The PMDA is an incorporated administrative agency that was established by the Ministry of Health, Labour and Welfare (MHLW) to improve the quality, efficacy, and safety of medical
products, including pharmaceutical products and medical devices, in Japan.
The PMDA has three key functions: Relief Services for Adverse Health Effects, Product Reviews, and Post-marketing Safety Measures, which are carried out under the comprehensive risk management framework referred to as the Safety Triangle. There is no other public agency that performs these three functions as an integrated system anywhere else in the world. The PMDA is contributing to the improvement of the public health by accelerating patient access to safer and higher-quality medical products based on regulatory science.