COMP Recommends Orphan Designation for Nine Substances
The COMP recommendations for these substances are now being sent to the European Commission for the adoption of a decision.
During its December 2011 meeting, the Committee for Orphan Medicinal Products (COMP) recommended granting orphan designation for nine substances.
The COMP recommendations for these substances are now being sent to the European Commission for the adoption of a decision. Once an orphan designation has been granted, sponsors have access to certain incentives during the development of the medicine.
Orphan designation can be granted early in the development process to substances that are intended for diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10 000 people in the European Union or that would not be developed without incentives.
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