Japan's medicines safety system is administered through the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). PMDA provides extensive post-marketing safety information and operational resources.
Core official resources
- Provision of Information Regarding Post-marketing Safety — PMDA's central post-marketing safety information hub.
- Safety Information Regarding Drugs — package inserts, Yellow/Blue Letters, risk communications, precaution revisions and other drug-safety information.
- MHLW Pharmaceuticals and Medical Devices Safety Information — periodic MHLW safety information based on collected safety data.
- PMDA Medical Safety Information — safety information addressing repeatedly reported incidents and important precautions.
Practical use
English-language PMDA pages are useful for orientation, but Japanese-language source material is often more complete and should be checked for jurisdiction-specific operational work.