I am currently a Director at the Office of Cellular and Tissue-based Products at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2008, I joined PMDA as an officer in the Office of Compliance and Standards where I was also a secretariat for the Japanese Pharmacopoeia till 2012. I am in charge of a wide range of activities, from cell/gene therapy products, tissue-based product and biologics product approval reviews to post-market surveillance. I participated as Ministry of Health, Labour and Welfare (MHLW) and the PMDA topic leader for the development of ICH guidelines and Annexes on “Evaluation and Recommendation of Pharmacopoeial Texts for use in the ICH Regions (Q4B)”. Prior to joining PMDA, I was a research fellow at the University of Calgary, Canada from 2001 till 2005 and National Center of Neurology and Psychiatry (NCNP) Tokyo, Japan from 2005 till 2008.