EDQM – Public consultation on a new general chapter on cell-based preparations for human use in Pharmeuropa 36.2 (Catapult’s regulatory round-up – May 2024)
In response to the need for a text covering the quality of cell-based preparations in the rapidly evolving field of advanced therapy medicinal products, the European Pharmacopoeia Commission is proposing a new general chapter, “Cell-based preparations for human use” (5.32), to its stakeholders. The chapter provides a framework of requirements for the production and control of cell-based preparations and comprises a definition, an extensive set of general requirements common to all cell-based preparations followed by four detailed individual sections describing additional specific requirements (for human haematopoietic stem/progenitor cells, human chondrocytes, human limbal stem cells and human mesenchymal stromal cells, respectively).
The draft general chapter has now been published in Pharmeuropa 36.2, where it will remain open for public consultation until 30 June 2024.
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). EDQM – Public consultation on a new general chapter on cell-based preparations for human use in Pharmeuropa 36.2 (Catapult’s regulatory round-up – May 2024). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/12m72





