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European Directorate for the Quality of Medicines (EDQM) – New European Pharmacopoeia Commission approach to gene therapy (Catapult’s regulatory round-up – May 2024)

At its 178th session held in March 2024, the European Pharmacopoeia Commission EPC adopted the general monograph Gene therapy medicinal products for human use (1386) and the accompanying general chapter Additional information on gene therapy medicinal products for human use (5.34), which will replace general chapter 5.14.

In addition to a general requirements section containing provisions on the production of all GTMPs and specific requirements for recombinant vectors and genetically modified cells for human use, general monograph 3186 contains three individual sections describing additional requirements for the classes of GTMPs currently approved in Europe:

  • genetically modified human autologous cells modified by integrating retroviral or lentiviral vectors;
  • adeno-associated virus vectors for human use;
  • oncolytic herpes simplex virus for human use

The accompanying general chapter 5.34 includes recommendations on product classes that are not yet on the European market to assist users and contains:

  • the revised remaining sections of chapter 5.14, covering:
  • plasmid vectors for human use;
  • adenovirus vectors for human use;
  • poxvirus vectors for human use;
  • retroviridae-derived vectors for human use.
  • a newly drafted section on genetically modified bacterial cells for human use.

In addition, general chapter 5.2.12. Raw material of biological origin for the production of cell-based and gene therapy medicinal products has also been revised to align it with this new approach. Please find further information here.

Published on the 5th of June in Catapult’s regulatory round-up for May 2024.

 

 


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (4 novembre 2024). European Directorate for the Quality of Medicines (EDQM) – New European Pharmacopoeia Commission approach to gene therapy (Catapult’s regulatory round-up – May 2024). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/12m71


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