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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 could not reach consensus on the format of the final document, even after engaging in two rounds of targeted consultations in 2015 and 2016

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