Number of BTC and OTC drugs approved by PMDA Japan FY 2013-2022
In the fiscal year 2022, the number of behind-the-counter (BTC) and over-the-counter (OTC) drugs approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan amounted to 725, down from 916 approved products in fiscal 2013. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working with Japan's health ministry.