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Medicines for rare diseases

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Published on May 16, 2012

The European Medicines Agency plays a central role in the development and authorisation of medicines for rare diseases. These medicines are termed 'orphan medicines' in the medical world.

Rare diseases are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in European Union (EU). Since the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing medicines intended for small numbers of patients, the EU offers a range of incentives to encourage the development of these medicines.

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