On Dec. 27, Sankei Shimbun learned the full details of the “emergency approval system for pharmaceuticals,” which the government aims to establish to quickly approve drugs in times of emergency. Under the proposed system, the government will be able to approve drugs if their efficacy can be assumed even before the final results of clinical trials are available.
The emergency approval system is based on the lessons learned by the government from the nation’s delay in rolling out COVID-19 vaccines. The proposed framework is designed to be activated in the case of such emergencies as nuclear accidents, radioactive contamination, and bioterrorism in addition to infectious diseases.
A bill to amend the Act on Securing the Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices will be submitted to the ordinary Diet session next year. (Abridged)