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Japan’s parliament passes bill on emergency licensing of vaccines

Congress Japan recently passed a bill amending the Law on Quality Assurance, Efficiency and Safety of Pharmaceuticals, Medical Devices and Similar Products (also known as the Pharmaceuticals and Medical Devices Law), in that allows for the emergency authorization of vaccines, pharmaceuticals and other medical goods in urgent situations such as when an infectious disease is spreading.

Under the revised law, vaccines and drugs will be approved for emergency approval even before clinical trials have been completed if safety has been confirmed and efficacy can be estimated. Notably, vaccines that are circulating abroad and are assessed to be effective can be licensed for sale in Japan without the need for clinical trials. This will allow for faster vaccine distribution compared to the current specialty drug licensing system.

In addition, the governing law will also create more favorable conditions for the research and development of vaccines and pharmaceuticals by domestic companies, as these products can be licensed while they are still being tested. clinical trial.

On the other hand, this system is also used for emergency authorization of necessary pharmaceuticals and medical equipment in emergency situations that can greatly affect people’s lives and health such as an epidemic. infectious disease or during a nuclear accident. The safety of such goods will be determined using applicable standards.

However, according to the Jiji Press news agency, the emergency authorization will be canceled if the effectiveness of the system is not confirmed within two years of starting to use it.

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