A high level conference is being organised during the Maltese Presidency to discuss the development of medicinal products for rare disease. This conference will bring together the European Organisation for Rare Diseases (EURORDIS), EU Health Ministers, experts from the Committee of Orphan Medicinal Products (COMP) and the members of the Innovative Medicines Initiative (IMI).

The Committee for Orphan Medicinal Products (COMP) 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. The COMP meets at the European Medicines Agency (EMA) in which representatives of all EU member states participate.

The COMP is also responsible for advising the European Commission on the establishment and development of a policy on orphan medicinal products in the EU. The experts will be contributing to drafting up guidelines on matters relating to orphan medicinal products.





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