Not There Yet: Concerns Persist On Appropriate Format Of EU GMP Guide For ATMPs
After holding two rounds of public consultation on its proposals for good manufacturing practice requirements for advanced therapy medicinal products, the European Commission has still not been able to address stakeholder concerns regarding the appropriate format of this eagerly-awaited draft guideline.
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The European Medicines Agency must be informed about each 'out of specification' batch of a cell or tissue-based advanced therapy that has been granted marketing authorization. The agency warns that if a trend is discovered, it may consider the need for regulatory actions.
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.
EU biopharmaceutical industry group EBE says it is awaiting keenly the publication of good manufacturing practice guide for advanced therapy medicinal products, after learning that the European Commission is making changes to address concerns it had over the appropriate format of the document.