Home » EMEA Seeks Input on Requirements for Orphan Medicine Designation
EMEA Seeks Input on Requirements for Orphan Medicine Designation
The European Medicines Agency’s (EMEA) Committee for Orphan Medicinal Products (COMP) has released a draft discussion paper outlining the level of evidence required to support an orphan medicines designation. The paper draws on experience with several hundred orphan drug designation applications, more than two-thirds of which discussed significant benefits of the treatments, the COMP says. Comments on the draft are due July 21.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor
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