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 modifie...