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January 6, 2026
Approximately 5 minutes
Outline of Post-marketing Safety Measures in Japan
Outline of Post-marketing Safety Measures in Japan
1. Purpose of Post-marketing Safety Measures
In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) implements a comprehensive framework of post-marketing safety measures to ensure the continued safety, efficacy, and quality of pharmaceuticals, medical devices, and regenerative medical products after they are launched. These measures are intended to rapidly identify and respond to safety concerns that are not apparent at the time of approval and to promote proper use by healthcare professionals and patients. (pmda.go.jp)
2. Collection of Safety Information
PMDA collects safety information from multiple sources, including:
- Adverse drug reactions (ADRs) and infections caused by pharmaceuticals.
- Adverse events and malfunctions related to medical devices.
- Reports submitted by manufacturers and healthcare professionals. This safety information is stored in a central database for scientific analysis and investigation, forming the basis for detecting safety signals. (pmda.go.jp)
3. Scientific Analysis and Investigation
Once collected, safety data undergoes scientific analysis to evaluate potential safety issues. PMDA develops and applies advanced methods — such as data mining and sentinel institution networks — to enhance timely detection of safety concerns and to support accurate decision-making for safety actions. (pmda.go.jp)
4. Regulatory Linkage and Safety Actions
Findings from safety analyses are reported to the Ministry of Health, Labour and Welfare (MHLW), which may take administrative regulatory actions to protect public health. These actions can include revisions to product labeling, issuance of safety notifications, recalls, or other risk mitigation measures. (pmda.go.jp)
5. Provision of Safety Information
To promote proper use of products, PMDA disseminates safety information widely through its website and other services. This includes:
- Electronic package inserts, product recall notices, and urgent safety alerts.
- Results of adverse event reports for drugs and devices submitted to PMDA.
- Free e-mail alert services delivering the latest safety information to healthcare professionals. These services ensure stakeholders and the general public have access to timely safety data. (pmda.go.jp)
6. Consumer Support Services
PMDA also provides telephone consultation services for consumers regarding the safe use of pharmaceuticals and medical devices, strengthening public engagement on safety matters. (pmda.go.jp)
7. Cooperation with Marketing Authorization Holders
PMDA collects contributions from marketing authorization holders (MAHs) regarding safety measures, encouraging companies to actively participate in post-marketing risk management and safety enhancement efforts. (pmda.go.jp)
Summary
In summary, Japan’s post-marketing safety measures combine systematic data collection, scientific analysis, effective regulatory actions, and proactive communication of safety information to protect public health and facilitate the safe use of medical products. (pmda.go.jp)
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