Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/271475/2006 Rev.1
Effective from01/09/2016
KeywordsImmunotherapy, potency testing, cell-based products
DescriptionThis revsion is a technical update to reflect current best practice with regard to implementation of 3Rs approaches and it is not intended as a full revision of this guideline (only sections 1, 4.1 and 4.2 are affected). In addition, minor changes have been introduced to reflect the new Agency templates, for example addition of an Executive Summary. All these changes are considered to be minor and uncontroversial and consequently a consultation phase was considered to be unnecessary.

Document history

Revision 1

Current version

Adopted guidelinePublished: 04/08/2016
Effective from: 01/09/2016

First version


Adopted guideline

Overview of comments

Draft guideline

In operation: 15/05/2008–31/08/2016

Published: 10/10/2007

Published: 11/10/2006

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