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

  • Email
  • Help
Current effective version

Revision 1 - Adopted guideline

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

26/10/2017

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

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


Related content


How helpful is this page?

Average rating:

 Based on 31 ratings

Add your rating:

See all ratings
7 ratings
6 ratings
6 ratings
6 ratings
6 ratings
    

Tell us more