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-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
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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
The Ministry of Health, Labor and Welfare (MHLW) on November 22 proposed two rules designed to address windfall price rises enjoyed by cheaply sold generics - a problematic fallout from the current three price-band grouping rule.The rules formed part of…
A raft of new medicines will be added to Japan’s NHI price list on November 19, with a key reimbursement…
Combined sales of eight major Japanese drug makers grew nearly 26% year on year in April-September, pushed up by the acquisition of Shire by Takeda Pharmaceutical. Even excluding the industry leader, though, seven firms still collectively eked out a slight…
Indian generic maker Lupin is casting off Kyowa Pharmaceutical Industry, which it acquired in 2007. Forking over 57.4 billion yen…
As Japan gears up for its next drug pricing reform in April 2020, Shoji Kono, director of the National Federation…
Pharmaceutical sales per rep in Japan, a yardstick for “productivity” at drug makers, reached a record 172 million yen in FY2018, up 20 million yen from five years ago, as companies continue ramping up their job-shedding drive in a bid…
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…
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…
While the digital transformation may only be in its infancy in the pharmaceutical industry, the winds of change are here. It’s only a matter of time until customers and patients demand a higher level of service, experience, and connectivity from…