GPMSP (good post-marketing surveillance practice)医薬品の市販後調査の基準GPSP (good post-marketing study practice)医薬品の製造販売後の調査及び試験の実施の基準GVP (good vigilance practice)医薬品、医薬部外品、化粧品及び医療機器の製造販売後安全管理の基準
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LEXICON
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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 Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…