Following the FDA’s successful implementation of the Orphan Drug Designation (ODD) program in the US in 1983, the European Medicines Agency (EMA) introduced its own version in 2000 to support the development of treatments for rare diseases across the EU. When awarded, the orphan designation provides a sponsor additional support and financial benefits to incentivize the advancement of treatments in the rare disease space that is not generally available to all sponsors.
In this whitepaper, our experts explain EMA ODDs, discuss the incentives of pursuing this designation, and provide insight into the application process.
Written By:
Clara Bechtold, PharmD Candidate
Edited By:
Paula Garcia Calavia, PhD, Director, Regulatory Affairs
Edited By:
Isaiah Manoogian, PharmD, Senior Regulatory Affairs Scientist
