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Japan To Link Global Drug Trials To Enable 18-Month Approvals

This article was originally published in PharmAsia News

Executive Summary

Japan's Health Ministry plans to take action to speed drug approval by loosening some of its regulations, possibly including creation of a "global clinical trial institution." The agency is considering the action in recognition of the trend of an increasing number of drug makers to conduct trials in several countries at the same time. The ministry seeks to make the Japanese process comparable to those of its counterparts in the U.S. and Europe. The global institution is seen as a way for the government to meet its five-year plan launched last year to cut drug-approval time to about 18 months, compared with the four years the process requires today. (Click here for more - a subscription may be required

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