Division of Regulatory Sciences, The Pharmaceutical Society of Japan

What's Regulatory Science

"Regulatory science (RS)" is the science of developing methods to quantitatively and/or qualitatively analyze and understand the causal relations and mechanisms of the substances and the phenomena around us, and measuring their positive and negative effects. Their efficacy and safety are appropriately predicted, evaluated and judged using the methods developed and the results obtained in the RS, finally contributing to public health.

In the field of pharmaceutical sciences, the object of the RS includes pharmaceuticals, foods, living environments, etc. Specific applications for pharmaceuticals are, for example, scientific research and development of test methods to evaluate quality, efficacy, and safety of pharmaceuticals, medical devices, cosmetics, etc. Scientific policy research and development of safety assessment methods of chemicals and microorganisms in foods and living environments are also applied for foods and environments. In addition, generation of data and its evaluation for actual regulatory purposes are all included in the RS.

In addition, scientific policy for research on safety in foods and living environments against chemicals and microorganisms, etc., the development of safety assessment methods, and generation of data and its evaluation for actual regulatory purposes are all included in regulatory science.

Especially, in the clinical application of innovative pharmaceutical products which are developed and manufactured using advanced technology, in the introduction to the market of convenient new chemicals, or for ensuring safety of foods with dietary changes, the scientific and objective evaluation with the RS is the most reasonable way to quickly and safely extend the benefits of these new technologies to society.

In this way, the outcomes of the RS directly and greatly contribute to the maintenance and improvement of public health through ensuring quality, efficacy and safety of medicines and food, and through the maintenance of a good living environment. Therefore, the study of RS is highly expected to be more active in the future.

The flow of the Regulatory Science