2016 Volume 6 Issue 3 Pages 355-365
Three years have passed since the Japan Risk Management Plan (J-RMP) has been introduced. The current status and the challenges have been reviewed based on the experiences obtained through the activities of the Clinical Evaluation Committee of the Japan Pharmaceutical Manufacturers Association. Several proposals to reach the ideal situation have been made in terms of 1) the identification of the safety specifications, 2) the review process and 3) the additional pharmacovigilance plans. It was revealed that there is a considerable gap between the PMDA’s and the industries’ point of view for all of the three items. From now, the J-RMPs should be developed focusing most of stakeholder’s attention on how safety profile of the medicinal products adequately evaluated in order to maintain the preferable benefit/risk balance of the products throughout their lifecycle.
