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What is a clinical trial ?
The adoption of the European regulation on orphan drugs has led to progress in the management of people affected by rare diseases. Objectives of the European Regulation
The European Orphan Medicinal Products Regulation aims to facilitate access to safe and efficacious drugs for people affected by rare diseases. For that reason, it gives incentives to the pharmaceutical industry to develop, produce and bring orphan medicinal products to the market. Incentives to the pharmaceutical industry
-a reduction of registration fees and annual taxes
-scientific assistance for the elaboration of clinical research protocols
-a 10 year market exclusivity in all the European Union The Committee for Orphan Medicinal Products (COMP)
Created in April 2000, the COMP is the institution responsible for evaluating applications submitted in order to designate the drugs which may qualify for incentives under the European Regulation scheme for orphan medicinal products. The COMP’s recommendations, in which three patient association representatives participate, is followed by approval from the European Commission which grants the official designation to the orphan product.
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