The Committee for Orphan Medicinal Products (COMP) is the European Medicines Agency's (EMA) committee responsible for recommending orphan designation of medicines for rare diseases.
The COMP was established in 2000, in line with Regulation (EC) No 141/2000.
The COMP is responsible for evaluating applications for orphan designation. This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU. The European Commission decides whether to grant an orphan designation for the medicine based on the COMP's opinion.
An orphan designation allows a pharmaceutical company to benefit from incentives from the EU, such as reduced fees and protection from competition once the medicine is placed on the market.
The COMP also advises and assists the European Commission on matters related to orphan medicines, including:
- developing and establishing an EU-wide policy;
- drawing up detailed guidelines;
- liaising internationally.
For full details, see:
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