Based on the "Redefinition of Mission" published in April 2014 by the Ministry of Education, Culture, Sports, Science and Technology, the Graduate School of Pharmaceutical Sciences, Osaka University ("Grad. Sch. Pharm. Sci., Osaka Univ.”) has decided to promote Regulatory Science (RS). "Grad. Sch. Pharm. Sci., Osaka Univ." was adopted by "Grant for promotion of the practical application of innovative pharmaceuticals, medical devices, and regenerative medicine products", which was supported by the Ministry of Health, Labour and Welfare (MHLW), and were in collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA), the National Institute of Health Sciences, the National Institute of Biomedical Innovation, Health and Nutrition, and the National Cerebral and Cardiovascular Center, etc. This led to the conclusion of a cooperative graduate school agreement with PMDA and NIHS, and the start of full-scale research education and human resource development regarding RS. In addition, personnel exchanges with the MHLW and PMDA were conducted. Furthermore, a new laboratory, named Laboratory of Regulatory Science for Pharmaceuticals and Medical Devices, was launched in April 2018, and a "new six-year pharmacy education system" unique to "Grad. Sch. Pharm. Sci., Osaka Univ." was established from FY2019. In this lecture, I would like to talk about the current situation and future challenges of RS research education and human resource development in academia.