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[V2-S5] Present Condition of Regulation for Regenerative Medical Products in Japan
Session Chair(s)
Daisaku Sato, PhD, MPharm, RPh
Director, Compliance & Narcotics Division
Ministry of Health, Labour and Welfare, Japan
High expectations are placed on the regenerative medicine which may lead to a new approach to therapies of diseases that have no cure. Based on a vigorous debate on the way to facilitate practical application of regenerative medicine, the legal framework on the regenerative and cellular therapy products as well as gene therapy products was created through the revision of the Pharmaceutical Affairs Law in 2014. In this session, the present conditions of regulation and review of the regenerative medical products in Japan is discussed.
Speaker(s)
Recent government move regarding regenerative medicine product regulation
Hiroshi Yaginuma, MPharm
Ministry of Health, Labour and Welfare (MHLW), Japan
Quality Aspects of Regenerative Medical Products
Yoshiaki Maruyama, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Cellular and Tissue-based Products
Current Situation on Non-Clinical Safety Evaluation of Regenerative Medical Products
Takuya Nishimura, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Reviewer, Office of Cellular and Tissue-based Products
Tumorigenicity Testing for Regenerative Medical Products
Yoji Sato, PhD
National Institute of Health Sciences, Japan
Head, Division of Drugs
Clinical Trial for Regenerative Medical Products
Ken Sakushima, MD, PhD, MPH
Hokkaido University Hospital, Japan
Specially Appointed Associate Professor, Research and Development Division
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