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:
The COMP was established in 2000, in line with Regulation (EC) No 141/2000. For full details, see the COMP rules of procedure and work plan.
EMA's Committee for Orphan Medicinal Products (COMP) meets once a month. EMA publishes the agendas, minutes and meeting reports of its plenary meetings. The Committee has been producing meeting reports summarising the main outcomes of its meetings since it was established
Before start of Committee plenary. EMA has been publishing agendas for the COMP since its December 2012 meeting.
After Committee plenary where minutes are adopted. EMA has been publishing minutes for the COMP since its December 2012 meeting.
After Committee plenary. As of August 2022 and until further notice, COMP no longer publishes meeting reports.