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CMIC Resources

CMIC Resources

C-CAST: Regulatory Recommendations and Requirements for Cell and Gene Therapy in Japan

This C-CAST covers:

  • Regulatory Framework for Cell and Gene Therapy
  • Initial Regulatory Steps in Japan
  • Tips for Successful Clinical Development in Japan



Kazuhiro Fukuta
Senior Consultant, Head of Regenerative Medicine Group
Consulting Div., CMIC Co., Ltd.

Dr. Kazuhiro Fukuta is a Senior Consultant and the Head of Regenerative Medicine Group, Strategy & Regulatory Affairs Consulting Department, Consulting Division in CMIC. He received his Ph.D. in agricultural chemistry from Kyoto University. He is specialized in science, regulation and clinical development of regenerative medicine, including cell and gene therapies, based on his experiences as a researcher of biochemistry, molecular biology and molecular regenerative medicine at university and his 10 years’ career at a biotech company. He is currently consulting with various Japanese and overseas companies to develop cell and gene therapy products in Japan.


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