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Japan Limits Company Contributions To Drug Review Board Members

This article was originally published in PharmAsia News

Executive Summary

Japan's Ministry of Health, Labor and Welfare approved a new rule regulating the voting rights of review board members. The rule states that members of the drug review board who received more than ¥5 million in a single year over the past three years will not be allowed to review and vote on applications, and members who received more than ¥500,000 but less than ¥5 million will not be able to vote.The scope of contributions include: contributions to scholarships, compensation such as patient usage fees and contributions to voting members' immediate relatives.Last year, Chugai Pharmaceutical, the Japanese distributor of Tamiflu (oseltamivir), was found contributing money to members of a research team studying the relationship between abnormal behavior and Tamiflu use. The new regulation is an effort to keep MHLW's drug approval procedure fair and transparent. (Click here for more

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