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