Gifu, Japan

Global Regulatory Science

Research Interests

Academia, research organizations and pharmaceutical industries should cooperate with regulatory bodies such as US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) and then take a great social responsibility to produce innovative medicines that provide new treatments to the patients in the disease area with unmet medical needs (UMN). In order to provide innovative medicines, the evaluation criteria between applicant (mainly pharmaceutical companies) and authorizer (regulatory bodies) should accord under the processes of application and approval. The Global Regulatory Science (GRS) aims to study the regulatory science through analyzing cases and transitions of criteria in the world and to create the evaluation criteria for drug development and approval. We will examine the theoretical framework of evaluation criteria for approval of innovative medicines and will predict its change. These knowledge and prediction will put the drug development into effect quickly and smoothly. We will offer opinions and suggestions to patients or society in order to provide better medical options.

Research Objectives
  1. To analyze regulatory bodies’ decision for the authorization of drugs and medical devices
  2. To analyze regulatory bodies’ theoretical framework
  3. To analyze pharmaceutical companies’ clinical development and pharmaceutical affairs strategies
  4. To investigate the comparative evaluation criteria between divisions in regulatory bodies
Research Results
  1. Tsukamoto K, Matsumaru N. Current Approaches for Education and Research of Regulatory Science in Europe and Unites States. Regulatory Science of Medical Products, (in press).
  2. Tsukamoto K. Development of Novel Pharmaceutical Agents for Alzheimer’s Disease: The Impact of Regulatory Initiatives in Japan and United States. Clinical Therapeutics, 37(8), 1652-1660 (2015).
  3. Tsukamoto K, Takenaka T. An Analysis of the Current State of Regulatory Science Research and Education in the United States. Regulatory Science of Medical Products, 5(1), 103-110 (2015).
  4. The 3rd Gifu Innovation Lecture, international symposium entitled “What we can do for pediatric drug development – Past, Present, and Future -” was held on October 8, 2015 (hosted and organized).
  5. Matsumoto T, Mori D, Onishi T, Waki T, Matsumaru N, Tsukamoto K. The effect of FDA guidance on the development of anti-diabetic drugs in Japan. 1st Regulatory Science Forum for next-generation researchers, 2015.
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