Requirements for quality documentation concerning biological investigational medicinal products in clinical trials

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMA/CHMP/BWP/534898/2008 Rev. 1


Effective from26/04/2018
KeywordsBiological product, investigational medicinal product (IMP), clinical trial, quality

This document addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. It applies to cases where no 'simplified IMP Dossier' is submitted.


Please note that requirements related to the Clinical Trial Regulation will apply only on enty into application of the Regulation. Scientific requirements apply from 26 April 2018.

Document history

Revision 1

Current version

Adopted guideline


Overview of comments

Draft guideline

Draft guideline: document with track changes

Published: 26/10/2017
In operation: 26/04/2018-present

Published: 26/10/2017

Published: 01/07/2016

Published: 01/07/2016

First version

Adopted guideline

Draft guideline

Concept paper

In operation: 15/04/2012-26/04/2018

Published: 11/03/2010

Published: 21/02/2008

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