ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1565314
This article is part of the Research TopicAdvancement of RWD/RWE Utilization for Enhancing Drug Development and Benefit/Risk AssessmentView all articles
Regulatory-required post-marketing database studies in Japan could be leveraged to assess important potential risks as well as identified risks
Provisionally accepted
Hiroshi Yamazaki1*
Ko Nakajo1Naoki Hirose1Li Yan2
Sun Yeop Lee1Yongjing Zhang2
Hong Qiu3
Chieko Ishiguro4- 1Johnson & Johnson, Tokyo, Japan
- 2Johnson & Johnson (China), Shanghai, China
- 3Johnson & Johnson, Titusville, Florida, United States
- 4National Center for Global Health and Medicine, Tokyo, Japan
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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 Pharmaceutical 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 were the most prevalent study design (74/85, 87.1%), and 74.1% (63/85) included a comparator group. Common target safety objectives included “infections and infestations”, “metabolism and nutrition disorders”, “cardiac disorders” and “vascular disorders”. The Medical Data Vision database was the most frequently used data source for PMDS (32/85, 37.5%) followed by the Medical Information Database Network (MID-NET®) (18/85, 21.2%) and JMDC (9/85, 10.6%) Conclusion: In Japan, PMDS are usually cohort studies with targeted safety objectives. Most studies currently target important identified risk rather than important potential risk and may not make full use of the advantages of PMDS that can include large populations, comparator groups, and that can assess the occurrence of rare adverse events. These results could be informative for pharmaceutical companies planning post-marketing studies as pharmacovigilance activities. Early public availability of PMDS protocols would promote improved study methodology and could potentially improve the scientific value of PMDS in Japan.
Keywords: Post-marketing surveillance, Safety, Regulatory authorities, Database study, Japan
Received: 23 Jan 2025; Accepted: 24 Jun 2025.
Copyright: © 2025 Yamazaki, Nakajo, Hirose, Yan, Lee, Zhang, Qiu and Ishiguro. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Hiroshi Yamazaki, Johnson & Johnson, Tokyo, Japan
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