- List of Approved Products
- Review Reports: Drugs
- Review Reports: Medical Devices
- Package Inserts (in Japanese)
- Good Review Practice
- Projects Across Multi-Offices in PMDA
- Record of Consultations on Pharmacogenomics / Biomarkers
- Task Force for Advanced Review and Consultation with Electronic Data
- PMDA Risk Communications
- The Yellow Letter / Blue Letter
- Safety Information announced by MHLW
- MHLW Pharmaceuticals and Medical Devices Safety Information
- PMDA Medical Safety Information
- PMDA Request for Proper Use of Drugs
- Risk Management Plan (RMP)
- Other Information (in Japanese)
- MIHARI project
- Regulations (in Japanese)
What is the "MIHARI project"?
As one of the activities for reinforcement and enhancement of the system for safety information collection and evaluation of medical products in the PMDA 2nd midterm plan (2009-13), the project on the use of electronic medical records, etc. for safety measures was launched. This project is the "Medical Information for Risk Assessment Initiative" and also called "MIHARI project". "MIHARI" means "monitoring" in Japanese. PMDA Expert Committee on the use of electronic medical records, etc. was also established as an advisory board for the "MIHARI project" in 2009.
What dose the MIHARI's logo indicate?
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 project.
Why the MIHARI project was started?
What does the MIHARI project address?
- Ensure access to several kinds of electronic health information (i.e. medical records, insurance claim data)
- Develop pharmacoepidemiological methodology to use electronic health information for evaluation of risk for adverse drug reactions
- Develop methodology to use claim data etc. for evaluation of impact of regulatory actions on drug utilization
- Make safety information from post marketing studies electronically available and to create a database
- Expand accessibility to adverse drug reaction data from outside PMDA for research activities
- Develop by FY 2013 infrastructures for access to clinical information databases that include Receipt data, conduct pharmaceutical and epidemiological analyses, and quantitatively evaluate pharmaceutical risks. Specifically, the Agency shall start to make use of the infrastructures on a trial basis in FY 2011, and shall by FY2013 establish a system for conducting investigations on the frequency of occurrence of adverse drug reactions, together with pharmaceutical and epidemiological analyses.
- Computerize information on adverse drug reactions, such as drug use result survey, and build databases in order to make use of computerized information in the development of safety measures.
- Start in FY 2009 to consider utilization of adverse reaction report data and drug use result data by relevant parties for investigative research, starting from FY 2011.
- Construct a system for independently investigating, confirming, and verifying the effects of safety measures, where necessary, starting from FY 2011, in parallel with evaluations conducted by companies