicines to be commercialised in the EU. Nevertheless, MA has been withdrawn or not renewed for 7 of them. This poster will present the European regulatory requirements and pathways for ATMPs to obtain marketing authorisation, and discuss the challenges of their commercialisation. |
author2 |
Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC) (DICE / CERIC) Droits International, Comparé et Européen (DICE) Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Université de Pau et des Pays de l'Adour (UPPA)-Université de Toulon (UTLN)-Centre National de la Recherche Scientifique (CNRS) International Society for Cell & Gene Therapy ANR-20-CE26-0007,I-BioLex,Fragmentation et défragmentation du droit des innovations biomédicales(2020) European Project: 965241,EuroGCT |
format |
Conference Object |
author |
Mahalatchimy, Aurélie Gilbert, Luc-Sylvain Delage, Auxane Nègre, Olivier |
author_facet |
Mahalatchimy, Aurélie Gilbert, Luc-Sylvain Delage, Auxane Nègre, Olivier |
author_sort |
Mahalatchimy, Aurélie |
title |
The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union |
title_short |
The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union |
title_full |
The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union |
title_fullStr |
The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union |
title_full_unstemmed |
The Marketing Authorisation of Advanced Therapy Medicinal Products under the regulation of the European Union |
title_sort |
marketing authorisation of advanced therapy medicinal products under the regulation of the european union |
publisher |
HAL CCSD |
publishDate |
2023 |
url |
https://shs.hal.science/halshs-04290539 https://shs.hal.science/halshs-04290539/document https://shs.hal.science/halshs-04290539/file/Poster%20-%20ISCT%202023%20PARIS%20The%20marketing%20authorisation%20of%20advanced%20therapy%20medicinal%20product%20FINAL.pdf |
op_coverage |
Paris Palais des congrès, France |
genre |
Iceland |
genre_facet |
Iceland |
op_source |
International Society for Cell & Gene Therapy 2023 Annual Meeting https://shs.hal.science/halshs-04290539 International Society for Cell & Gene Therapy 2023 Annual Meeting, May 2023, Paris Palais des congrès, France. Abstract published in Cytotherapy, 25 (6 Supplement), pp.S160-S161, 2023 |
op_relation |
info:eu-repo/grantAgreement//965241/EU/European Consortium for Communicating Gene and Cell Therapy Information/EuroGCT halshs-04290539 https://shs.hal.science/halshs-04290539 https://shs.hal.science/halshs-04290539/document https://shs.hal.science/halshs-04290539/file/Poster%20-%20ISCT%202023%20PARIS%20The%20marketing%20authorisation%20of%20advanced%20therapy%20medicinal%20product%20FINAL.pdf |
op_rights |
info:eu-repo/semantics/OpenAccess |
_version_ |
1786841091443523584 |