[孤儿药生命周期的法律监管]

[The legal regulation of life cycle of orphan pharmaceuticals].

作者信息

Gildeyeva G N, Kartavtsova T V

出版信息

Probl Sotsialnoi Gig Zdravookhranenniiai Istor Med. 2014 May-Jun(3):37-42.

PMID:25219041

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.

摘要

对美国、欧盟国家和日本关于罕见病及用于治疗罕见病的药品（孤儿药）的立法进行了分析。探讨了美国、欧盟国家和日本孤儿药注册的主要特点和阶段。讨论了俄罗斯联邦孤儿药及孤儿药药品市场的特点。分析了俄罗斯联邦孤儿药流通的立法监管以及相应的障碍和前景。