Clinical Studies Using in Vivo Diagnostic Radiopharmaceuticals under the Clinical Research Law
The Japanese Ministry of Health, Labour and Welfare (JMHLW) introduced the Clinical Research Law1 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 Japan...
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Veröffentlicht in: | Annals of Nuclear Cardiology 2018, Vol.4(1), pp.88-93 |
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Sprache: | eng |
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Zusammenfassung: | The Japanese Ministry of Health, Labour and Welfare (JMHLW) introduced the Clinical Research Law1 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. 1This review article was written before official release of the English translation of the Clinical Research Law in June 28 2018. Although the law is officially entitled the Clinical Trials Act in English, this review uses the terminology “the Clinical Research Law”. |
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ISSN: | 2189-3926 2424-1741 |
DOI: | 10.17996/anc.18-00083 |