The Pharmaceuticals and Medical Devices Agency (PMDA) was established in fiscal year (FY) 2004 to evaluate the quality, efficacy and safety of drugs and medical devices for marketing authorization in Japan. Here, we analyse trends in the new drugs reviewed and approved by the PMDA and Ministry of Health, Labour and Welfare (MHLW) in the 20 years from FY2004.

The authors declare no competing interests. The views expressed in this article are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency.