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18 September 2007

EMEA:
Annex 2 of the GMP Guide

Annex 2 of the GMP Guide has been revised as a consequence of the restructuring of the GMP Guide and the introduction of GMP for active substances used as starting materials. Further revision was necessary due to an increase of breadth of biological products. In addition, with the agreement on the new regulation on advanced therapies (formal adoption and publication pending) the Commission is asked to draw up specific GMP guidelines for advanced therapy medicinal products, including gene therapy, somatic cell therapy medicinal products and tissue engineered products as defined in the regulation. Input from organizations with particular experience in advanced therapies is expected though this public consultation. The relevant section of Annex 2 on tissue engineered products will be developed subsequently.
Comments should be sent by 14 March 2008 to entr-gmp@ec.europa.eu and GMP@emea.europa.eu