The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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JPMA to Investigate the Status of Application of Japanese PI Waiver
The Japan Pharmaceutical Manufacturers Association (JPMA) plans to run a follow-up survey to look into the status of companies’ operations following a key regulatory guidance in late 2023 to basically waive Japanese PI studies before going into multiregional clinical trials.…
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