Regulatory Affairs Services in Japan

The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory body that operates in collaboration with the Ministry of Health, Labour, and Welfare. The PMDA plays a central role in Japan’s regulatory affairs processes by protecting public health through the evaluation of product safety, effectiveness, and quality of pharmaceuticals and medical devices. It is responsible for developing detailed regulatory frameworks, conducting thorough assessments, and ensuring rigorous post-market safety surveillance .