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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