Japan has a clinical trials registry, Japan Registry of Clinical Trials (jRCT). It is a World Health Organization (WHO) recognized primary registry. Japan had a network of 3 additional primary registries which included Japan Pharmaceutical Information Center – Clinical Trials Information (JapicCTI), University Hospital Medical Information Network (UMIN-CTR), and Japan Medical Association Center for Clinical Trials – Clinical Trial Registry (JMACCT-CTR). As per the notification published on JMACCT, the clinical trial information registration center has been unified and from September 01, 2020, the information is to be submitted to jRCT. It is mandatory to register the protocol and post results in jRCT, except for bioequivalence studies.

Registries at a Glance
Registry	PHUSE Categorization	Information to be Entered By	Route of Data in Registry	Study Type	Language
jRCT	Mandatory National Database (includes Ethics Requirement)	Sponsor	Clinical Trial Application	Interventional Phase 1 (except bioequivalence studies); Phase 2 to 4 Observational	Japanese English
JMACCT	Mandatory National Database (includes Ethics Requirement)	Competent authority	Clinical Trial Application	Interventional Phase 1 (except bioequivalence studies); Phase 2 to 4 Observational	Japanese English
UMIN-CTR	Mandatory National Database (includes Ethics Requirement)	Sponsor	Through a dedicated registration platform (process independent from clinical trial application)	Interventional Phase 1 (except bioequivalence studies); Phase 2 to 4 Observational	Japanese English
JapicCTI	Mandatory National Database (includes Ethics Requirement)	Sponsor	Through a dedicated registration platform (process independent from clinical trial application)	Interventional Phase 1 (except bioequivalence studies); Phase 2 to 4 Observational	Japanese English

Registry Updates

• March 2023: Japan registry update - On March 02, 2023, the Japan Registry of Clinical Trials (jRCT) published a notice regarding the updated schedule for data migration. The registered data from two registries – the Japan Medical Association Clinical Trial Registry System (JMACCT-CTR) and the Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) – will be migrated to the Clinical Research … Continue reading "March 2023: Japan registry update"
• February 2023: Japan registry update - On February 16,2023, a notice regarding postponement of data migration was published on Japan Registry of Clinical Trials (jRCT). The listed updates are as follows: The initial schedule of the data migration is postponed due to the time required for the data migration associated with the integration of clinical trial and clinical research databases. jRCT will … Continue reading "February 2023: Japan registry update"
• January 2023: Japan Registry Update - On December 27, 2022, a notice announcing the migration of registered data from the registries, Japan Medical Association Clinical Trial Registry System (JMACCT-CTR) and Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) to the Clinical Research Submission and Disclosure System of jRCT was published on Japan Registry of Clinical Trials (jRCT). The listed updates are … Continue reading "January 2023: Japan Registry Update"

References