ATMP Regulation roadmap

Click below in the overview map to navigate to all available documents in that area.

ATMP-base

Procurement

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General	Weblink
Directive 2004/23/EC	EUR-Lex – 02004L0023-20090807 – EN – EUR-Lex
Directive 2002/98/EC	EUR-Lex – 02002L0098-20090807 – EN – EUR-Lex
EMA/CAT/600280/2010 1995 rev.1	Reflection paper on classification of advanced therapy medicinal products
EMEA/410/01 rev.3	Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3)

GTMP/

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GTMP	Title of document	Current version	Link
CHMP/BWP/2458/03	GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF LENTIVIRAL VECTORS	26/May/05	Development and manufacture of lentiviral vectors – Scientific guideline \| European Medicines Agency (EMA)

SCTMP or TEP

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SCTMP/TEP	Title of document	Current (consolidated) version	Weblink
EMEA/CHMP/410869/2006	GUIDELINE ON HUMAN CELL-BASED MEDICINAL PRODUCTS	21/May/08	Human cell-based medicinal products – Scientific guideline \| European Medicines Agency (EMA)
EMEA/CHMP/CPWP/83508/2009	GUIDELINE ON XENOGENEIC CELL-BASED MEDICINAL PRODUCTS	01/Dec/09	Xenogeneic cell-based medicinal products – Scientific guideline \| European Medicines Agency (EMA)
EMA/CHMP/BWP/706271/2010	Guideline on plasma-derived medicinal products	29/Jul/11	Plasma-derived medicinal products – Scientific guideline \| European Medicines Agency (EMA)
01/2008:20729	Ph. Eur. 2.7.29. NUCLEATED CELL COUNT AND VIABILITY	needs updating	Linking not possible (subscription required)
01/2008:50203	Ph. Eur. General Text 5.2.3: Cell substrates for the production of vaccines for human use	needs updating	Linking not possible (subscription required)

CPWP/BWP/269/95, rev.3	Note for guidance on plasma derived medicinal products (CPMP/BWP/269/95)	25/Jan/01	Note for Guidance on Plasma-Derived Medicinal Products
CPMP/BWP/3354/99	Guideline on production and quality control of animal immunoglobulins and immunosera for human use	21/Jul/16	Production and quality control of animal immunoglobins and immunosera for human use – Scientific guideline \| European Medicines Agency (EMA)