September 2022: Japan Registry Update

A notice regarding the discontinuation of the Clinical Trial Promotion Center was posted on Japan Medical Association Center for Clinical Trials – Clinical Trial Registry (JMACCT-CTR) on September 08, 2022, and the updates are summarised below:

  • The JMACCT-CTR will be abolished and the eTraining Center for Clinical Trials will be discontinued on January 31, 2023. It is recommended to download various certificates and browsing materials by January 31, 2023.
  • The data extraction from the JMACCT-CTR system is not possible and there is no alternative site.
  • The login to the system will be disabled after March 01, 2023.
  • The newsletter, meeting announcements and other associated operations will be discontinued after March 31, 2023.
  • New registrations on JMACCT-CTR will be accepted only until September 30, 2022.
  • Information updates on JMACCT-CTR will be accepted only until November 30, 2022.

Please click here to go to the original update.

August 2022: Japan Registry Update

A notice regarding the discontinuation of the Clinical Trial Promotion Center was posted on Japan Medical Association Center for Clinical Trials – Clinical Trial Registry (JMACCT-CTR) on August 23, 2022:

On August 23, 2022, at the 6th meeting of the Board of Directors of the Japan Medical Association, it was decided to abolish the Clinical Trial Promotion Center and reorganize its operations. The registration data will be transferred from JMACCT-CTR to the Japan Registry of Clinical Trials (jRCT) before January 31, 2023.

Please click here to go to the original update.

July 2022: Japan Registry Update

A notice regarding ‘Preparation of Change notifications’ is posted on Japan Registry Clinical Trial (jRCT) on July 08, 2022:

According to the notice, for Specific and Non-specific clinical research, it is now possible to make minor changes and non-notification changes to the record. Minor changes and non-notification changes to items of the record can be published in advance, only when the edited items are not duplicated due to these changes.

Please click here to go to the original update.

December 2021: Japan Registry Update

Updated Fields of Japan Registry of Clinical Trials (jRCT)

Below updates were made to the jRCT system on December 14, 2021:

  • For reporting diseases, etc. based on the clinical research method, it is possible to select multiple treatments/diagnoses other than the ones already described, which are considered to affect the occurrence of side effects
  • For “clinical trials”, an input field for the classification of the clinical trial was added, and it was made a required input item
  • Multiple ethics review committees/IRBs can be registered for “Other Clinical Research” and “Clinical Trials”
  • For “Regenerative Medicine Research”, the target items for minor changes have been expanded
  •  The following changes have been made in general. It is now possible to change the setting of the English change history and search results screen, the item display improvement of Date of Approval and Date of first enrollment, and the presence or absence of placebo, blind, and randomization.

Please click here to go to the original update.

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.