The European Medicines Agency (EMA) supports Rare Disease Day 2015 taking place on Saturday 28 February.

A rare disease affects not more than 5 in 10,000 people; however, altogether about 30 million people suffer from these diseases in the European Union (EU).

The Agency plays an important role in the development and authorisation of medicines for rare diseases, known as orphan medicines. EMA’s Committee for Orphan Medicinal Products (COMP) issues recommendations to grant orphan designation to medicines, and marketing-authorisation applications for designated orphan medicines are assessed by EMA rather than in each Member State separately.

Companies that have been granted an orphan designation for their medicine benefit from a number of incentives, including reduced fees for marketing-authorisation applications, scientific advice (protocol assistance) and paediatric investigation plans, as well as protection from market competition once the medicine is authorised through a 10-year market-exclusivity period. These incentives aim to bring more medicines for rare diseases to patients.

Since the entry into force of the EU orphan regulation in 2000, more than 100 medicines for rare disease have been brought to the EU market.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/02/news_detail_002277.jsp&mid=WC0b01ac058004d5c1