Number of pharmaceutical products approved by PMDA Japan FY 2022, by type
In the fiscal year 2022, approximately 1.9 thousand generic prescription drugs were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, while 573 new drugs were approved. New drugs refer to medical drugs that 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 together with the health ministry in Japan.