In response to the fact that approval of the new corona vaccine was delayed compared to overseas, the government revised the law at a cabinet meeting on March 1 to establish a new system for "urgent approval" of vaccines and therapeutic drugs. I decided on a plan.
Regarding the new corona vaccine, the Ministry of Health, Labor and Welfare has applied "special approval" that simplifies the examination procedure, but is it approved in Japan from 2 months to 5 months from the time when the US and EU approved its use? About a month later, there were voices from within the government pointing out delays in clinical trials and approval.
Based on this, in the amendment bills such as the Pharmaceutical and Medical Device Law, which was approved by the Cabinet on March 1, vaccines and therapeutic drugs can be swiftly provided on the condition that there is no alternative in case of an emergency such as an infectious disease epidemic. We are planning to establish a new "emergency approval" system that allows regulatory approval.
Specifically, if the safety is confirmed and the efficacy is estimated by overseas clinical trials or domestic clinical trials in the middle of the process, regulatory approval can be granted.
In addition, regulatory approval is subject to conditions such as setting a deadline within two years and collecting more valid data, and if the validity cannot be confirmed within the deadline, the approval will be revoked.
In addition, the amendment includes the introduction of an "electronic prescription" that enables data to be used to exchange prescriptions that are currently being exchanged on paper.
The government is now aiming to pass the amendment in the Diet.