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.
pharmind 2009, Nr. 10, Seite 1712