Orphan Drugs in Asia Report 2009

Overview:

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 2010, 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 for2010.

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This report is 106 pages.

Introduction
1. Global Outlook on rare diseases
2. Development of Orphan Drug Legislation
3. Well-Known Rare Diseases
4. US FDA Contact Information
5. US Orphan Drug Associations
6. US FDA Orphan Drug Approvals
Overview of Asia
1. The Asian Economy
2. The Pharmaceutical Markets in Asia
Orphan Drugs in Asia
1. Do orphan drugs have potential in Asia?
2. Why seek orphan drug status?
Issues to Consider Prior to Orphan Drug Registration
1. Introduction
2. Are treatment options already available in the country?
3. Is your drug superior to those already on the market?
4. Conclusion
Japan
1. Introduction
2. Ministry of Health, Labor and Welfare
3. Pharmaceuticals and Medical Devices Agency
4. Orphan Drugs in Japan
5. Health Authority Contact Information
6. Orphan Drug Associations
7. Orphan Drugs Approved in Japan
8. Orphan Drugs Designated in Japan
Taiwan
1. Overview
2. Taiwanese Health Authorities
3. Health Insurance Scheme
4. Orphan Drugs in Taiwan
5. Health Authority Contact Information
6. Orphan Drug Associations
Korea
1. Overview
2. Drug Registration Overview
3. Orphan Drugs in Korea
4. Health Authority Contact Information
5. Orphan Drug Associations
6. Orphan Drugs Approved in Korea
Hong Kong
1. Overview
2. Drug Registration Overview
3. Orphan Drugs in Korea
4. Health Authority Contact Information
5. Orphan Drug Associations
6. Orphan Drugs Approved in Korea
China
1. Overview
2. Pharmaceutical Market
3. China Health Authority
4. Drug Registration Process
5. Drug Pricing
6. Orphan Drugs in China
7. Health Authority Contact Information
Singapore
1. Overview
2. Singapore Health Authority
3. Orphan Drug Definition and Legislation
4. Health Authority Contact Information
Southeast Asia Introduction
1. Overview
2. Drug Registration Requirements for Southeast Asia
Philippines
1. Overview
2. Philippines Health Authority
3. Orphan Drug Registration Process
4. Health Authority Contact Information
Malaysia
1. Overview
2. Malaysia Health Authority
3. Drug Registration Overview
4. Health Authority Contact Information
Thailand
1. Overview
2. Drug Registration Overview
3. Orphan Drug Summary
4. Health Authority Contact Information
Vietnam
1. Overview
2. Drug Registration Overview
3. Health Authority Contact Information
4. Orphan Drug Associations
Sales and Marketing of Orphan Drugs
1. Introduction
2. Preparing a Sales Forecast
3. In-country Support
4. Distribution
Conclusion

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Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2010

Overview:

TABLE OF CONTENTS: