On April 1, The Ministry of Health, Labor and Welfare (MHLW) issued a notification allowing institutional review board (IRB) to hold meetings online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.

MWHL relaxes Inspection Rule

Normally, Japan has a “30-day inspection rule” for clinical trials. This limits sponsors from starting a clinical trial until 30 days after the submission of their first trial filings for either new molecular entities (NMEs), new combination drugs, or drugs with with new administration routes. The 30 days interval  is set so that the Pharmaceutical and Medical Device Agency (PMDA) can inspect the clinical site. However, due to COVID-19, the ministry now allows sponsors to start COVID-19 trials withoutout waiting 30 days. 

IRB Virtual Meetings for COVID-19 clinical trials

The Ministry  further eases clinical trial procedures by allowing virtual meeting online or via emails to accelerate IRB discussions. However, the MHLW requires parties concerned to compile and store records pertaining to how they were held and why.

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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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