Objective : To have future perspective on postmarketing surveillance (PMS) in Japan
Design and Methods : Several general principles considered of particular importance to PMS in Japan are outlined as follows ; (1) to help and encourage the voluntary cooperation with all health professionals, (2) to make data open to public but not exclusively to regulatory authority, (3) to conduct non-interventional or observational study which monitors the patients representative of the general population of users and (4) to encourage the development of multi-scheme system.
Results and Conclusion : It is concluded that existing schemes may be improved and some may be newly created as follows ; (1) as to voluntary reporting system, the reports should be collected from all health professionals in all clinics and hospitals, (2) a new system similar to Prescription-Event Monitoring (PEM) in UK may be worth trying to establish in Japan because medical costs including those of drugs are itemized in monthly claims for individual patients made by all Japanese clinics and hospitals, (3) hospital-based database may be further developed and (4) a system for case registration to conduct high-quality case-control studies to detect rare adverse reactions may be newly created.