GMP (Good Manufacturing Practice) (compliance) inspectionsGMP(適合性)調査GMP inspectorsGMP調査員Sampling (samples); collection of samples収去(品)
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Elective Care Scheme for LLPs長期収載品 選定療養制度July 19, 2024
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G1/G2 RuleG1/G2ルールMarch 9, 2018
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New PMP Criteria新薬創出加算の新要件March 9, 2018
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Cost-Based Method原価計算方式July 27, 2017
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Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…