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European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs

 
• By Bowman Cox

The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.

The European Commission has signaled a willingness to discuss the separate, less stringent GMP guidelines for advanced therapy medicinal products that it has proposed over the objections of inspectorates and pharmaceutical industry groups in Europe and around the world.

Even though the consultation process for the draft guideline is over, the commission's director general for health and food security,...

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