日本と欧州の医薬品リスク管理計画における安全性監視活動の比較

抄録

The risk management plan (RMP) system was introduced in Japan in 2013, to enhance the planning and implementation of pharmacovigilance and risk-minimization activities for new drugs. This system often requires additional pharmacovigilance activities. This study was conducted to discuss effective implementation of pharmacovigilance activities aiming to further improve the safety measures for new drugs in Japan. We investigated the RMPs for 19 new active substances approved in 2013 and 2014 both in Japan and Europe, and compared the safety concerns and pharmacovigilance activities for these drugs in Japan and Europe. The safety concerns were not necessarily the same in Europe and Japan, and the total number of safety concerns in Europe was approximately 1.5 times of that in Japan. In Europe, diverse additional pharmacovigilance activities were planned, and additional pharmacovigilance activities were conducted for approximately 40% of all safety concerns, and for around 30% of all known (identified) safety concerns. In Japan, in contrast, additional pharmacovigilance activities were implemented for 80% of all safety concerns, and for 90% of known safety concerns. Our results suggest that it would be possible to collect safety information adequately from a wide range of perspectives in Japan through (1) identifying safety concerns by predicting how the drug product will be used in the clinical setting, (2) positioning and conducting various types of research as additional pharmacovigilance activities, and (3) evaluating whether there are real needs for additional pharmacovigilance activities, and additional pharmacovigilance activities should not be conducted for those safety concerns where additional information can be collected from just routine pharmacovigilance activities.