Advanced therapies include gene therapy, somatic cell therapy, and tissue engineering. The European Commission proposed regulation of these innovative therapies. Regulation is beneficial for rare disease patients.
Eurordis responded to a public consultation on the Regulation, expressing support for most of the proposed provisions. Eurordis’ reservations included concerns about the proposed Risk Management System, and a fear that the system may generate too many additional regulatory constraints. The regulation was adopted by the European Parliament on 25 April 2007.