Concerns Over Format Of EU GMP Guideline For ATMPs Finally Resolved; Publication Due
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.
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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 biotech companies have welcomed the various initiatives that the European Medicines Agency has listed to support the development of advanced therapy medicinal products. However, they want clear timelines on completing these initiatives since their implementation will not require any changes to the current legislative framework.
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.