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European Commission Consults On New Clinical Trial Inspection And GMP Rules

This article was originally published in SRA

Executive Summary

The European Commission is in the early stages of drafting legislation that will describe in detail how inspections of clinical trials are to be conducted in the EU and elsewhere once the provisions of the new clinical trials legislation kick in around mid-2016. It is also drafting new guidance on the manufacture of investigational medicinal products (IMPs) used in clinical trials.

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