Criteria for safety evaluation of antimicrobial agents

Principles and basic concepts on the safety evaluation of antimicrobial agentsThe Japanese Society of Chemotherapy criteria for assessment of adverse reactions and abnormal laboratory values associated with antibacterial agents in study subjects [1,2] (hereinafter referred to as ''JSC's current criteria''), have been adopted in many clinical studies from immediately after their publication and are also cited in areas other than antimicrobial agents.Accumulated safety data based on the criteria have been submitted to the regulatory authorities in Japan for marketing approval applications.No inquiries such as uncertainty about the safety evaluations in clinical studies of antimicrobial agents have been made so far; therefore, the criteria seem to be recognized widely, including by the regulatory authorities.However, there is a concern that the JSC's current criteria do not fit the present situation, because in recent new drug development the results of overseas clinical studies