title: Worldwide collaboration for orphan drug designation.
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, E14 5EU London, UK.
authors.forename: Segundo
authors.initials: S
authors.lastname: Mariz
authors.affiliation: Office of Orphan Products Development, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
authors.forename: James H
authors.initials: JH
authors.lastname: Reese
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, E14 5EU London, UK; and Läkemedelsverket, Dag Hammarskjölds vägen 42, 75103 Uppsala, Sweden.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Westermark
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, E14 5EU London, UK; and European Organisation for Rare Diseases (Eurordis), 96 rue Didot, 75014 Paris, France.
authors.forename: Lesley
authors.initials: L
authors.lastname: Greene
authors.affiliation: Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau (PFSB), Ministry of Health, Labour and Welfare (MHLW), 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo, 100-8916 Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Goto
authors.affiliation: Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau (PFSB), Ministry of Health, Labour and Welfare (MHLW), 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo, 100-8916 Japan.
authors.forename: Tatsuro
authors.initials: T
authors.lastname: Hoshino
authors.affiliation: Office of Orphan Products Development, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
authors.forename: Jordi
authors.initials: J
authors.lastname: Llinares-Garcia
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, E14 5EU London, UK; and Universidade de Lisboa, Faculdade de Farmácia, 1649-003 Lisboa, Portugal.
authors.forename: Bruno
authors.initials: B
authors.lastname: Sepodes
mesh_terms: D003299:Cooperative Behavior; D014943:Global Health; D006801:Humans; D009965:Orphan Drug Production / Q000379:methods*; D035583:Rare Diseases / Q000517:prevention & control*