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Significant public health issues caused by adverse drug reactions in the post-marketing phase, such as birth defects by thalidomide, have been well described. Unfortunately, subjects in clinical trials cannot completely avoid severe harm during drug development. TGN1412 in 2006 and BIA 10-2474 in 2016 were withdrawn from development due to severe adverse reactions in first-into-man studies. Thus, monitoring drug safety is important throughout all phases of development. In twenty-first century, minimizing drug development cost and time is a challenge for pharmaceutical companies. When a drug is approved with a smaller size and fewer number of clinical trials, pharmacovigilance and benefit-risk evaluation after marketing need to be sufficiently performed. Underpinned by understanding of the traditional methods of evaluating adverse drug reactions, new developments in IT and computing might well help us to detect drug safety signals earlier, enabling prompt intervention for protecting the rights of subjects and public health.

Frameworks for Evaluating Qualitative and Quantitative Information on Adverse Drug Events throughout Development through to Marketing