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
-
List item
Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer (PDF/47.55 KB)
Adopted
First published: 10/10/2007
Last updated: 10/10/2007
Legal effective date: 15/05/2008
EMEA/CHMP/BWP/271475/2006 -
List item
Overview of comments received on draft guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer (PDF/58.19 KB)
First published: 10/10/2007
Last updated: 10/10/2007
EMEA/CHMP/BWP/329778/2007 -
List item
Draft guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer (PDF/48.98 KB)
Draft: consultation closed
First published: 11/10/2006
Last updated: 11/10/2006
EMEA/CHMP/BWP/271475/2006