EU and US unite on orphan drugs, aim for further harmonisation

Science|Business

The European Commission, the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have agreed a common application form for companies applying for orphan drug designation in the EU and US, to simplify the process of obtaining orphan status in both jurisdictions.

And yesterday, 28 further areas where the industry would like to see simplification in the approval and marketing authorisation process came under discussion at the Transatlantic Administrative Simplification Workshop in Brussels.

The workshop included representatives from EMEA, the FDA, national regulators and authorities and...

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