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
XII. Philippines
- A. Overview
- B. Philippines Health Authority
- C. Orphan Drug Registration Process
- D. Health Authority Contact Information
XIII. Malaysia
- A. Overview
- B. Malaysia Health Authority
- C. Drug Registration Overview
- D. Health Authority Contact Information
XIV. Thailand
- A. Overview
- B. Drug Registration Overview
- C. Orphan Drug Summary
- D. Health Authority Contact Information
XV. Vietnam
- A. Overview
- B. Drug Registration Overview
- C. Health Authority Contact Information
- D. Orphan Drug Associations
XVI. Sales and Marketing of Orphan Drugs
- A. Introduction
- B. Preparing a Sales Forecast
- C. In-country Support
- D. Distribution
XVII. Conclusion
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