Regulatory landscape for cell therapy – EU view

Author:

McBlane James W.

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference13 articles.

1. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

2. Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23 of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.

3. Directive 2006/86/EC of 24 October 006 of 8 February 2006 implementing Directive 2004/23 of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.

4. Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma.

5. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, procurement, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.

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