Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
Japan Emergency Approval System
Yuji ARAKAWA
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JOURNAL FREE ACCESS

2023 Volume 13 Issue 1 Pages 39-46

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Abstract

Since the outbreak of the COVID-19, emergency pharmaceutical review systems have been utilized in countries around the world for the early application of therapeutic drugs and vaccines. In Japan as well, multiple therapeutic drugs and vaccines have been rapidly approved by utilizing the special approval system, but in order to address the issue that it cannot be applied to drugs developed in Japan, May 20, 2022, an emergency approval system was created due to the revision of the Pharmaceuticals and Medical Devices Act. In the future, it will be important to utilize this system in emergencies and quickly commercialize medicines.

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© 2023 Society for Regulatory Science of Medical Products
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