title: The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan.
authors.affiliation: Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Chieko
authors.initials: C
authors.lastname: Ishiguro
authors.affiliation: Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Takeuchi
authors.affiliation: Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Uyama
authors.affiliation: Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
authors.forename: Tomiko
authors.initials: T
authors.lastname: Tawaragi
mesh_terms: D016208:Databases, Factual; D011307:Drug Prescriptions / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D057286:Electronic Health Records; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards; D006801:Humans; D007564:Japan / Q000453:epidemiology; D004364:Pharmaceutical Preparations / Q000592:standards*; D017891:Pharmacoepidemiology / Q000379:methods*; D010865:Pilot Projects
chemical_list: D004364:Pharmaceutical Preparations
keywords: pharmacoepidemiology; post-marketing drug safety; regulatory science