Orphan Drugs in Asia Report 2017

Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market

Following the example of the U.S. FDA’s Orphan Drug Act established in 1983, some Asian countries 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 laws on orphan drugs in Asia may provide benefits for companies registering new drugs, including 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 updated report reviews the orphan drug regulations in 10 Asian countries and discusses various business issues related to orphan drugs in the region. Lists of approved orphan drugs in Japan and Korea as well as a list of orphan drug associations are also included.

Updates for 2017 include:

• Expansion of the orphan drug definition in Japan
• Proposed new orphan drug policies by the China Food and Drug Administration (CFDA)
• 2016 Rare Disease Act in the Philippines
• Case studies on orphan drug pricing and funding in Southeast Asia and China

To download this report, please click on Orphan Drugs in Asia Report 2017

Updates for 2014 include:

• Recent 2014 government approval list for orphan drugs in Taiwan
• Updated application forms and requirements in Japan, Taiwan, Korea, Hong Kong and China
• Latest registration policies and regulations on orphan drugs in Asia
• New information involving priority review and regulations in Asia
• Recent data involving orphan drugs market in Asian countries
• 2014 updated fees for Orphan Drug application processes for Japan, China, Korea, and Hong Kong
• Updated contact information for government health agencies in each Asian country

To download the previous version of this report, please click on Orphan Drugs in Asia Report 2014

Table of Contents:

1. 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
2. Overview of Asia
   1. The Asian Economy
   2. The Pharmaceutical Markets in Asia
3. Orphan Drugs in Asia
   1. Do orphan drugs have potential in Asia?
   2. Why seek orphan drug status?
4. 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
5. 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
6. 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
7. 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
8. Hong Kong
   1. Overview
   2. Hong Kong Health Authority
   3. Orphan Drugs In Hong Kong
   4. Health Authority Contact Information
9. 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
10. Singapore
    1. Overview
    2. Singapore Health Authority
    3. Orphan Drug Definition and Legislation
    4. Health Authority Contact Information
11. Southeast Asia Introduction
    1. Overview
    2. Drug Registration Requirements for Southeast Asia
12. Philippines
    1. Overview
    2. Philippines Health Authority
    3. Orphan Drug Registration Process
    4. Health Authority Contact Information
13. Malaysia
    1. Overview
    2. Malaysia Health Authority
    3. Drug Registration Overview
    4. Health Authority Contact Information
    5. Orphan Drug Associations
14. Thailand
    1. Overview
    2. Drug Registration Overview
    3. Orphan Drug Summary
    4. Health Authority Contact Information
15. Vietnam
    1. Overview
    2. Drug Registration Overview
    3. Health Authority Contact Information
    4. Orphan Drug Associations
16. Sales and Marketing of Orphan Drugs in Asia
    1. Introduction
    2. Preparing a Sales Forecast
    3. In-country Support
    4. Distribution
17. Conclusion