The universal health care system in Japan is facing a historical turning point as a result of
the increasing fiscal burden, rapidly aging society, and a decreasing population. To …

Background Mechanisms underlying safety events may be heterogeneous and depend on
conditions of development and marketing, including the populations studied in clinical trials …

Background: Prediction and management of drug safety is a global regulatory issue. Safety-
related regulatory actions (SRRAs) are taken mostly when unexpected adverse drug …

While efficient and less onerous for the industry, the globalization of clinical drug
development may lead to limited efforts to optimize drugs for regional conditions. We …

Pharmacoepidemiology involves development of new models to predict safety in the
development stages of pharmaceutical products, development of various guidelines and …

This chapter describes the brief history and recent development of Japanese post‐approval
safety procedures. Two systems of “re‐evaluation” and “re‐examination” were introduced in …

Purpose To evaluate the safety‐related regulatory actions implemented by Japan's
Pharmaceuticals and Medical Devices Agency (PMDA) in 2012. Methods We analyzed …

Measuring the benefits and risks of medicines is the underlying theme whenever the
development, review, and regulation of new medicines are discussed. Workshop …

What is known and Objective Many drugs fail during development. However, detailed
reasons for failure during drug development are almost never disclosed. We focused on the …

Kimura, one of the co-authors of this book, was long engaged in clinical development and
pharmacovigilance activities for pharmaceutical products at several different foreign …