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EMEA and EU Commission – Topical News

Advanced Therapy Medicinal Products – Further steps for Implementation of the Advanced Therapy Regulation

RAin Dr. Brigitte Friese

Rechtsanwältin, Wyk-Wrixum auf Föhr (Germany)

The Advanced Therapy Regulation (EC) No. 1394/2007 requires further provisions for its implementation. Therefore, in accordance with the mandate contained in Art. 18 (2) of the Advanced Therapy Regulation the Commission issued Commission Regulation (EC) No. 668/2009 governing the evaluation and certification of quality and nonclinical data on advanced therapy medicinal products developed by micro, small and medium-sized companies. The Commission Regulation provides for the procedure of the evaluation performed by the CAT at the EMEA as well as the minimum requirements regarding the documentation to be submitted for certification.
Furthermore, the Commission issued a Directive (EC) No. 2009/120/EC amending Part IV of the Annex to Directive 2001/83/EC in relation to the special requirements set up for marketing authorisation applications for advanced therapy medicinal products. The Regulation also contains the definitions “gene therapy medicinal product” as well as “somatic cell medicinal product”, in execution of the reference to Part IV of the Annex to the Human Code contained in Art. 2 (1) of the Advanced Therapy Regulation.