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The Japanese Ministry of Health, Labour andWelfare (JMHLW) introduced the Clinical Research Law 1 in April 2018. Clinical studies to evaluate pharmacokinetics or the efficacy or safety of in vivo diagnostic radiopharmaceuticals have to be conducted under either the Clinical Research Law or the Japanese Good Clinical Practice (GCP) guidelines. The Clinical Research Law provides stricter regulation than does the current Ethical Guideline for clinical studies, and it allows the regulatory authority to issue orders to suspend or change clinical studies. Given that a clinical study may require the same amount of time, human resources and funding resources no matter which regulatory scheme is followed, clinical investigators need to bear in mind the objectives and funding support for the planned study when choosing which legislation to adhere to. This article reviews various factors that may help determine which of the recently introduced pieces of legislation is applicable in the planning of a particular clinical study. We also aim to establish approaches to identify the appropriate law and to enable non-clinical studies to move forward to the clinical study phase.

Clinical Studies Using <I>in Vivo</I> Diagnostic Radiopharmaceuticals under the Clinical Research Law