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.
Japan Adopts Early Approval Scheme For Infectious Disease Drugs
Local Clinical Data Not Required
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.
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