title: [The legal regulation of life cycle of orphan pharmaceuticals].
abstract: The legislation of the USA, countries of EU and Japan is analyzed concerning orphan diseases and pharmaceuticals developed for their treatment (orphan pharmaceuticals). The main characteristics and stages of registration of orphan pharmaceuticals in the USA, countries of EU and Japan are considered. Thee peculiarities of orphan pharmaceuticals and pharmaceutical market of orphan pharmaceuticals in the Russian Federation are discussed. The legislative regulation of turnover of orphan pharmaceuticals in the Russian Federation and corresponding obstacles and perspectives are considered.
authors.forename: G N
authors.initials: GN
authors.lastname: Gildeyeva
authors.forename: T V
authors.initials: TV
authors.lastname: Kartavtsova
mesh_terms: D017277:Drug Approval; D005062:European Union; D006801:Humans; D007564:Japan; D007880:Legislation, Drug; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence*; D035583:Rare Diseases / Q000188:drug therapy*; D012426:Russia; D014481:United States