Revision of Annex 2 of the EU GMP Guide "Additional Guidelines for the Manufacture of Biological Medicines for Human Use"

Revision of Annex 2 of the EU GMP Guide "Additional Guidelines for the Manufacture of Biological Medicinal Products for Human Use"

For many industrially manufactured biological products, human tissues or cells are the active ingredients. However, Directive 2004/23/EC for human tissues and cells only covers the areas of donation, procurement, and testing. The rapid development and the increasing number of different new types of biological products, such as transgenically produced products or novel therapies, required new legislation and changes to the GMP guidelines to meet the requirements of Article 5 of Directive 1394/2007 or to adapt to Directive 2009/120/EC.

Already in mid-2010, the European Commission published a revised draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" for the second public consultation. After considering the comments from the first public consultation and the second commentary in 2010, the guideline attempts to address the special conditions arising from the biological origin of the products and also to consider the new types of biological products such as advanced therapy medicinal products (ATMP), transgenic products, etc.

On September 6th, the European Commission finally announced on its website that the revised Annex 2 of the GMP guidelines has now been adopted. The deadline for implementation is set for January 31, 2013.

Author: Axel H. Schroeder

For more information, see the international GMP Compliance for Biopharmaceuticals with ATMP Workshop from October 10-12 in Heidelberg, where this topic will be addressed