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Japan To Fast-Track Foreign-Approved Orphan Drugs

This article was originally published in PharmAsia News

Executive Summary

Japan's Health Ministry has earmarked extra funds in its budget this year to speed its approval process for foreign-approved drugs, including creation of a fast-track system. The funding request includes subsidies to drug makers and others to share some of the costs of clinical trials for drugs intended for children and for treating cancer. The plans call for approving fast-tracked drugs in six months and adding staff to the Pharmaceuticals and Medical Devices Agency for product reviews. The new, faster procedure is to be available for about 50 drugs on a list yet to be compiled, primarily orphan drugs. (Click here for more - a subscription may be required

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