Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

MIHARI project

What is the MIHARI ?

The MIHARI (Medical Information for Risk Assessment Initiative) is an activity for reinforcement and enhancement of the process and system for collection of safety information and evaluation of medical products, which, by using epidemiological methods, enables a drug safety assessment based on medical information data such as claims for medical fees and electronic medical record data that medical institutions input and accumulate for the purpose of daily medical practices. MIHARI was launched in 2009 with the aim of improving the quality of PMDA's postmarketing safety measures.
This MIHARI's logo is made from crossed 4 arrows colored blue and green. Two blue arrows show two types of data sources (claim data and medical record data) and two green arrows show two types of analysis methods (pharmacopeidemiological analysis and data-mining analysis), respectively. These 4 arrows indicate that various kinds of data are analyzed from many directions in the MIHARI.

Information about MIHARI

For further details about the MIHARI, please refer to the following pages. Please note that some of the following pages contain technical information.


Notifications and Guidelines Related to MIHARI