EU Biological Product GMPs Will Expand in Breadth and Depth With New Annex 2

The soon-to-be finalized overhaul of EU GMP Annex 2 will significantly expand the breadth and depth of its coverage of the manufacture of biological products and will bring advanced therapy medicinal products (ATMPs) and those transgenically-derived under its umbrella.

The update to the 20-year-old annex will reflect the changes to the EU legislation and GMPs and the advances in science and technology that have fostered a new generation of biologicals.

The revision will harmonize with the more current ICH and FDA guidances on biological products. Included will be requirements for traceability of all materials that come into contact with tissues and cells used in the production of the covered products.

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The Annex 2 revision process began with a concept paper in 2005 and has included two public consultations.  Once the final text is agreed to by the EMA GMP/GDP Inspectors Working Group (IWG), it will be submitted to the European Commission (EC) for adoption.

The rapporteur for the Annex 2 revision, Ian Rees, provided an update on the revision at a session on biotech regulatory CMC sponsored by the European Biopharmaceutical Enterprises (EBE), held in conjunction with the annual CASSS/FDA/EMA CMC Strategy Forum in Barcelona in late March.  Rees is an expert GMP inspector for the UK’s Medicines Healthcare products Regulatory Agency (MHRA) and is a member of the EMA’s GMP/GDP IWG.

He explained that the current Annex 2 with some changes has become Part A in the new revision, and that a new part B has been added to expand the coverage of the various biological product types it covers including ATMPs.  In addition, a glossary is now provided with the annex.

[An analysis of the revision, and the insights provided by rapporteur Ian Rees, are provided for subscribers here.  Nonsubscribers can purchase the full story for $195 by contacting Karen Bertani (  For subscription/license information, click here.]