AN ORPHAN DRUG FRAMEWORK (ODF) FOR CANADA

被引：0

作者：

Lee, David K. ^{[1
]}

Wong, Barbara ^{[1
]}

机构：

[1] Off Legislat & Regulatory Modernizat Policy, Planning & Int Affairs, Hlth Prod & Food Branch, Hlth Canada, Ottawa, ON, Canada

来源：

JOURNAL OF POPULATION THERAPEUTICS AND CLINICAL PHARMACOLOGY | 2014年 / 21卷 / 01期

关键词：

Orphan drug; regulation; Canada;

D O I：

暂无

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：E42 / E46

页数：5

共 9 条

[1]

European Commission Health and Consumer Protection Directorate-General, 2008, RAR DIS EUR CHALL DO

[2]

European Medicines Agency, 2012, FEE RED DES ORPH MED

[3]

Health Canada, 2013, SPEC ACC PROGR DAT

[4] Despite surge in orphan drug designations, approvals still lag [J].

Heger, Monica .

NATURE MEDICINE, 2011, 17 (03) :236-236

[5]

OAG, 2011, CLIM CHANG PLANS KYO

[6]

Standing Senate Committee on Social Affairs Science and Technology, 2013, PRESCR PHARM CAN POS

[7]

The Standing Senate Committee on Social Affairs, 2012, CAN CLIN TRIAL INF P

[8]

US Government Printing Office, 2013, 21 CFR 316

[9] European regulation on orphan medicinal products: 10 years of experience and future perspectives [J].

Westermark, Kerstin ;

Holm, Birthe Byskov ;

Soderholm, Mirjam ;

Llinares-Garcia, Jordi ;

Riviere, Frida ;

Aarum, Stiina ;

Butlen-Ducuing, Florence ;

Tsigkos, Stelios ;

Wilk-Kachlicka, Agnieszka ;

N'Diamoi, Cinzia .

NATURE REVIEWS DRUG DISCOVERY, 2011, 10 (05) :341-349

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