Dr. Haruhiro Okuda is Honorary Director General of National Institute of Health Sciences (NIHS). After obtaining Ph.D degree in medicinal chemistry from University of Tokyo, he joined the Pharmaceuticals and Medical Devices Evaluation Center, the predecessor of PMDA. From 2002 to 2020, he worked for NIHS, and served as Head of Division of Organic Chemistry, Head of Division of Drugs and Director-General of NIHS. He worked to harmonize regulation on quality of chemical drugs for over 10 years as a member of ICH. He also works to harmonize Pharmacopoeias of Japan, EU, and the USA as a PDG (Pharmacopoeia Discussion Group) member. He has now worked for Pharmaceutical and Medical Device Regulatory Science Society of Japan.