The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
Japan Officially Drops Japanese PI Requirement before Global Trial Entry
Japan’s health ministry on December 25 clarified its position that additional PI studies in Japanese subjects prior to the country’s participation in multiregional clinical trials (MRCTs) are “not needed” as a general rule. The Ministry of Health, Labor and Welfare…
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