Orphan designation: research and development

The European Medicines Agency provides support, including regulatory guidance and incentives, for the research and development of medicines for rare diseases in the European Union (EU)

United Kingdom's (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK's withdrawal from the EU.

In this section

In other sections

Sponsors of designated orphan medicines should also consider the regulatory information in the sections below:

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