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Pacific Bridge Medical
- Asian Medical Publications
 
Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan DrugProducts Enter the Asian Market 2007
 
Published by Pacific Bridge Medical
Print Article
By Ames Gross
and
John Minot2007Price: $1500Overview:
Following the example of the US FDA's Orphan Drug Act established in 1983, some Asian nations have developed orphandrug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment tothe
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 regulationsthroughout Asia and discusses various business issues related to orphan drugs in Asia. Lists of approved orphan drugs inAsia and orphan drug associations are also included.
Fully updated for 2007.Click here
to view a sample page.This report is 96 pages.
TABLE OF CONTENTS:I. Introduction 
A. Global Outlook on rare diseasesB. Development of Orphan Drug LegislationC. Well-Known Rare DiseasesD. US FDA Contact InformationE. US Orphan Drug AssociationsF. US FDA Orphan Drug Approvals
II. Overview of Asia
A. The Asian EconomyB. The Pharmaceutical Markets in Asia
III. Orphan Drugs in Asia
 A. Do orphan drugs have potential in Asia?B. Why seek orphan drug status?
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IV. Issues to Consider Prior to Orphan Drug Registration
A. IntroductionB. Are treatment options already available in the country?C. Is your drug superior to those already on the market?D. Conclusion
V. Japan
A. IntroductionB. Ministry of Health, Labor and WelfareC. Pharmaceuticals and Medical Devices AgencyD. Orphan Drugs in JapanE. Health Authority Contact InformationF. Orphan Drug AssociationsG. Orphan Drugs Approved in JapanH. Orphan Drugs Designated in Japan
VI. Taiwan 
A. OverviewB. Taiwanese Health AuthoritiesC. Health Insurance SchemeD. Orphan Drugs in TaiwanE. Health Authority Contact InformationF. Orphan Drug Associations
VII. Korea 
A. OverviewB. Drug Registration OverviewC. Orphan Drugs in KoreaD. Health Authority Contact InformationE. Orphan Drug AssociationsF. Orphan Drugs Approved in Korea
VIII. Hong Kong
A. OverviewB. Drug Registration OverviewC. Orphan Drugs in KoreaD. Health Authority Contact InformationE. Orphan Drug Associations
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F. Orphan Drugs Approved in Korea
IX. China
A. OverviewB. Pharmaceutical MarketC. China Health AuthorityD. Drug Registration ProcessE. Drug PricingF. Orphan Drugs in ChinaG. Health Authority Contact Information
X. Singapore
A. OverviewB. Singapore Health AuthorityC. Orphan Drug Definition and LegislationD. Health Authority Contact Information
XI. Southeast Asia Introduction
A. OverviewB. Drug Registration Requirements for Southeast Asia
XII. Philippines
A. OverviewB. Philippines Health AuthorityC. Orphan Drug Registration ProcessD. Health Authority Contact Information
XIII. Malaysia 
A. OverviewB. Malaysia Health AuthorityC. Drug Registration OverviewD. Health Authority Contact Information
XIV. Thailand
A. OverviewB. Drug Registration OverviewC. Orphan Drug SummaryD. Health Authority Contact Information
XV. Vietnam
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