Number of new drugs approved by PMDA Japan FY 2014-2022
In the fiscal year 2022, a total of 573 new drugs were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, 108 of which were newly applied and approved. New drugs refer to medical drugs which are clearly different from existing drugs in terms of active ingredients, ethical combination, administration, indication, dosage forms, or dosage. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working with Japan's health ministry.