Japan is planning to establish a new system (Kin-kyu-sho-nin) in case of emergencies that will allow new drugs and devices to be urgently approved without going through an efficacy confirmation process. Under this new approval system, manufacturers of new drugs only need to provide existing safety and efficacy data and show that their product is the only treatment available for a public health crisis. While the existing approval system (Toku-lei-sho-nin) is only applicable to drugs with overseas approval and complete clinical data, the new system enables drugs and medical devices without prior approval to be considered if there are sufficient interim clinical data.
Japan’s revised PMD-Act including the “Emergency approval system” passed the Diet on May 13, which enables the rapid commercialization of medicines in the event of a global pandemic of infectious diseases. The government will soon amend the ordinance to designate additional drugs for the COVID-19 infection.
The Emergency approval system confirms the safety similar to before but allows approval if the efficacy can be “estimated” from the data in the middle of the clinical trial. Until now, in principle, it has been approved after confirming its effectiveness in large-scale clinical trials. However, the new system will enable early commercialization before the completion of clinical trials.
The application of the new system is limited to infectious disease epidemics, emergency situations such as nuclear accidents and terrorism that have a serious impact on people’s lives, and cases where there is no other alternative. Confirmation of validity of such products is required within 2 years, otherwise, the approval will be revoked.