TOKYO: The Japanese government Tuesday adopted a bill to enable rapid pharmaceutical approvals of vaccines and drugs considered effective, in emergency situations including when the novel coronavirus is spreading.
The bill to revise the pharmaceuticals and medical devices law is aimed at speeding up related procedures after Japan lagged behind the United States and Europe in putting COVID-19 vaccines into practical use. It is also designed to strengthen the domestic development of medical products.
The planned emergency approval system will allow medicines and other medical products used overseas to be sold in Japan before clinical trials if their safety is confirmed and their effectiveness is expected.
Under the system, domestically developed products will be allowed to be used before their final clinical trials under the same conditions.
The government will revoke the approvals if it turns out the medical products have no effects within two years of the start of practical use.
Any health damage from products that received the emergency approvals will be compensated for under the existing relief system.
In Japan, COVID-19 vaccines were approved under a special measure to swiftly examine drugs already in use abroad. But the procedures took time because additional clinical trials were necessary.
If the envisaged system had been available, US drugmaker Pfizer Inc.’s COVID-19 vaccine would have been put into practical use in Japan two months earlier, sources said.
Medical products that have been approved in Japan ahead of the rest of the world are not subject to the current special measure.
Shionogi & Co., which has filed for approval of its COVID-19 pill, is therefore asking the government to use a conditional early approval system allowing approvals before the completion of clinical trials.
On Tuesday, the government also endorsed legislation to allow doctors to issue electronic prescriptions by revising laws including the one on medical practitioners.