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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.

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Proposed EU GMP Guide On ATMPs Could Result in Divergence From PIC/S Standards • Source: Shutterstock

The European Commission’s approach to framing good manufacturing practice guidance for advanced therapy medicinal products has again come under fire, this time from the governing body of the international Pharmaceutical Inspection Co-operation Scheme, the PIC/S committee, which says the guideline could “add barriers” in the field of GMP for ATMPs and make harmonization efforts “more difficult.”

The new guideline is expected to be published in the first half of 2017. The issue raised by PIC/S concerns the fact that the commission is insisting on...

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