Currently more than 50% of clinical trial notifications submitted to the PMDA are for multi-national trials. Industry, academia and regulatory authorities have been seeking efficient, streamlined and low-cost ways of conducting clinical development in order to cope with complexity of clinical trials in recent years especially in multi-national settings.
In addition, since 2020, COVID-19 pandemic brought several challenges in clinical development of drugs, such as difficulties for patients and monitors/CRCs in visiting trial sites during the pandemic, need for large-scale trials involving tens of thousands subjects planned and conducted in a very short time for vaccine development.
While, digital transformation (DX) is now called for in various areas of society, the incorporation of online technology in each process of clinical trials (e.g. informed consent, data collection, SDV/monitoring etc.) can be a way to respond to the current challenges. 
The Ministry of Health, Labour and Welfare (MHLW) has been investigating and collecting information on actual cases of clinical trials using online technology including decentralized clinical trials (DCTs) as well as relevant guidelines in Japan and abroad, in order to provide certain guidance/points to consider for ensuring reliability in clinical trials using online technology
In this presentation, such situations will be outlined from the regulator's point of view for further discussion at the symposium.