This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths – the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.
The EMA Committee for Advanced Therapies (CAT) reviews the quality, safety, and efficacy of Advanced-Therapy Medicinal Products (ATMPs).
The EMA Committee for Orphan Medicinal Products (COMP) reviews applications for orphan-medicinal-product designation.