Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products - Scientific guideline
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This document provides guidance on the application of the risk-based approach in the preparation of a marketing authorisation application. The concept of a 'Risk-based approach' has been introduced to the legislation with the revision of Annex 1, part IV of Directive 2001/83/EC as amended by Directive 2009/120 EC.
Keywords: Advanced therapy medicinal products (ATMPs), risk-based approach, risk, risk factor
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Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products (PDF/197.79 KB)
Adopted
First published: 08/03/2013
Last updated: 08/03/2013
Legal effective date: 12/02/2013
EMA/CAT/CPWP/686637/2011 -
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Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products (PDF/281.13 KB)
Draft: consultation closed
First published: 24/01/2012
Last updated: 24/01/2012
Consultation dates: 19/01/2012 to 30/06/2012
EMA/CAT/CPWP/686637/2011 -
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Concept paper on the development of a guideline on the risk-based approach according to annex I, part IV of directive 2001/83/EC applied to advanced therapy medicinal products (PDF/41.05 KB)
Draft: consultation closed
First published: 26/01/2010
Last updated: 26/01/2010
Consultation dates: 17/12/2009 to 31/03/2010
EMA/CHMP/CPWP/708420/2009