This document summarizes VCLS’s comments on the Draft Regulation and on the Consultation Paper, published by the European Community on 4 May 2005. They concern the scope of the Regulation, the composition of the Committee for Advanced Therapies, the requirements for a Marketing Authorization and the Incentives.
Voisin Consulting’s comments on the proposed European Regulation on advanced therapy products issued by the European Commission
2005 – European Comission