Japan

DCT Feasibility Assessment Japan The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current and proposed regulatory landscape applicable in Japan in relation to Decentralized Clinical Trials (“DCT”). Clinical Trials are governed in Japan by the Pharmaceutical and Medical Device Agency...

2.1 Name of Regulatory Authority Japan’s Ministry of Health, Labor and Welfare (MHLW) is the regulatory body that oversees food and drugs in Japan. The Pharmaceuticals and Medical Device Agency (PMDA) is an independent agency that i...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   As outlined in the " Ministerial Ordinance on Good Clinical Practice for Drugs (2012) ",...

Clinical Trial Applications (CTAs) are reviewed by the PMDA . 4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The documents required ...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   No , but the PI should be a suitably qualified and experienced professional. 5.2 Does local regulation require any specific...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to  Section 2.7  of this guidebook. 6.2 Does local regulation require any separate consent for biological sp...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . In principle, there is nothing to prevent the implementation of a DCT model...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The Act on the Protection of Personal Information (APPI) regulates privacy protection issues in Japan.  Al...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? The methods of advertisement are subject to review and approval by the IRB....

10.1 Clinical Trial with Investigational Medicinal Product Please refer to Section 4.5 . 10.2 Pediatric Investigation Plan There is no PIP required in Japan. 10.3 Clinical Study (Interventional or Observational) A Clinical Tria...

Ministry of Health, Labour and Welfare of Japan (MHLW)(n.d.) Home Page , MHLW. Pharmaceuticals and Medical Devices Agency (PMDA)(n.d.) Home Page ,  PMDA. Hourei (4 December 2019) Clinical Research Method , Hourei (Japanese Ethics C...

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