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EMA looks at the incidence of rare diseases

The European Medicines Agency has published a document listing information sources for pharmaceutical companies on the incidence of rare diseases.

The initiative is designed to decrease the administrative burden for companies applying for orphan drug status for a product and to encourage the development of medicines for diseases that occur too infrequently to provide a normal commercial market. Sponsors applying for orphan drug status for a medicine are asked to provide authoritative references to demonstrate that the condition that the medicine is intended to treat does not affect more than 5 in 10,000 people in the European Union.

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