--- title: "Whitepaper: EMA Orphan Drug Designation" description: Learn how to leverage an EMA Orphan Drug Designation (ODD) to expedite your drug product development and regulatory review process from our whitepaper. --- [![pace logo header white](https://info.pacelabs.com/hs-fs/hubfs/pace%20logo%20header%20white.png?width=600&height=410&name=pace%20logo%20header%20white.png) ![pace logo header](https://info.pacelabs.com/hs-fs/hubfs/pace%20logo%20header.png?width=600&height=410&name=pace%20logo%20header.png)](https://www.pacelabs.com) - [Analytical + Environmental](https://www.pacelabs.com/analytical-environmental/) - [Life Sciences](https://www.pacelabs.com/life-sciences/) - [Professional Services](https://www.pacelabs.com/professional-services/) - [Blog](https://blog.pacelabs.com/keeping-pace-with-analytical-services) # EMA Orphan Drug Designation      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.     [![FDA Regulatory Consulting](https://no-cache.hubspot.com/cta/default/6835044/4f1f3f73-4bc7-4665-83f7-8cba410e4ca3.png)](https://cta-redirect.hubspot.com/cta/redirect/6835044/4f1f3f73-4bc7-4665-83f7-8cba410e4ca3)   ---   #### AUTHORS   ![Clara Bechtold](https://info.pacelabs.com/hs-fs/hubfs/PLS/SMEs/Clara%20Bechtold.jpg?width=150&height=150&name=Clara%20Bechtold.jpg) **Written By:** **Clara Bechtold**, PharmD Candidate    ![Paula Garcia Calavia, PhD](https://info.pacelabs.com/hs-fs/hubfs/PLS/SMEs/Paula%20Garcia%20Calavia%2c%20PhD.png?width=150&height=150&name=Paula%20Garcia%20Calavia%2c%20PhD.png) **Edited By:** **Paula Garcia Calavia, PhD,** Director, Regulatory Affairs    ![Isaiah Manoogian, PharmD](https://info.pacelabs.com/hs-fs/hubfs/PLS/SMEs/Isaiah%20Manoogian%2c%20PharmD.png?width=150&height=150&name=Isaiah%20Manoogian%2c%20PharmD.png) **Edited By:** **Isaiah Manoogian**, PharmD, Senior Regulatory Affairs Scientist      [![Contact Us](https://no-cache.hubspot.com/cta/default/6835044/98262d2c-8ae1-4867-8da6-84f2b98af8d5.png)](https://cta-redirect.hubspot.com/cta/redirect/6835044/98262d2c-8ae1-4867-8da6-84f2b98af8d5) ### **Get The Whitepaper** ##### ANALYTICAL + ENVIRONMENTAL ANALYTICAL + ENVIRONMENTAL - [Analytical + Environmental](https://www.pacelabs.com/analytical-environmental/) - [Emergency Services](https://www.pacelabs.com/analytical-environmental/emergency-disaster/) - [Statement of Qualifications](https://info.pacelabs.com/hubfs/Statement%20of%20Qualifications/Pace%20SOQ.pdf) ##### LIFE SCIENCES LIFE SCIENCES - [Life Sciences Page](https://www.pacelabs.com/life-sciences.html) - [CDMO/CRO Services](https://www.pacelabs.com/life-sciences/cdmo-cro-services/) - [Central Laboratory Services](https://www.pacelabs.com/life-sciences/central-laboratory-services/) - [Medical Device](https://www.pacelabs.com/life-sciences/medical-device/) ##### PROFESSOINAL SERVICES PROFESSOINAL SERVICES - [Professional Services](https://www.pacelabs.com/professional-services/) - [Regulatory & Compliance](https://www.pacelabs.com/professional-services/regulatory-and-compliance/) - [Scientific Staff](https://www.pacelabs.com/professional-services/scientific-staff/) - [Instrument Services](https://www.pacelabs.com/professional-services/instruments/) - [Facility Qualification](https://www.pacelabs.com/professional-services/facilities/) ##### OTHER OTHER - [Company](https://www.pacelabs.com/company/) - [Careers](https://www.pacelabs.com/careers/) - [Contact](https://www.pacelabs.com/contact-us/) - [Privacy Policy](https://www.pacelabs.com/legal-notice.html) Copyright © 2026 Pace®