The PMDA has already taken several actions for acceleration on clinical development of COVID-19 candidate products. In March, the PMDA shortened timelines for starting clinical trials. Under PMDA’s regulation, volunteers of clinical trials had to submit their application of participation 30 days prior to planned starting date of clinical trials. To start trials of products for COVID-19, this 30 days of waiting time is omitted from the timeline that was required by PMDA.  

In April, PMDA takes further steps to speed clinical development of COVID-19 products. An Administrative Notice was issued by MHLW to allow some flexibility in the methods to hold Institutional Review Board (IRB) meetings. IRB is a group that reviews study protocols and related materials to safeguard ethical conduct and volunteers’ rights in clinical trials. An IRB meeting must be held before the start of clinical trials, where usually held-in person at the clinical study site or relevant institution. The Administrative Notice states that IRB meeting can be held in a non-conventional manner such as: emails or virtual meetings. These unconventional ways of meetings are allowed only when IRB meetings must be held immediately to enable a quick start of clinical trials for COVID-19, and in case meetings are held in these ways, their actual process and conduct must be noted in detail.

References:

PMDA pledge to tackle COVID-19 Pandemic

PMDA Takes Further Steps to Speed Up Clinical Development of COVID-19 Products