Draft concept paper on the need for revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

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Download document Draft concept paper on the need for revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
Reference number EMA/CHMP/QWP/126334/2015
Status draft: consultation closed
First published 2015-03-30
Last updated 2015-03-30

Summary

This concept paper addresses the need to update and revise the CHMP/QWP/185401/2004 final guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. This guideline was originally adopted on 23rd March 2006 and came into operation on 1st October 2006.