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
Published14/05/2011
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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