The Orphan Drug Designation (ODD) is a status assigned by EMA to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.
We have summarized the work process for you to have always at hand.
Have a look at the complete process:
For further information, queries or assistance, contact us at: info@asphalion.com
Search News & Events
Share
Have a look at a recent success story of how Asphalion helped a local company expand its business internationally, helping it create a growth strategy
Asphalion’s Managing Director, Núria Romero, and Lidia Cánovas, Key Accounts Director will be joining the Medicines for Europe annual conference in Malta next week. The
MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners.
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.
Services
Memberships
Quality Management System
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
