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.

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