Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/BMWP/101695/2006
Effective from01/11/2007
KeywordsComparability testing, changes in manufacturing procedure, non-clinical, efficacy, pharmacovigilance
DescriptionThis document gives advice on the non-clinical and clinical requirements of the comparability exercise comparing post-change product to pre-change product where manufacturing process changes are made by a single manufacturer, including those made by a contract manufacture. It addresses the requirements for non-clinical and/or clinical bridging studies to demonstrate that the manufacturing change has no impact on safety and efficacy.

Document history

First version

Current version

Adopted guideline

Draft guideline

Concept paper

In operation: 01/11/2007–present

Published: 24/01/2007

Published: 22/02/2006

Superseded document


Adopted guideline

Concept paper

In operation: 01/06/2004–31/10/2007

Published: 24/06/1998

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