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EU Close To Finalizing Revised GMP And Inspection Rules For Clinical Trials

 
• By Vibha Sharma

The European Commission has issued revised delegated legislation explaining new GMP requirements and inspection arrangements for investigational medicinal products that will come into play when the EU Clinical Trials Regulation kicks in.

The European Commission is inviting feedback on revised versions of proposed legislation specifying good manufacturing practice (GMP) requirements for investigational medicinal products and related inspection procedures that will apply when the provisions of the EU Clinical Trials Regulation come into effect in 2018. Feedback is also being sought on revisions to separate draft legislation on GMP requirements that will apply to finished medicinal products.

The proposed laws comprise a delegated regulation and an annex on GMP of investigational medicinal products (IMPs) and related inspection arrangements, and a revised directive and an

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