EMEA and EU Commission – Topical News
Draft of a Commission Regulation implementing the Regulation on Advanced Therapies with regard to the evaluation and certification of quality and non-clinical data developed by micro, small and medium-sized enterprises
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 submitted a proposal for a Commission Regulation governing the evaluation and certification of quality and non-clinical data on advanced therapy medicinal products developed by micro, small and medium-sized companies as well as a draft Directive amending the Annex to Directive 2001/83/EC in relation to the requirements set up for marketing authorisation applications for advanced therapy medicinal products. The draft 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. 5, Seite 803