Nov 18 , 2021. 10 hours ago – 23:50 KYODO NEWS
TOKYO – Japan will establish a system to allow vaccines and drugs to be granted approval in emergency situations once their safety has been verified, making the screening process even shorter than under the fast-track system, government sources said Wednesday.
The plan, to be finalized by the end of the year, comes amid criticism that Japan lagged behind other countries in approving drugs and vaccines to deal with the coronavirus pandemic. Currently, drugs are required to pass both safety and efficacy tests before they can be approved.
Under the proposed new system, if the efficacy of a drug approved for emergency use cannot be confirmed within a set time limit, its approval will be revoked, according to the sources.
A related bill will be submitted to an ordinary Diet session next year, they said.
Once a pharmaceutical company files a new drug application after conducting clinical trials on humans to verify a drug’s efficacy and safety, it usually takes around a year to obtain approval from the Ministry of Health, Labor and Welfare.
COVID-19 vaccines developed overseas were approved under the fast-track system that allows the review process to be simplified using data from countries where the vaccines were already being administered.
But even under this system, approval for the vaccines in Japan lagged up to 5 months behind the United States and Europe.
In the United States, the use of unapproved drugs and medical devices can be allowed under the Emergency Use Authorization framework.