The PMDA, or Pharmaceuticals and Medical Devices Agency, is a Japanese regulatory body responsible for ensuring the safety and efficacy of pharmaceuticals and medical devices. Established in 2004, it plays a crucial role in the approval process for new drugs and medical technologies, working to protect public health in Japan. The PMDA conducts scientific reviews, provides guidance to manufacturers, and monitors the safety of products after they are on the market. It collaborates with other regulatory agencies globally, such as the FDA in the United States, to harmonize standards and improve the efficiency of the approval process.