EU: GMP-Annex 2 revised - Details defined for biological products including ATMPs

19.04.2010
- Draft out for comments until July 15, 2010 -
 
On April 19, 2010 the European Commission published the revised draft of GMP
Annex 2: Manufacture of Biological Medicinal Substances and Products for Human Use. You can find the document under http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/latest_news/
gmp_annex2_03-2010.pdf

The revised draft of GMP Annex 2 contains additional guidance for the manufacture of biological medicinal products and specific guidance for certain types of products, e.g. ATMPs. This new draft reflects latest legislation and comments received from industry on the previous draft version.


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