About 30 million people living in the European Union (EU) suffer from a rare disease. The European Medicines Agency (EMA) plays a central role in facilitating the development and authorisation of medicines for rare diseases, which are termed ‘orphan medicines‘ in the medical world.
Regarding the US, the FDA has authority to grant orphan drug designations to drugs of biological products to prevent, diagnose or treat a rare disease or condition, with an estimated population of around 30 million people suffering from a rare disease in the country.
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