ORPHAN DRUGS FEATURETTE

BY ALAN OSBORNTHREE years after it was launched by the London-based European Agency for the Evaluation of Medicinal Products (EMEA), the new procedure for the designation of orphan drugs and for assisting in their development is widely judged a success though there remain serious questions over actually getting the authorised drugs to patients.Under the system, administered by the Agency's Committee for Orphan Medicinal Products (COMP), there is a 100 per cent waiver of protocol assistance fees for products designated as orphan drugs and a 50 per cent waiver on ...


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