Organization for University Research InitiativesWaseda University


Institute for Medical Regulatory Science



Director : Mitsuo UMEZU
Professor,Faculty of Science and Engineering

Research theme

Creation of a secure and safe society through a bird’s-eye research project with a non-clinical, evaluation-type recycling model of advanced medical equipment at its core.

Overview of research

This institute creates “medical regulatory science (RS)” which has a new integrated systems science that combines rapidly-progressing natural sciences such as medicine, science and engineering, pharmacy, etc. with diversifying humanities and social sciences in order to realize the university research initiative of Waseda University “Realization of safety and security and improvement of the quality of life in the 21st century”. The objective of this institute is to establish safe and expedient clinical application of highly advanced medical technologies for patients’ peace of mind.
The RS concept proposed by Dr. Mitsuru Uchiyama in 1987 is a world-class concept and has the ‘regulatory science’ aspect that gives a scientific basis to regulatory policies and the ‘evaluation science’ aspect which is different from existing basic science and applied science. However, although subsequently RS has received attention in many fields, the interpretation of the concept is not uniform and its academic structure as a science has still not been formed. After the Great East Japan Earthquake in March 2011, the 4th Science and Technology Basic Plan of Japan announced in August the integrated promotion of “science, technology and innovation (STI) policies” positioning life innovation as a major pillar to prepare for the hiper-gerontological society to come. This plan also indicated the importance of RS taking into account the Fukushima Daiichi Nuclear Power Station accident. To realize the academic structure of RS as a science for constructing new relationships between ceaselessly progressing science and technology is the most important issue that has been assigned to us.
We define medical RS as “an evaluation, forecasting, and decision-making science” for harmonizing and coordinating advanced sciences and technologies related to health and medical care in the 21st century (pharmaceuticals, medical devices, and regenerative medicine) with people and society to bring about true advantages and happiness for patients, and a multi-trans-inter-disciplinary science that is a new creative science combining the natural sciences and humanities and social sciences. The final objectives of medical RS are to “provide the latest effective and safe pharmaceuticals, medical devices, and regenerative medicine to patients” and the foundation of all of those objectives is bioethics. In order to build the academic structure for RS, a pluralistic and inter-disciplinary framework for the natural sciences and humanities and social sciences which encompasses many academic fields is essential.
We have founded this institute with the aim of pooling the wisdom of Waseda University in the humanities and sciences in order to promote research into and build an academic structure for medical RS as a science that creates new relationships between cutting-edge medical technologies and people and society in the 21st century.

Research plan

In November 2014 major revisions were made to the Pharmaceutical Affairs Act for the first time in 70 years and it was renamed the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices . Against this background, this institute will conduct research mainly into pharmaceuticals, medical equipment, and regenerative medicine.
In the full life cycle of the fields in the previous paragraph from research and development to examination, manufacturing and sale, this institute will forecast, evaluate, and weigh the risks and benefits based on non-clinical trials, clinical trials and research, aim to achieve an optimal design by reducing the risks and expanding the benefits, and conduct research that leads to a basis for decision-making that depends on scientific rationality and social rationality in the context of uncertainty and asymmetry in medicine and medical care. Moreover, we will conduct ethical, legal and social research in order to build new relationships between rapidly progressing science and technology and humans and society.
Furthermore, we will conduct research into evaluation, forecasting, and decision-making regarding costs and benefits in insurance examinations. In order to build systems for health technology assessment and ensure the continuity and consistency of the risks/benefits/costs, we will conduct research into the relationship with not only the revised Pharmaceutical Affairs Act but also other laws related to medical matters such as the Insurance Act, Medical Care Act, and Medical Practitionersf Act, etc.
Moreover, we will conduct research into the relationship between innovation and regulation. We will research about the dynamic chain of regulation from the perspective of innovation and risks in terms of benefits and costs. We will conduct research related to the value central to humans of not only human life but also survival, and the change in value from “development-orientedh to “safety and security-oriented.h
In parallel with that, we will engage in international harmonization activities with global ecosystems as the key concept, and conduct research into the standardization of approval review standards in the ICH, ISO, etc.
In this institute we will conduct research into the medical technologies supported by society and the citizens, encouragement of the independent participation of the citizens in medical technologies, interactive communication, citizen-participation type technology assessments, consensus conferences, etc.
In addition, we will conduct research into forecasting, evaluation, and decision-making targeting artificial objects (“thingsh and hsystemsh created by humans) with the objective of solving human and social issues arising from artificial objects made with science and technology that is related to health and medical care in the 21st century.
In the process of executing the above projects, we will realize an academic structure for medical regulatory science that enables a meta-paradigm change, and carry out human resources development.


Hiroshi Kasanuki


Shiro Segawa (Professor, Faculty of Political Science and Economics)
Haruko Noguchi (Professor, Faculty of Political Science and Economics)
Waichiro Iwashi (Professor, Faculty of Law)
Katsunori Kai (Professor, Faculty of Law)
Hironori Higashide (Professor, Faculty of Commerce)
Hironori Ayabe (Professor, Faculty of Science and Engineering)
Akinori Komatsubara (Professor, Faculty of Science and Engineering)
Atsuo Takanishi (Professor, Faculty of Science and Engineering)
Shinji Takeoka (Professor, Faculty of Science and Engineering)
Shinichi Suzuki(Professor,Faculty of Human Sciences)
Hiroshi Iseki (Professor, Faculty of Science and Engineering)
Kiyotaka Iwasaki (Professor, Faculty of Science and Engineering)
Megumu Yokono (Associate professor, Faculty of Social Sciences)
Takashi Hasuike (Associate Professor, Faculty of Science and Engineering)
Yuki Matsuhashi (Research Associate, Faculty of Science and Engineering)
Hiroyo Karube (Assistant professor, Faculty of Science and Engineering)
Ktsuhisa Sakaguchi (Researcher, Faculty of Science and Engineering)
Hiroyuki Ishii (Junior Researcher, Faculty of Science and Engineering)
Akira Kawamura (Assistant professor, Faculty of Political Science and Economics)
Yusuke Tsuboko(Research Associate)
Takanobu.Yagi(Researcher, Faculty of Science and Engineering)

Fumika Aoki(Guest Researcher)

Adjunct Researcher

Shinichi Osaka
Itsu Sen
Masayuki Yamato
Atsushi Aruga
Hitoshi Kasegawa
Ken Masamune
Yoshihiro Muragaki
Massimiliano Zecca
Fumika Aoki
Akira Onomura
Yuki Kawase
Chikako Konoura
Naoto Nakamura
Kazuo Yano
Akira Kokubo
Kazuko Sorimachi
Wataru Taguchi
Nobuyuki Hanamura
Masahiro Echigo
Kazuo Iijima
Taisuke Ikawa
Hiroshi Ohtsu
Tsugiko Kato
Yukiyoshi Kawamoto
Mari Kobayashi
Kazuhiro Sase
Kenichiro Tsuyuki
Yoshikazu Nakayama
Yutaka Hikichi
Yutaka Matsui
Keisuke Matsumoto
Mitsuko Mouri
Toshitaka Yajima
Fumiaki Ikeno
Kuniko Shoji
Nobuyuki Sekine
Ryota Kitawaki
Masayoshi Saito
Ryoji Otsu
Yu Amada
Hiroyo Karube
Shoji Kuniko
Yusuke Nomura
Ban Tomoaki
Shida Takuya
Yamawaki Masahiro
Inoue Tomoko
Tanaka Yutaka
Jokura Yoji
Haishima Yuji
Uematsu Miyuki
Sakota Hideyuki
Okamoto Yoshihiro
Miyajima Atsuko
Nakaoka Ryusuke
Otake Masanori
Kamio Tadashi
Kojima Shigehiro
Shukuzawa Kota


E-mail:[email protected]

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