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

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/QWP/185401/2004
Published31/03/2006
Effective from01/10/2006
KeywordsClinical trial, quality
DescriptionThis 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.


Document history

Revision 1 

In progress

Draft guidelines



Concept paper

Published: 12/04/2006

Deadline for comments: 12/10/2016


Published: 30/03/2015

First version

Current version

Adopted guideline

In operation: 01/10/2006–present


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