European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs
The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.
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Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.
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.
The finalization of the EU GMP guideline for advanced therapy medicinal products has been pushed back as the European Commission is trying to address concerns raised by a group representing the world's leading pharmaceutical inspectorates. While the industry is disappointed with the delay, it supports the Commission’s efforts to secure consensus on this key guideline.