Abstract
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 2009, with complete lists of orphan drugs approved in Japan
and Korea.
This report is 103 pages.
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