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.
You may also be interested in...
A targeted stakeholder consultation will soon be launched on proposals to split the Pharmaceutical Inspection Co-operation Scheme's existing guide on biological products into two parts so as to focus separately on manufacturing issues specific to gene therapy and tissue-engineered products.
Pharmaceutical inspectorates around the world are trying to address the divergences between Europe’s good manufacturing practice guideline on gene therapy and tissue-engineered products and the international GMP guideline for such products.
Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.