Abstract

Marketing Authorisation Procedure for ATMPs

Matthias Wilken, Head of Drug Regulatory Affairs Europe / Scientific Aspects in Social Law, German Pharmaceutical Industry Association

On 30 December 2008, legislation on advanced-therapy medicines came into force in the European Union. The legislation defines what products are 'advanced-therapy medicinal products' (ATMP) and describes how they are authorised, supervised and monitored to ensure that they are safe and effective. All advanced-therapy medicines are authorised centrally via the European Medicines Agency. The Agency's Committee for Advanced Therapies (CAT) plays a central role in the scientific assessment of ATMPs. It provides the expertise that is needed to evaluate advanced-therapy medicines. Based on the CAT opinion, the Committee on Human Medicinal Products adopts a recommendation for the European Commission to grant or refuse a marketing authorisation. The CAT provides a certification procedure for ATMPs under development by micro, small and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development. Companies can apply to the European Medicines Agency to determine whether a medicine they are developing is an ATMP. Under Article 3 (7) of 2001/83/EC, there is an exemption from central marketing authorisation for ATMPs that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under certain further conditions. Member States are required to put in place arrangements at national level to meet the specific requirements set out in the Regulation.