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Post-Marketing Requirements for Anticancer Drugs Approved in Japan, 2001-2024: A Cross-Sectional Analysis
Aina Tsuno1, Hiroe Kitagaki1,2, Hideki Maeda1
1Regulatory Science, Meiji Pharmaceutical University, Tokyo, Japan.
CPT: Pharmacometrics & Systems Pharmacology
|July 29, 2026
Summary
Post-marketing requirements (PMRs) for anticancer drugs in Japan primarily focus on safety monitoring. Few require dose optimization studies, suggesting a need for enhanced evidence generation for dose selection.
Area of Science:
- Oncology
- Pharmacovigilance
- Regulatory Science
Background:
- Innovative anticancer therapies are rapidly developed and approved, often with limited initial clinical data.
- Post-marketing requirements (PMRs) are crucial for supplementing safety and efficacy data after drug approval.
- The landscape of PMRs for anticancer drugs in Japan requires detailed characterization.
Purpose of the Study:
- To characterize the status, content, and trends of PMRs for anticancer drugs approved in Japan.
- To analyze the types and frequency of PMRs imposed on anticancer agents.
Main Methods:
- Retrospective review of regulatory documents for anticancer drugs approved in Japan (2001-2024).
- Extraction and analysis of data on drug characteristics and associated PMRs.
- Temporal trend analysis of PMR assignments.
Main Results:
- 328 out of 471 (69.6%) anticancer drugs approved in Japan required at least one PMR.
- A significant increase in PMR assignments was observed after 2011.
- Risk management plans (56.1%) and all-case surveillance (32.5%) were the most common PMRs; only 2.6% involved post-marketing clinical trials, with one for dose optimization.
Conclusions:
- PMRs for anticancer drugs in Japan are heavily weighted towards safety monitoring.
- There is a notable gap in post-approval evidence generation for dose setting and optimization.
- Further regulatory focus may be needed to enhance evidence-based dose selection for anticancer therapies in Japan.
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