ABSTRACT
One year and a half has passed since the implementation of the guideline on drug risk management plan (RMP). Japanese RMP system practically began to work. While a post-marketing surveillance study, which has played the central role in pharmacovigilance activities in Japan, is positioned as a measure to collect information to be used in the application document for re-examination, the environment surrounding pharmacovigilance has dramatically changed, e.g. increased number of spontaneous reports, improved medical information database and expansion of its availability, compared to the situation when the reexamination scheme was incorporated into law 35 years ago. Now we need to examine diversified approaches to improve the traditional method and mindset taking advantage of the advances in information technology. In order that RMP system be implemented effectively as well as soundly, it is important to implement the PDCA (plan-do-check-act) cycle in a timely manner. Also we need to assess the overall balance between the resources for post-marketing risk management activities and the performance obtained by them from the viewpoint of ensuring patients' safety.