Multidisciplinary: Cell therapy and tissue engineering

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This page lists the scientific guidance documents on cell therapy and tissue engineering.

If you have comments on a document which is open for consultation, please use the form for submission of comments on scientific guidelines.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Clinical aspects related to tissue engineered products

Overview of comments

Adopted reflection paper

Draft reflection paper

EMA/CAT/573420/2009December 2014December 2014  
Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products

Adopted guideline

Draft guideline

Concept paper

CAT/CPWP/686637/2011March 2013February 2013 
CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products

Adopted guideline

Overview of comments

Draft guideline

CHMP/CAT/BWP/353632/2010June 2011June 2011 
Reflection paper on stem cell-based medicinal productsOverview of comments
Adopted reflection paper
Draft reflection paper
CAT/571134/09February 2011January 2011 
Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee

Overview of comments

Draft reflection paper

Adopted reflection paper

CAT/CPWP/568181/2009May 2010April 2010 
Potency testing of cell based immunotherapy medicinal products for the treatment of cancer

Overview of comments

Adopted guideline

Draft guideline

CHMP/BWP/271475/06December 2007May 2008 
Guideline on xenogeneic cell-based medicinal products

Adopted guideline

Draft guideline

Concept paper

CHMP/CPWP/83508/09December 2009January 2010 
Human cell-based medicinal products

Overview of comments

Adopted guideline

Draft guideline

CHMP/410869/06June 2008September 2008 

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