Notifications and Guidelines Related to MIHARI

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
PSB/PED Notification No. 0718-1 PSB/PSD Notification No. 0718-1 July 18, 2024 (MHLW)	Partial Revision of the “Procedures for Developing Post-marketing Study Plans for Drugs”[237KB]   (note)The contents of the Administrative Notice (August 15, 2024）have been reflected.	「医薬品の製造販売後調査等の実施計画の策定に関する検討の進め方について」 の一部改正について[312KB] 「「医薬品の製造販売後調査等の実施計画の策定に関する検討の進め方につい て」の一部改正について」の訂正について [312KB]
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]

 

Notifications related to Risk Management Plan (RMP)

Notifications issued from the Ministry of Health, Welfare and Labour (MHLW) related to Risk Management Plan (RMP) are listed here.

 

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