Role of COMP
Evaluating orphan designations
COMP is responsible for evaluating applications for orphan designation. This designation is for medicines to be developed for the diagnosis, prevention or treatment ofrare 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 designationallows a sponsor to benefit from incentives from the EU, such as reduced fees and protection from competition once the medicine is placed on the market.
Expert support
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.
COMP was established in 2000, in line withRegulation (EC) No 141/2000. For full details, see the COMP rules of procedure and work plan.
COMP rules of procedure
English (EN) (169.1 KB - PDF)
COMP work plan 2025
English (EN) (259.51 KB - PDF)
Publication of COMP agendas, minutes and meeting reports
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 toIRIS. 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 atCOMPSecretariat@ema.europa.eu.
COMP publication times
- Agendas
Before start of Committee plenary. EMA has been publishing agendas for COMP since its December 2012 meeting.
- Minutes
After Committee plenary where minutes are adopted. EMA has been publishing minutes for COMP since its December 2012 meeting.
- Meeting reports
After Committee plenary. As of August 2022 and until further notice, COMP no longer publishes meeting reports.
COMP consists of scientific experts nominated by EU Member States
Useful information
Committee for Orphan Medicinal Products (COMP) meetings 2025, 2026, 2027 and 2028
English (EN) (149.68 KB - PDF)
Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities
English (EN) (329.63 KB - PDF)
Upcoming COMP meetings
COMP agendas
Agenda of the COMP meeting 4-6 November 2025
English (EN) (525.02 KB - XLSX)
Agenda of the COMP meeting 7-8 October 2025
English (EN) (522.94 KB - XLSX)
Agenda of the COMP meeting 9-11 September 2025
English (EN) (522.35 KB - XLSX)
COMP minutes
Minutes of the COMP meeting 7-8 October 2025
English (EN) (372.33 KB - XLSX)
Minutes of the COMP meeting 9-11 September 2025
English (EN) (372.29 KB - XLSX)
Minutes of the COMP meeting 15-17 July 2025
English (EN) (388.5 KB - XLSX)
COMP meeting reports
COMP meeting report on the review of applications for orphan designation: July 2022
English (EN) (191.28 KB - PDF)
COMP meeting report on the review of applications for orphan designation: June 2022
English (EN) (175.99 KB - PDF)
COMP meeting report on the review of applications for orphan designation: May 2022
English (EN) (184.29 KB - PDF)
Related documents
Policy 15: Policy on publications by EMA staff and EMA scientific committee members on EMA’s work
English (EN) (256.07 KB - PDF)
Policy 29: Representing the Agency at external events or in professional bodies
English (EN) (123.18 KB - PDF)