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.
The ministry plans to apply the new rules in cases of emergency such as the spread of infectious diseases, nuclear accidents and bioterrorism.
The ministry will confirm the safety of drugs and vaccines under the new rules just as now, but the approval will be given if their efficacy is presumed, even before clinical tests are conducted.
With regard to drugs made overseas, the ministry would be allowed to give approval without clinical tests in Japan if the results of final clinical tests overseas are available.
For example, Pfizer Inc.’s COVID-19 vaccine, which was approved in Japan in February, could have obtained approval about two months earlier if the new rules had applied.
After the ministry gives approval under the new rules, the efficacy will be confirmed under ordinary procedures. If the efficacy proves to be insufficient, the ministry would cancel the approval.
In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.
SUBSCRIBE NOW
