European Directorate for the Quality of Medicines (EDQM) - New European Pharmacopoeia Commission approach to gene therapy (Catapult's regulatory round-up - May 2024)
Year: 2024
Type: other
Abstract: 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...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12m71
Author: Adelage
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6937038236
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