Eudralex Volume 3 Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products
Title:
Eudralex Volume 3 Guideline on the risk-based approach according to annex
I, part IV of Directive 2001/83/EC applied to Advanced
therapy medicinal products
Origin/Publisher:
CAT 7 Westferry Circus œ Canary Wharf œ London E14 4HB œ United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu
Document Type:
Guideline
Content:
Since ATMPs are very diverse in nature (i.e. gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs) and tissue engineering products (TEPs)), a flexible approach to address and evaluate potential risks associated with the clinical use of ATMPs is described in the 'Risk-based approach'.