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PIC/S Finds A Way To Solve Divergences With EU ATMP Guide

 
• By Vibha Sharma

A targeted stakeholder consultation will soon be launched on proposals to split the Pharmaceutical Inspection Co-operation Scheme's existing guide on biological products into two parts so as to focus separately on manufacturing issues specific to gene therapy and tissue-engineered products.

GMP
PIC/S Proposal Addresses Concerns Regarding EU GMP Guide On ATMPs • Source: Shutterstock

A way forward has been found to resolve the differences between the EU's controversial guideline on good manufacturing practices for advanced therapies and the international guideline of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on the same topic.

A PIC/S working group that was convened last year to look into this matter, along with representatives of the World Health Organization, has suggested that the divergences between the two...

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