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...