Pharmaceuticals and Medical Devices Agency

The Pharmaceuticals and Medical Devices Agency (独立行政法人医薬品医療機器総合機構) (PMDA) is a Japanese corporation, an Independent Administrative Institution, responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function, in many respects, to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines.

The PMDA has been eCTD-compliant at least since July 2017.