From pharmacovigilance point of view in Japan, individual case safety reports from industries are important evidence when authorities make decision regarding safety issues, e.g., package insert change. On the other hand, aggregate analysis is not majority due to less infrastructure of available large database than EU/US. Japanese Adverse Drug Event Report database (JADER), which ICSRs have been cumulated, has been tried to use for aggregate analysis. It is not appropriate to use for the purpose of signal management or for primarily deriving safety measures, considering that its source does not cover all the safety information but “spontaneously reported serious adverse reaction”. However, it would be worthwhile to use JADER as a virtual tool to become able to utilize coming large EHR DB and National Claim Database which the authorities have been constructing to be available within few years.

Objective: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.
Method: Among all of the newly approved medicines in Japan in 2010, 12 marketed products in the U. S. are selected. First, to examine the U. S. system, post-marketing safety concerns over those drugs at the time of approval in the U. S. were collected as well as its postmarketing requirements (PMR) which are studies or clinical trials that sponsors are required to conduct under one or more statutes of regulations. Then, the same drugsʼ safety issues discussed as special cautions listed during the approval process in Japan and the corresponding postmarketing safety studies were reviewed.
Result: Both countries have many safety concerns in common, however, in Japan, ongoing studies are only conventional studies, such as post-marketing surveillance studies or all-cases studies, while the U. S. conducts studies to meet each individual requirement need. Ideal post-marketing safety study designs proposed by the task force, seemed beyond sponsors capabilities, particularly with regard to conduct studies with control group, and require involvement of academia external research organizations, or establishment of the national registry system for cancer and other major diseases.
Conclusion: In Japan, Risk Management Plan (RMP) will soon be implemented in 2013, and that is expected to secure patientsʼ safety by the scientific pharmacovigilance plan with the international standard. It is an urgent task to discuss what plan is feasible in Japan and how to make the corporation of industry-government-academia a reality. (Jpn J Pharmacoepidemiol 2012; 17 (1): 55-66)