Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

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Current effective version

Adopted guideline - Revision 1

Reference numberEMA/CHMP/QWP/545525/2017
Effective from28/05/2018
KeywordsClinical trial, quality

This document addresses the documentation on the chemical and pharmaceutical quality of investigational medicinal product dossier containing chemically defined drug substances, synthetic peptides, herbal substances, herbal preparations and chemically defined radio-active/radio-labelled substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans.


Please note that requirements related to the Clinical Trial Regulation will apply only on enty into application of the Regulation. Scientific requirements apply from 28 May 2018.

Document history

Revision 1 

Current version

Adopted guideline

Overview of comments

Draft guidelines

Concept paper

In operation: 28/05/2018-present

Published: 28/11/2017

Published: 12/04/2006

Published: 30/03/2015

First version

Adopted guideline

Published: 31/03/2006

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