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Commission Delays EU GMP Guide For Advanced Therapies To Address Inspectorates’ Concerns

 
• By Vibha Sharma

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.

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European Commission Is Trying To Resolve Concerns About Its GMP Guide For ATMPs • Source: Shutterstock

The European Commission says it has made “good progress” on resolving concerns raised by regulatory authorities participating in the international Pharmaceutical Inspection Co-operation Scheme (PIC/S), and some other stakeholders, about its draft guideline on good manufacturing practice requirements for advanced therapy medicinal products (ATMPs).

The guideline – which is eagerly awaited by the pharmaceutical industry – was initially due to be finalized on April 26, but the Commission did not go ahead with this as it is “committed to addressing all views and concerns before

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