Pacific Bridge Medical - Asian Medical Publications
Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2007
Published by Pacific Bridge Medical	Print Article
By Ames Gross and John Minot	2007

Price: $1500

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 Asia and orphan drug associations are also included.

Fully updated for 2007.

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This report is 96 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

  E. US Orphan Drug Associations

  F. 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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