LEXICON
No.125 September 10, 2012

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

The amended Pharmaceutical Affairs Law (PAL; 薬事法), which went into full effect on April 1, 2005, divided post-marketing surveillance (PMS; 市販後調査), which had been conducted in accordance with the GPMSP (good post-marketing surveillance practice) standards (医薬品の市販後調査の基準), into 1) post-marketing drug...

To read the full story

LEXICON

By Reiji Anasako

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…

By Tatsuya Otsuka

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…

By Reiji Anasako

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…

By Yoshinori Sagehashi

As Japan heralds the new imperial era of Reiwa, Eisai CEO Haruo Naito sat with Jiho to look back on…

By Takashi Ebisawa and Tatsuya Otsuka

Japan’s generic market is hitting a plateau soon. Incentive measures rolled out by the government since 2002 have driven its…

By Yoshinori Sagehashi

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…

By Philip Carrigan

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…