The Orphan Regulation is an official set of rules explaining the procedure for gaining orphan drug designation from the European Medicines Agency (EMA).
The European Commission (EC) has now released a document which addresses five issues that have emerged since the Orphan Regulation was published in 2000.
To read a summary of the document, visit our website: https://raremark.com/editorial/eu-orphan-drug-regulation-5-key-questions-answered--384