Toru Kawanishi, PhD

Member of International Editorial Advisory Board, GaBI Journal

Certified in Pharmaceutical Sciences
Deputy Director General, National Institute of Health Sciences (NIHS), Ministry of Health, Labor, and Welfare (MHLW), Japan
Advisor, Pharmaceutical and Medical Devices Agency (PMDA), Japan

Dr Toru Kawanishi earned his PhD in Pharmaceutical Sciences from the University of Tokyo, Japan, in 1986 and as a Research Fellow in the Department of Physiology-Anatomy, University of California at Berkeley, USA, in 1988, and in the Department of Cell Biology and Anatomy, School of Medicine, University of North Carolina at Chapel Hill, USA, in 1989.

He joined the National Institute of Health Sciences (NIHS) and the Ministry of Health, Labor, and Welfare (MHLW) in 1978. He worked in the Division of Pharmacology, Division of Pathology, and Division of Biological Chemistry and Biologicals in the NIHS. He was promoted to Head of Division of Biological Chemistry and Biologicals in 2002, became Head of Division of Drugs at NIHS in 2006, and was promoted to Deputy Director General of the NIHS in 2011.

His professional areas of interest focus on the development of evaluation methods of pharmaceuticals including chemicals and biologicals.

Dr Kawanishi is a temporary member of the Pharmaceutical Affairs and Food Sanitation Council in the MHLW and an advisor of reviewing quality and safety aspects of new drugs submitted for registration to the Pharmaceutical and Medical Devices Agency (PMDA). He also chairs the Expert Committees on General Affairs, Drug Formulation, and International Harmonization, each being for the revision of the Japanese Pharmacopoeia (JP) in the PMDA, and attends the Pharmacopoeia Discussion Group (PDG) meeting as a representative of the JP. He was a representative of the MHLW on the ICH-Biotech products topics (Q5A, Q5D, Q5E and Q6B).

Dr Kawanishi is author of more than 220 publications in books and scientific journals.