Commission Defends GMP Guide For ATMPs As PIC/S Cautions Against Divergence

Regulatory authorities participating in the international Pharmaceutical Inspection Co-operation Scheme are concerned that the European Commission’s proposed good manufacturing practice guideline on advanced therapy medicinal products diverges from PIC/S requirements and will result in lower regulatory standards. The commission defends its approach, saying the guideline will result in high-quality ATMPs and ensure patient protection.