Proposed Actions for Improved Effectiveness and Efficiency of Risk Management Activities for Pharmaceuticals

Abstract

Almost a decade has passed since the implementation of the risk management plan system in Japan, which aims to help plan and conduct comprehensive risk management activities for pharmaceuticals in the post-marketing stage. To improve effectiveness of this system, we need to examine a mechanism that does not impose undue burden on relevant parties, along with enhancing the contents of individual risk management activities, and to maintain a fine balance. For this purpose, it is necessary to evaluate effectiveness of risk minimization activities as well as burden on relevant parties, and to optimize the activities based on the evaluation. At the same time, enhancement of routine pharmacovigilance activities is important. In this paper, we present an outline of the proposed actions for improved effectiveness and efficiency of risk management activities for pharmaceuticals, which were prepared based on the study findings by and discussions among relevant parties on each of the issues under a research grant from the Japan Agency for Medical Research and Development (AMED).