Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.

ABSTRACT: The Ministerial Ordinance on Good Post-Marketing Study Practice for Drugs was amended by the Ministry of Health, Labour and Welfare (MHLW) in 2018 to clearly define post-marketing database studies (DBS) as a measure of pharmacovigilance activities for approved medical products in Japan. This review describes and characterizes DBS in the landscape of post-marketing safety/effectiveness investigations of approved medical products in Japan for the past 6 years. New drugs and regenerative medical products approved by MHLW between January 1, 2019, and December 31, 2024, were included (N = 697). Of the total 572 planned post-marketing surveillances, 91 (15.9%) DBS were identified. The percentage of DBS initially decreased from 2019 to 2021 and then increased to 18.9% by 2024. Compared with other

SUBMITTER: Okami S 

PROVIDER: S-EPMC12856056 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature