EMA: Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of notified bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007

Advanced Therapy Medicinal Products (ATMPs) offer new treatment opportunities for diseases and injuries of the human body. The regulatory framework established by the new legislation on ATMPs is designed to ensure the free movement of these medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical and medical technology companies in the field, while guaranteeing the highest level of health protection for patients.