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Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products.
Adv Exp Med Biol. 2015; 871:73-85.AE

Abstract

Advanced therapy medicinal products, a new class of products with promising therapeutic effects, have been classified as medicinal products and as such should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved through clinical trials, which have also to be approved according to a well-established regulatory process, prior any initiation. This chapter is dedicated to describe the regulatory pathway to be followed in France, before initiating any clinical trial with those investigational advanced therapy medicinal products. In France, to get the final authorisation to initiate a clinical trial, the legislation imposes to run in parallel two independent but complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a genetically modified organism. The French system herein described is in line with the EU regulation on clinical trial and follows the respective deadlines for granting the final approval. The complexity of the procedure is in fact more due to the complexity of the products and protocols to be assessed than to the procedure itself which is now very close to the well-known procedure applied routinely for more conventional chemical or biological candidate medicinal products.

Authors+Show Affiliations

BIOVAC Directorate, National Safety Agency for Drug and Health Products, Management of Organic Products, Saint Denis, France. sophie.lucas-samuel@ansm.sante.fr.BIOVAC Directorate, National Safety Agency for Drug and Health Products, Management of Organic Products, Saint Denis, France. Nicolas.ferry@ansm.sante.fr. Committee for Advanced Therapies (CAT), European Medicines Agency, London, UK. Nicolas.ferry@ansm.sante.fr.Public Health and Health Products, School of Pharmacy, Paris-Descartes University, Paris, France. jean-hugues.trouvin@parisdescartes.fr.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374213

Citation

Lucas-Samuel, Sophie, et al. "Overview of the Regulatory Oversight Implemented By the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 73-85.
Lucas-Samuel S, Ferry N, Trouvin JH. Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products. Adv Exp Med Biol. 2015;871:73-85.
Lucas-Samuel, S., Ferry, N., & Trouvin, J. H. (2015). Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products. Advances in Experimental Medicine and Biology, 871, 73-85. https://doi.org/10.1007/978-3-319-18618-4_4
Lucas-Samuel S, Ferry N, Trouvin JH. Overview of the Regulatory Oversight Implemented By the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products. Adv Exp Med Biol. 2015;871:73-85. PubMed PMID: 26374213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products. AU - Lucas-Samuel,Sophie, AU - Ferry,Nicolas, AU - Trouvin,Jean-Hugues, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Advance therapy medicinal product KW - Application dossier KW - Clinical trial KW - French regulation KW - Investigational medicinal product SP - 73 EP - 85 JF - Advances in experimental medicine and biology JO - Adv. Exp. Med. Biol. VL - 871 N2 - Advanced therapy medicinal products, a new class of products with promising therapeutic effects, have been classified as medicinal products and as such should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved through clinical trials, which have also to be approved according to a well-established regulatory process, prior any initiation. This chapter is dedicated to describe the regulatory pathway to be followed in France, before initiating any clinical trial with those investigational advanced therapy medicinal products. In France, to get the final authorisation to initiate a clinical trial, the legislation imposes to run in parallel two independent but complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a genetically modified organism. The French system herein described is in line with the EU regulation on clinical trial and follows the respective deadlines for granting the final approval. The complexity of the procedure is in fact more due to the complexity of the products and protocols to be assessed than to the procedure itself which is now very close to the well-known procedure applied routinely for more conventional chemical or biological candidate medicinal products. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374213/Overview_of_the_Regulatory_Oversight_Implemented_by_the_French_Regulatory_Authorities_for_the_Clinical_Investigation_of_Gene_Therapy_and_Cell_Therapy_Products_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_4 DB - PRIME DP - Unbound Medicine ER -