An up-dated draft version of Annex 2 was published recently.
With this new document the European Commission pays tribute to significant
developments in the field of biologics during the last years:
the introduction of GMP for active substances used as
starting materials (Part II of the EU-GMP Guide)
the increasing range of biological products
the implementation of the new regulations on advanced
therapies including gene therapy, somatic cell therapy medicinal
products, tissue engineered products.
This short list is reason why the document grew from 5 to
On the other hand you may ask the question if this approach to cover the
complete heterogeneous group of biological products in one single document
can be successful.
The new annex 2 has been divided into two main chapters:
Chapter A describes general GMP requirements which have to be applied to all
biological products. In its structure this part of the document is very
similar to the current annex 2. But many of the demands are described in
more detail and new requirements have been added.
Chapter B contains guidance on individual product classes (monoclonal
antibody products, somatic and xenogenic cell therapy prodcuts, vaccines
Surprisingly the text for tissue engineered products is missing - a class of
biologicals with impressing advancements during the last couple of years.
Due to the complexity of the comprehensive project the European Commission
allows a remarkably long period for consultation until March 14, 2008.
The reading of the new annex is strongly recommended to all who are involved
in the development, production or quality control of biological products -
especially to those colleagues who are engaged in advanced therapies.
Please use this opportunity to forward your comments and suggestions to the
European Commissions - ether directly or via those organisations that
represent your interests. You have the unique chance to influence those
requirements that will have a direct impact on you.
You will find the new draft Annex 2 to the EU-GMP Guide at