Following the example of the US FDA' s Orphan Drug Act established in 1983,
some Asian nations have developed orphan drug legislation, such as Singapore' s
Orphan Drug Exemption to the Medicines Act and Japan' s Orphan Drug Amendment
to the Pharmaceutical Affairs Law. While orphan drug laws in Asia may provide
benefits for companies registering new drugs, such as marketing exclusivity,
an expedited registration process, and a reduction in the number of clinical
trials required, each registration process is unique and can pose a variety of
challenges. This report reviews the orphan drug regulations throughout Asia
and discusses various business issues related to orphan drugs in Asia. Lists
of approved orphan drugs in Asia and orphan drug associations are also
included.
Fully updated for 2009, with complete lists of orphan drugs approved in Japan
and Korea.
This report is 103 pages.
Table of Contents
I. Introduction
A. Global Outlook on rare diseases
B. Development of Orphan Drug Legislation
C. Well-Known Rare Diseases
D. US FDA Contact Information
F. US Orphan Drug Associations
G. US FDA Orphan Drug Approvals
II. Overview of Asia
A. The Asian Economy
B. The Pharmaceutical Markets in Asia
III. Orphan Drugs in Asia
A. Do orphan drugs have potential in Asia?
B. Why seek orphan drug status?
IV. Issues to Consider Prior to Orphan Drug Registration
A. Introduction
B. Are treatment options already available in the country?
C. Is your drug superior to those already on the market?
D. Conclusion
V. Japan
A. Introduction
B. Ministry of Health, Labor and Welfare
C. Pharmaceuticals and Medical Devices Agency
D. Orphan Drugs in Japan
E. Health Authority Contact Information
F. Orphan Drug Associations
G. Orphan Drugs Approved in Japan
H. Orphan Drugs Designated in Japan
VI. Taiwan
A. Overview
B. Taiwanese Health Authorities
C. Health Insurance Scheme
D. Orphan Drugs in Taiwan
E. Health Authority Contact Information
F. Orphan Drug Associations
VII. Korea
A. Overview
B. Drug Registration Overview
C. Orphan Drugs in Korea
D. Health Authority Contact Information
E. Orphan Drug Associations
F. Orphan Drugs Approved in Korea
VIII. Hong Kong
A. Overview
B. Drug Registration Overview
C. Orphan Drugs in Korea
D. Health Authority Contact Information
E. Orphan Drug Associations
F. Orphan Drugs Approved in Korea
IX. China
A. Overview
B. Pharmaceutical Market
C. China Health Authority
D. Drug Registration Process
E. Drug Pricing
F. Orphan Drugs in China
G. Health Authority Contact Information
X. Singapore
A. Overview
B. Singapore Health Authority
C. Orphan Drug Definition and Legislation
D. Health Authority Contact Information
XI. Southeast Asia Introduction
A. Overview
B. Drug Registration Requirements for Southeast Asia
