Abstract
As mentioned by the Pharmaceuticals and Medical Devices Agency, the risk management planning should start with the development phase and continue to the post-market phase throughout the lifecycle of medicinal products. The post-marketing safety risk management officially started in Japan at last, followed by the notification “On Guidance of Risk Management Plan of Pharmaceuticals” dated April 2012, and a number of the safety risk management plan documents for new medicines have become available in public domain. The evidence body of non-clinical and clinical data to determine a large portion of safety specifications of medicinal products has been derived through the safety evaluation processes of their pre-authorization development phases, however, the discussion on the approaches of developmental safety data collection and assessment has been sparse in Japan. This review outlines the systematic safety evaluation processes for development phases, in reference to the report of CIOMS VI Working Group “Management of Safety Information from Clinical Trials” and the proposal from the PhRMA Safety Planning, Evaluation, and Reporting Team.
