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
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