The Orphan Regulation is an official set of rules explaining the procedure for gaining orphan drug designation from the European Medicines Agency (EMA)

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

https://raremark.com/