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 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.
COMP also advises and assists the European Commission on matters related to orphan medicines, including:
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.
COMP has been producing meeting reports summarising the main outcomes of its meetings since it was established
Starting with April 2025, EMA is publishing COMP agendas and minutes in Excel format. This change follows the transition of all COMP procedures to IRIS. IRIS is a secure online platform for handling product-related scientific and regulatory procedures with EMA. The change is also in the context of the digitalisation of EMA's activities and will help facilitate data analysis. You can share your feedback on your experience with the new agenda and minutes format at COMPSecretariat@ema.europa.eu.
Before start of Committee plenary. EMA has been publishing agendas for COMP since its December 2012 meeting.
After Committee plenary where minutes are adopted. EMA has been publishing minutes for COMP since its December 2012 meeting.
After Committee plenary. As of August 2022 and until further notice, COMP no longer publishes meeting reports.