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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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 Calculation 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
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Special expansion re-pricing (Huge-seller re-pricing)特例拡大再算定（巨額再算定）March 4, 2016
Forging ahead with its new three-year business plan, Chugai Pharmaceutical enjoyed rosy earnings in the first half of 2019, bolstered by the outperformance of the Hemlibra (emicizumab) hemophilia drug and its I/O star Tecentriq (atezolizumab). But with a biosimilar onslaught…
Generic drug makers are making greater efforts to disclose more information on their products after years of repeated requests from doctors and medical institutions, which want to better ascertain their quality and stability of their supplies.Ohara Pharmaceutical has been disclosing…
Riding on the back of an improved regulatory environment in China, major Japanese drug makers are moving to expand their businesses in the world’s second largest pharma market. Companies are pumping up their new drug pipelines, while forging solid sales…
As Japan heralds the new imperial era of Reiwa, Eisai CEO Haruo Naito sat with Jiho to look back on…
Japan’s generic market is hitting a plateau soon. Incentive measures rolled out by the government since 2002 have driven its…
Some seven years in the making, Japan’s Ministry of Health, Labor and Welfare (MHLW) finally rolled out a cost-effectiveness assessment…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…
Jascha Heifetz, widely regarded as one of the greatest violinists of all time, was once stopped, on 57th Street in Manhattan, by a pedestrian asking, “Could you tell me how to get to Carnegie Hall?” Heifetz pondered the question for…