Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

Scientific Research and Analyses

 PMDA conducts research and reviews of the collected information through scientific analyses, interviews with companies, and discussions with experts, to determine whether any cases require urgent measures, whether the risk/benefit profile is favorable, and what the optimal safety measures are. All these efforts help increase the safety of drugs, medical devices, and cellular and tissue-based products.

 To establish effective safety measures, the product safety staff work together with the review and relief departments as well as the MHLW, as required.

 To improve and enhance safety measures, PMDA takes various approaches such as the introduction of data mining methods (which involve statistical analysis of adverse drug reactions (ADRs) as reported by companies or medical institutions, thereby detecting signals of ADRs that may warrant further investigation), development of Scientific Research and Analyses databases of electronic medical records and its use in order to establish safety evaluation methods based on information other than ADR reports (known as the MIHARI Project), building of a system for evaluating medical device malfunctions, and building of a system for gathering and evaluating data from medical devices subject to tracking.