POLICY BRIEF article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1591433
This article is part of the Research TopicReviews in: Regulatory Science 2024-2025View all 5 articles
Trends in Good Laboratory Practice studies submitted for the marketing authorization of pharmaceuticals in Japan
Provisionally accepted
Yusuke Oku*
Hitoshi Someya- Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Pharmaceuticals and Medical Devices Agencies (PMDA) receives the non-clinical safety studies following Good Laboratory Practice (GLP) for the marketing authorization of medical products.• Here we analyzed the trends of GLP-compliant non-clinical studies (GLP studies) submitted to PMDA from FY2017 to FY2023. Geographical analysis of the origin of studies revealed that the share of Japanese studies slightly decreased over years, reflecting the drug lag/loss in Japan. This was supported by the analysis of the time from the completion of GLP studies to submissions. • Importantly, studies from China and Taiwan were emerging, reflecting the active drug development in China, which is not the adherent to the OECD Mutual Acceptance of Data (MAD). We also discuss the PMDA's policies on the GLP studies conducted in non-MAD countries.
Keywords: Good Laboratory Practice (GLP)1, non-clinical safety study2, Pharmaceuticals3, regenerative medical products4, Organisation for Economic Cooperation and Development (OECD)5, Mutual Acceptance of Data (MAD)6, non-MAD country7
Received: 08 Apr 2025; Accepted: 25 Jun 2025.
Copyright: © 2025 Oku and Someya. 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: Yusuke Oku, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.