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[Poster] The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools

Abstract

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 2007. 

Any company wishing to manufacture ATMPs in the EU must hold a manufacturing authorisation issued by the national competent authority of the Member State where they carry out these activities. 

Ensuring the quality of medicines is a criterion to obtain ATMPs’ marketing authorisation issued by the European Commission under the “centralised procedure” after a single application to the European Medicines Agency. All ATMPs marketed in the EU must be produced in accordance with EU quality standards to ensure the quality, safety and efficacy of medicines for the patients: Good Manufacturing Practice (GMP) principles and guidelines dedicated to ATMPs enforceable since 2017, and relevant parts of the European Pharmacopeia provide the main regulatory standards to comply with. 

The manufacture, meeting the GMP requirements from the raw materials to the final product, is particularly challenging for ATMPs regarding their level of complexity and their specific characteristics, especially the use of substances of human origin as starting materials, and the reproducibility when using live biological samplesThe ATMPs’ manufacturer has to maintain costly technical specifications capable of guaranteeing the reproducibility of the medicine’s composition in accordance with GMP guidelines and the specific requirements of the ATMP marketing authorisation.

Regulatory requirements are often seen as obstacles to the development of ATMPs. Nevertheless, they mainly provide a set of solutions to overpass the technical obstacles of ATMPs’ manufacturing in order to ensure their quality for the safety of patients. It appears clearly within the various supporting regulatory tools currently available at the European level, which include both guidance documents and procedures for interactions with regulators.

This poster will provide an overview of the challenges of ATMPs’ manufacturing and link them to the relevant supporting regulatory tools highlighting both their strengths and their limits in the context of ATMPs development for patients.

 

Poster

poster: The challenges of Advanced Therapy Medicinal Products manufacturing in the European Union: Strengths and limits of current regulatory tools

The pdf file of this poster can be downloaded from the attachment section at the bottom of this page.

 

Authors

Luc-Sylvain GilbertEuroGCT Information Officer on Ethical, Legal & Societal issues, Research Engineer in law, Law Faculty, UMR 7318 International, Comparative and European laws (DICE) CERIC, CNRS, Aix Marseille University, Toulon University, Pau & Pays de l’Adour University, Aix-en-Provence, France.

Auxane Delage EuroGCT Information Officer on Ethical, Legal & Societal issues, Research Engineer and PhD student in law, Law Faculty, UMR 7318 International, Comparative and European laws (DICE) CERIC, CNRS, Aix Marseille University, Toulon University, Pau & Pays de l’Adour University, Aix-en-Provence, France. 

Aurélie Mahalatchimy, EuroGCT Deputy coordinator and WP4 leader; Permanent Researcher in law at the French National Centre for Scientific Research (CNRS, chargée de recherche), Law Faculty, UMR 7318 International, Comparative and European laws (DICE) CERIC, CNRS, Aix Marseille University, Toulon University, Pau & Pays de l’Adour University, Aix-en-Provence, France.

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