Committee for Orphan Medicinal Products (COMP)

The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing applications from people or companies seeking 'orphan medicinal product 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.

See the full overview of the COMP's role.

Composition

The members and alternates of the COMP are nominated by the EU Member States, in consultation with the Agency's Management Board. They are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicinal products. They serve on the Committee for a renewable period of three years.

The COMP is composed of:

a chair, elected by serving COMP members;
one member nominated by each of the 27 Member States;
three members nominated by the European Commission to represent patients' organisations;
three members nominated by the European Commission on the Agency's recommendation;
one member nominated by Iceland, one by Liechtenstein and one by Norway;
one European Commission representative;
general observers.