Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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Dissolution Test Methods Annexed to ICH Q4B GLs Go into Effect
The Pharmaceutical and Food Safety Bureau's (PFSB) Evaluation and Licensing Division issued a director notification to prefectures on July 26 announcing that “Dissolution Test Methods Annex 7 (R2)”annexed to the ICH (International Conference on Harmonization of Technical Requirements for Registration…
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Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…