Japan to introduce speedy drug approval for emergencies

Japan Times -- Dec 04
The health ministry has presented an outline for new pharmaceutical approval rules in emergencies, in what it says would make the procedure as speedy as those in Europe and the United States.

Under the new rules revealed Friday, the ministry will ease requirements that therapeutic drugs and vaccines need to meet for regulatory approval and allow the conditional use once it can presume the efficacy of drugs and vaccines.

The ministry will work out details of the new rule by the year-end with an aim of submitting related legislation to next year’s ordinary session of parliament.

Compared with Western nations, Japan took several more months to approve COVID-19 vaccines.

The government had said it would consider new approval rules for emergencies in its basic economic and fiscal policy adopted in June.