Notifications issued from the Ministry of Health, Welfare and Labour (MHLW) and guidelines
Notification issued from the Ministry of Health, Welfare and Labour (MHLW) and guideline related to MIHARI are listed here (Other Japanese versions are here).
| Date | Title | Original in Japanese |
|---|---|---|
| Administrative Notice June 9, 2023 (MHLW) |
Utilization of Medical Information Database in Pharmacovigilance and Its Examples[105KB] | 「医薬品安全性監視における医療情報データベースの活用とその事例」について[750KB] |
| July 31, 2020 (PMDA) |
Development of Basic Principles in Conducting a Validation of Outcome Definitions used in Post-marketing Database Studies[200KB] | 製造販売後データベース調査で用いるアウトカム定義のバリデーション実施に関する基本的考え方[727KB] |
| PSEHB/PED Notification No. 0609-8 PSEHB/SD Notification No. 0609-4 June 9, 2017 (MHLW) |
Basic Principles on the Use of Medical Information Databases in Post-marketing Pharmacovigilance[86KB] | 製造販売後の医薬品安全性監視における医療情報データベースの利用に関する基本的考え方について[234KB] |
| March 31, 2014 (PMDA) |
Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment with Medical Information Databases[614KB] | 医療情報のデータベース等を用いた医薬品の安全性評価における薬剤疫学研究の実施に関するガイドライン[399KB] |