ABSTRACT
The concept of regulatory science (RS) was proposed in 1987 by Dr. Mitsuru Uchiyama. He describes “RS is the science of optimizing scientific and technological developments according to objectives geared toward human health. It is also the science of predictive evaluation. In properly carrying out the mission of regulation, we must engage in appropriate research activities and harmonize technology with society's needs. This can be accomplished only by accurately comprehending and carefully exploiting the characteristics and trends of new technologies, reactions, materials, and substances”. This article describes the development and the present status of RS in Japan, US and EU. FDA (US authority) defines RS as the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products, and considers RS as a useful tool to accelerate the approval of new drugs and their delivery to patients. On the other hand, PMDA (Japanese authority) takes RS as the norms of regulatory activities in assessment and approval of useful drugs to meet the needs of patients. Pharmacovigilance (PV), defined by WHO, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. PV focuses on safety of drugs and, therefore, can be a part of RS which deals with all aspects of pharmaceutical products including efficacy, safety and quality. The occurrence rate of adverse effects leading to death is revealed quite high by the studies in US and in Japan. Prediction and prevention of adverse effects are urgent matter that RS and PV should deal with.