June 2021: Japan Registry Update

Updated Field of jRCT

A pre-registration content check sheet was posted on June 29, 2021 on Japan Registry of Clinical Trials (jRCT).

For registration items of “Other Clinical Studies” and “Clinical Trials”, an input check at the time of registration is added. If the items in the check sheet are not met, the registration can be remanded.

Please click here to go to the original update.

February 2021: Japan Regulatory Update

Japan Clinical Trial Registration System Unification to jRCT

Official notification was published on Center for Clinical Trials, Japan Medical Association (JMACCT) regarding unification of Japanese clinical trial registries into jRCT, in February 2021.

As per the new notification i.e.  August 31, 2nd year of Reiwa (i.e. 2020), Pharmaceuticals and Herbal Medicines 0831 No. 9, the following changes will be applicable to clinical trials after September 01, 2020:

  • The registration of all clinical trials is unified to one center – jRCT (Japan registry  of Clinical Trials)
  • The clinical trials involving  Phase 1 (except bioequivalence studies), phase 2-4 would be registered
  • The language for disclosures information would be made mandatory in English and Japanese
  • The information on the physicians and the medical institutions would be added to enable better accessibility to the public, these details are to be registered in a timely manner

Please click here to go to the original update.

February 2021: Japan Regulatory Update

Updated Fields of jRCT

Below updates were made to the jRCT system for “Specific clinical research”, “Other clinical research (non-specific clinical research only)”, and “Regenerative medicine research” on February 01, 2021:

  • Added the following 4 items in the initial application, change application, and minor change application (regeneration only): about ‘Plan to share IPD’, ‘Plan to share IPD’, ‘Explanation of plan’, and ‘Plan description’
  • Removed the selection of ‘Undecided’ from “Plan to share IPD data” in the end notification, and only “Yes” or “No” needs to be selected
  • Removed the selection of ‘Undecided’ from “Plan to do” and made only “Yes” and “No” for ‘IPD data sharing’ of Plan to share IPD data of ‘Other clinical research’ and ‘Clinical trial’ in initial application, change application, minor change application (other than clinical trial), completion notification.

Please click here to go to the original update.

December 2020: Updated Fields of jRCT

Updated Fields of jRCT

Below updates were made to the jRCT system for “Regenerative Medicine Research” on December 25, 2020:

  • The number of files that can be uploaded for the attached documents (‘others’ which includes explanatory documents that cannot be included in the text) had been increased
  • The English name column was added for the Name of the administrator (representative administrator when conducting as a multicentre joint research) in the applicant information
  • The reception date/notification date is now displayed on the registrant screen.

August 2020: Updated Fields of jRCT

Below updates were made to the jRCT system on August 31, 2020:

  • Entry column was added for the ‘Primary Sponsor’ field
  • The input fields of ‘Name of client, etc.’, and ‘Primary Sponsor’ were added for the ‘Other clinical research (*)’ field
  • The input field of ‘IPD sharing’ was added in the initial application/change application for the ‘Other clinical research (*)’ field
    (*) Observational studies, surgery, procedures, etc.

April 2020: Comparing Guidances on COVID-19 Disruptions of International Clinical Trials

On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”)Switzerland’s Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”)Health Canada, and Singapore Health Sciences Authority (“HSA”).

Earlier, on April 02, 2020, a comparative chart was published summarizing the guidance documents issued by FDA, EMA, MHRA and PMDA.

The comparisons include initiating a new clinical trial, continuing a clinical trial, any changes (amendments) to a clinical trial, informed consent changes, study visits, COVID-19 screening procedures, monitoring
activities, investigational product distribution and study reporting.

March 2019: Japan Regulatory Update

UMIN-CTR now supports TRDS 24

March 11, 2019: UMIN Clinical Trial Repository(UMIN-CTR) shares registered trial data with WHO International Clinical Trials Registry Platform(ICTRP). ICTRP has revised its standard data set to version 1.3.1(WHO Trial Registration Data Set, Version 1.3.1), that includes detailed description of trial results. UMIN-CTR started supporting the new data set from March 11, 2019. To meet the registry criteria, registrants should fill up trial result field when they update their trial records since 12 months after the follow-up period ends.

Continue reading “March 2019: Japan Regulatory Update”

July 2018: Japan Regulatory Updates

Continue reading “July 2018: Japan Regulatory Updates”

June 2018: Japan Regulatory Updates

HBD has a workgroup focused on moving Japanese and U.S. clinical study sponsors and regulatory agencies toward the use of a single global clinical trial protocol for evaluating cardiovascular devices rather than parallel country-specific protocols. Continue reading “June 2018: Japan Regulatory Updates”

May 2018: Japan Regulatory Updates

An HBD workgroup compared Japanese regulations, U.S. FDA regulations, existing international standards, and guidelines related to good clinical practices, and found no major differences in the fundamental criteria for ethical clinical research. Continue reading “May 2018: Japan Regulatory Updates”