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Reportlinker Adds Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2011
Date:4/27/2011

NEW YORK, April 27, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2011

http://www.reportlinker.com/p0486821/Orphan-Drugs-in-Asia-Guidelines-and-Regulatory-Requirements-to-Help-Orphan-Drug-Products-Enter-the-Asian-Market-2011.html

Overview:

Following the example of the US 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 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 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 2011 include:

• Recent 2011 government approval list for orphans drugs in the US and Japan

• Recent issues surrounding rare disease treatment in 10 Asian countries

• Latest orphan drug registration policies and regulations in Asia
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