- Home >
- Services of PMDA >
- Post-marketing Safety >
- Safety Information

- Outline
- Approved Products
- List of Approved Products
- Review Reports of New Product Applications
- Package Inserts Database (in Japanese)
- Regulations and Procedures
- Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drug (PDF)

- Outline
- Safety Information
- MHLW Pharmaceuticals and Medical Devices Safety Information
- PMDA Medical Safety Information
- Other Information (in Japanese)
- Regulations

- Outline
PMDA provides the following safety information regarding pharmaceuticals and medical devices.
- MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI)
- This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers.
- PMDA Medical Safety Information
- Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, information on similar events that have been repeatedly reported and cases leading to notifications for revisions to package inserts are described on the "PMDA Medical Safety Information" site in an easily understandable manner and widely disseminated. Important reminders to encourage safe use of drugs and medical devices to healthcare professionals are included, which have been considered based on the opinions of healthcare professionals such as physicians, pharmacists, nurses, and clinical engineers, specialists such as those in the field of ergonomics, as well as industry organizations such as marketing approval holders of pharmaceuticals or medical devices.
