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

Current effective version

PDF iconAdopted guideline

Reference numberEMEA/CHMP/BMWP/101695/2006
Published19/07/2007
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

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/11/2007–present


Published: 24/01/2007


Published: 22/02/2006

Superseded document


PDF iconAdopted guideline


PDF iconConcept paper

In operation: 01/06/2004–31/10/2007


Published: 24/06/1998


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