Regulatory-required post-marketing database studies in Japan could be leveraged to assess important potential risks as well as identified risks.

ABSTRACT:

Background

To investigate the characteristics of post-marketing database studies (PMDS) included in risk management plans (RMPs) across all therapeutic areas in Japan.

Methods

Two researchers systematically and independently reviewed all RMPs listed on the Pharmaceuticals and Medical Devices Agency website from April 2013 to December 2023. PMDS contained in RMPs were identified, reviewed, and summarized by study design, target objectives, and data source. Specific objectives were linked to the data source.

Results

Among 648 RMPs retrieved/reviewed, 85 PMDS were identified from 63 RMPs targeting 138 safety and five effectiveness objectives. Among 85 PMDS, 57 (67.1%) PMDS targeted important identified risk and 29 (34.1%) targeted important potential risk. Cohort studies

SUBMITTER: Yamazaki H 

PROVIDER: S-EPMC12319243 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature