With the intention to promote global clinical trials in which Japan is involved, the ideas and points to consider in conducting global clinical trials are shown in “Basic Principles on Global Clinical Trials” (Notification dated September 28, 2007, issued by the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare) and “Basic Principles on Global Clinical Trials (Reference Cases)” (Administrative Notice dated September 5, 2012, issued by the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; hereinafter referred to as the “Administrative Notice”).
The attachment to the Administrative Notice (“Basic Principles on Global Clinical Trials [Reference Cases]”) has been amended to reflect updated guidance on the evaluation of the long-term safety of a drug in Japanese subjects conducted after confirmatory global clinical trials of the drug. The pre- and post-amendment versions of Reference No. 17 are shown below. We ask you to inform related parties falling under your jurisdiction about the updated guidance.
The revised document of “Basic Principles on Global Clinical Trials (Reference Cases)” is presented in the attachment.
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