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 from April until the end of June 2024. All interested parties are encouraged to review it and submit their comments.

For more information on how to comment, please consult our “How to comment” guide. Comments from states parties to the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

See also:

• European Pharmacopoeia
• European Pharmacopoeia Commission
• EDQM Knowledge Database