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

Titel:
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
Internet:

https://www.gmp-navigator.com/files/guidemgr/guideline-risk-based-approach-according-annex-i-part-iv-directive-200183ec-applied-advanced-therapy-medicinal-products_en.pdf

Herkunft/Verlag:

CAT 7 Westferry Circus, Canary Wharf, London E14 4HB, 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

Dokumentenart:
Guideline
Inhalt:
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'.

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