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U.S. Department of Health and Human Services

For Industry

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Common EMEA/FDA Application for Orphan Medicinal Product Designation

 

The Sponsor of a medicinal product for human use may desire to seek orphan designation of its medicinal product for use to diagnose, treat, or prevent a rare disease or condition from the European Commission in accordance with Regulation (EC) No 141/2000 of 16 December 1999 and Commission Regulation (EC) No 847/2000, and from the United States Food and Drug Administration (FDA) in  accordance with section 526 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360bb).  In such case, the sponsor may apply for orphan designation of the same medicinal product for the same use in both jurisdictions by using this common application for its submissions to the European Medicines Agency (EMEA) and FDA.

 

Please use the following link to access the Common EMEA/FDA Application for Orphan Medicinal Product Designation form/template. 

Note that as of August 12, 2013 there have been some changes in 21 CFR 316.20(b) Content and format of a request for orphan-drug designation.  The Common EMEA/FDA Application for Orphan Medicinal Product Designation form/template has not yet been revised to reflect this change.  Please see 21 CFR 316.20(b) for these changes. 

The most substantive change is that FDA no longer requires a statement of party of interest for an orphan drug designation (page 9 of 10).  Until this change is made, sponsors can leave the Statement of Party of Interest section blank.