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EU Issues GMP Guide For Investigational Drugs Under Clinical Trials Regulation

 
• By Vibha Sharma

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.

GMP
EU Guide Addresses Manufacturing Of Investigational Drugs • Source: Shutterstock

The European Commission has adopted a detailed guideline on good manufacturing practice (GMP) requirements for investigational medicinal products under the upcoming EU Clinical Trials Regulation.

The guideline applies to the manufacturing and import of investigational drugs for human use, and will come into effect when...

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