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

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Current effective version

First version - Adopted guideline

Currently under revision - see below

Reference numberEMEA/CHMP/BWP/534898/08
Effective from15/04/2012
KeywordsBiological product, investigational medicinal product (IMP), clinical trial, quality
DescriptionThis 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.

Document history

Revision 1

In progress

Adopted guideline

Overview of comments

Draft guideline

Draft guideline: document with track changes

Published: 26/10/2017
Effective from: 26/04/2018

Published: 26/10/2017

Published: 01/07/2016

Published: 01/07/2016

First version

Current version

Adopted guideline

Draft guideline

Concept paper

In operation: 15/04/2012–present

Published: 11/03/2010

Published: 21/02/2008

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