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European Commission Finally Delivers On GMP Standards For ATMPs

 
• By Vibha Sharma

Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.

GMP
Finalization Of EU GMP Guide For ATMPs Is An Important Step Forward • Source: Shutterstock

The European Commission has at last finalized the long-awaited guideline on good manufacturing practice (GMP) requirements for innovative cell, gene and tissue therapies - also referred to as advanced therapy medicinal products (ATMPs).

The publication of the final guideline was put on hold for nearly a year after the commission and various stakeholders...

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