For many biological products manufactured by the pharmaceutical industry, human tissue or cells are "active substances". The Directive 2004/23/EC on Human Tissue and Cells covers only the donation, procurement and testing of the tissues and cells. The fast development in the field of biological products, the increase of various types of biologics such as transgenic derived products as well as ATMP required a new legislation and changes in the GMP Guidance to meet the requirements of Article 5 of Regulation 1394/2007 and to align with details in Directive 2009/120/EC.
In the middle of 2012, the European Commission has already published a draft of the revised Annex 2 of the GMP Giudeline for a second consultation. First changes have been made as a result of the first consultation 2008, but some additional information - especially for modern biological products like ATMP or transgene products - were required.
At last, on 6 September, the European Commission announced on their homepage the publication of the long time expected revision of Annex 2. The Guideline takes into account the certain specific considerations arising from the biological nature of the products and the characteristic of the processes. The way biological medicinal products are manufactured, controlled and administered require some particular precautions.
These new developments will be discussed in ECAs Education course "GMP Compliance of Biopharmaceuticals and the additional Workshop on ATMP from 10-12 October 2012 in Heidelberg, Germany.
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)