Commission Delays EU GMP Guide For Advanced Therapies To Address Inspectorates’ Concerns
The finalization of the EU GMP guideline for advanced therapy medicinal products has been pushed back as the European Commission is trying to address concerns raised by a group representing the world's leading pharmaceutical inspectorates. While the industry is disappointed with the delay, it supports the Commission’s efforts to secure consensus on this key guideline.
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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.
An action plan produced by the European Medicines Agency and the European Commission has put forward a number of ideas for streamlining the processes for developing and assessing advanced therapy medicines, with the aim of speeding up the current sluggish rate of ATMP approvals. Industry says it will assess the proposals to see how well they address the key issues worrying the sector.
Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.