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Japan Regulator Begins Five-Year Program Of Drug-Approval Reforms

This article was originally published in PharmAsia News

Executive Summary

Japan's Pharmaceuticals and Medical Devices Agency has kicked off a five-year program aimed at reducing the time it takes to get a drug to market. The plan also is intended to step up the country's participation in worldwide clinical trials, an increasing trend in the pharmaceutical industry. PMDA also has a pilot program consisting of a scientific consultation for companies to use before they submit applications for approval of new drugs. The pre-review consultation is designed to occur during Phase III trials. (Click here for more

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