EU Issues GMP Guide For Investigational Drugs Under Clinical Trials Regulation
A new EU guideline explains how manufacturers and importers of investigational medicinal products can comply with the provisions of a 2017 delegated regulation specifying good manufacturing practice requirements and inspection procedures for such products.
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The European Medicines Agency has issued a draft guideline to support the upcoming Clinical Trials Regulation, explaining how investigational medicinal products should be handled before they are sent to clinical trial sites.
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.
With the implementation of the EU Clinical Trials Regulation now postponed to the second half of 2019, it is unlikely that its provisions will be taken over into UK legislation as part of the Brexit “Repeal Bill” that will convert all EU laws and regulations into domestic UK law.