Japan OKs Bill for Emergency Approvals of Potential Vaccines
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Tokyo, March 1 (Jiji Press)--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.
[Copyright The Jiji Press, Ltd.]