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décembre 2009

Advanced therapies

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.