Research and Markets: Orphan Drugs in Asia 2014-2015

Research and Markets has announced the addition of the "Orphan Drugs in Asia 2014" report to their offering.

Following the example of the FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislations, 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, 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.

The 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 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.

Key Topics Covered:

I. Introduction
II. Overview of Asia
III. Orphan Drugs in Asia
IV. Issues to Consider Prior to Orphan Drug Registration
V. Japan
VI. Taiwan
VII. Korea
VIII. Hong Kong
IX. China
X. Singapore
XI. Southeast Asia Introduction
XII. Philippines
XIII. Malaysia
XIV. Thailand
XV. Vietnam
XVI. Sales and Marketing of Orphan Drugs in Asia
XVII. Conclusion