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

This 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.

Keywords: Immunotherapy, potency testing, cell-based products

Current effective version

Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer - Revision 1

AdoptedLegal effective date: 01/09/2016Reference Number: EMA/CHMP/BWP/271475/2006 rev.1

Document history - Revision 1 (current version)

Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer - Revision 1

AdoptedLegal effective date: 01/09/2016Reference Number: EMA/CHMP/BWP/271475/2006 rev.1

Document history - First version

Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer

AdoptedLegal effective date: 15/05/2008Reference Number: EMEA/CHMP/BWP/271475/2006

Overview of comments received on draft guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer

Reference Number: EMEA/CHMP/BWP/329778/2007

Draft guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer

Draft: consultation closedReference Number: EMEA/CHMP/BWP/271475/2006