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  • Orphan Drugs in Asia 2008

    Transféré par

    Karrie Wang
    531 vues4 pages
    This report reviews the orphan drug regulations in countries throughout Asia and discusses various business issues associated with the registration of an orphan drug. The research, development, and marketing of drugs for rare diseases is not always financially beneficial for pharmaceutical companies, so they are generally reluctant to develop and market them under "standard" conditions and requirements. As a result, some countries have implemented regulations specifically for pharmaceuticals used to treat rare diseases, termed "orphan drugs." Several Asian nations have developed orphan drug legislation. Orphan drug laws in Asia may benefit companies; however, each country has specific registration requirements that can pose significant challenges. This report will address these country-specific regulations and provide a list of approved orphan drugs and orphan drug associations in Asian countries.

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    This report reviews the orphan drug regulations in countries throughout Asia and discusses various business issues associated with the registration of an orphan drug. The research, development, and marketing of drugs for rare diseases is not always financially beneficial for pharmaceutical companies, so they are generally reluctant to develop and market them under "standard" conditions and requirements. As a result, some countries have implemented regulations specifically for pharmaceuticals used to treat rare diseases, termed "orphan drugs." Several Asian nations have developed orphan drug legislation. Orphan drug laws in Asia may benefit companies; however, each country has specific registration requirements that can pose significant challenges. This report will address these country-specific regulations and provide a list of approved orphan drugs and orphan drug associations in Asian countries.

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    Attribution Non-Commercial (BY-NC)
    Téléchargez comme PDF ou lisez en ligne sur Scribd
    Signaler comme contenu inapproprié
    531 vues4 pages

    Orphan Drugs in Asia 2008

    Transféré par

    Karrie Wang
    This report reviews the orphan drug regulations in countries throughout Asia and discusses various business issues associated with the registration of an orphan drug. The research, development, and marketing of drugs for rare diseases is not always financially beneficial for pharmaceutical companies, so they are generally reluctant to develop and market them under "standard" conditions and requirements. As a result, some countries have implemented regulations specifically for pharmaceuticals used to treat rare diseases, termed "orphan drugs." Several Asian nations have developed orphan drug legislation. Orphan drug laws in Asia may benefit companies; however, each country has specific registration requirements that can pose significant challenges. This report will address these country-specific regulations and provide a list of approved orphan drugs and orphan drug associations in Asian countries.

    Droits d'auteur :

    Attribution Non-Commercial (BY-NC)
    Téléchargez comme PDF ou lisez en ligne sur Scribd
    Signaler comme contenu inapproprié
    sur 4

    1/15/2009 Asia Medical Consulting, Regulatory A…

    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.

    Click here to view a sample page.

    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?

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    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


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    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

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    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

    Order now and we will ship you your report at NO ADDITIONAL CHARGE.

    Price: $1500

    Contact us at researchstore@pacificbridgemedical.com if you have questions.

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