COMP

Committee for Orphan Medicinal Products

The Committee for Orphan Medicinal Products (COMP) is a scientific committee of the European Medicines Agency (EMA). Its role is to provide scientific and technical advice on all aspects of orphan medicinal products, including applications for orphan drug designation. The COMP is also responsible for maintaining the European Union (EU) Register of orphan medicinal products.

 

The COMP is composed of scientific experts in the field of human medicines, appointed by the Agency’s Management Board. The members of the COMP reflect a broad range of disciplines and geographical regions.

 

The COMP meets approximately every two months. At each meeting, the committee reviews applications for orphan drug designation, as well as applications for changes to existing orphan drug designations. The committee also reviews periodic safety update reports for orphan medicinal products and makes recommendations on whether any action is needed.

 

The meetings of the COMP are open to the public, and the minutes of the meetings are published on the Agency’s website.

 

The COMP has adopted a number of working procedures, which are available on the Agency’s website.

 

Further information on the work of the COMP is available in the annual report of the Committee for Orphan Medicinal Products.


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