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.
|Topic||Documents||Reference number||Publication date||Effective date||Remarks|
|Clinical aspects related to tissue engineered products||EMA/CAT/573420/2009||December 2014||December 2014|
|Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products||CAT/CPWP/686637/2011||March 2013||February 2013|
|CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products||CHMP/CAT/BWP/353632/2010||June 2011||June 2011|
|Reflection paper on stem cell-based medicinal products||Overview of comments|
Adopted reflection paper
Draft reflection paper
|CAT/571134/09||February 2011||January 2011|
|Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee||CAT/CPWP/568181/2009||May 2010||April 2010|
|Potency testing of cell based immunotherapy medicinal products for the treatment of cancer||CHMP/BWP/271475/06||December 2007||May 2008|
|Guideline on xenogeneic cell-based medicinal products||CHMP/CPWP/83508/09||December 2009||January 2010|
|Human cell-based medicinal products||CHMP/410869/06||June 2008||September 2008|
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