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
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...
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