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Japan to use data from outside clinical trials in drug approvals

Bid to speed up review process aimed at getting new medicines to market faster

Japan's health ministry will offer pharmaceutical companies more ways to show that their drugs are effective.

TOKYO -- Japan's health ministry will issue new guidelines next fiscal year aimed at helping new drugs get to market faster, by allowing pharmaceutical companies to use data from outside of clinical trials.

The health ministry will accept medical information for patients that have taken the drug in other settings, in place of, or as a supplement to, data on a placebo group. Requirements for clinical trials, including duration and number of participants, will also be relaxed. The guidelines will be drawn up before this fiscal year ends in March.

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