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Orphan Drugs in Asia
Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2009

Orphan Drugs in Asia Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2009

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 the U.S., Japan and Korea as well as a list of orphan drug associations are also included.

Fully updated for 2011, with complete lists of orphan drugs approved in the US, Japan and Korea. Statistics, drug registration process infomration and health authority contact information are also fully updated for2011.

1.  Introduction
Global Outlook on rare diseases
Development of Orphan Drug Legislation
Well-Known Rare Diseases
US FDA Contact Information
US Orphan Drug Associations
US FDA Orphan Drug Approvals

2. Overview of Asia

3. Orphan Drugs in Asia

4. Issues to Consider Prior to Orphan Drug Registration

5. Japan
Orphan Drug Associations
Orphan Drugs Approved in Japan
Orphan Drugs Designated in Japan

6. Taiwan

7. Korea

8. Hong Kong

9. China
Orphan Drugs in China
Health Authority Contact Information

10. Singapore

11. Southeast Asia Introduction

12. Philippines

13. Malaysia

14. Thailand

15. Vietnam

16. Sales and Marketing of Orphan Drugs

17. Conclusion

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