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Japan Adopts Early Approval Scheme For Infectious Disease Drugs

Local Clinical Data Not Required

 
• By Lisa Takagi

Japan has implemented a streamlined regulatory system designed to enable speedier approvals of selected drugs for designated categories of infectious diseases, which does not require Japanese clinical data.

Japan enhances countermeasures against infectious diseases through a faster approval pathway. (Shutterstock)

Japan’s Ministry of Health, Labour and Welfare (MHLW) has implemented a streamlined early approval scheme for selected drugs against designated infectious diseases, as part of broader countermeasures in this area.

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