European Medicines Agency
The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the processes related to the evaluation of applications for marketing authorization of medicinal products in the European Union and monitoring. It began operating in 1995.
Its aim is "to contribute to the protection of public and animal health by ensuring that medicines for human use are safe, effective and high quality."
The EMA is composed of scientists from all member states of the European Union, including more than 40 national competent authorities in this matter, that if our country is the Spanish Medicines Agency (link is external). With regard to orphan drugs, there COMP (European Medicines Agency's Committee for Orphan Medicinal Products) responsible for licensing and evaluation of these drugs.
It is understood by orphan drug, according to WHO (link is external) as that for the prevention, diagnosis or treatment of rare diseases or common serious diseases but that would hardly be marketed by lack of sales prospects once in the market. When a pharmaceutical company obtained marketing authorization for an orphan drug is licensed for a period of 10 years and a number of benefits to the process of evaluation.
More information at:
- Regulation (EC) No 141/2000 of the European Parliament and of the Council of of 16 th December 1999 on orphan medicinal product
- Guideline on the format and content of applications for designation as orphan medicinal
- Inventory of Community and Member States' incentive measures to aid the research, marketing, development of orphan drugs