LEXICON
No.19 November 1, 2010

Early post-marketing phase vigilance (EPPV)
市販直後調査
Post-marketing surveillance (PMS)
市販後調査

Drug marketing authorization holders (医薬品製造販売業者) are required to conduct post-marketing surveillance (PMS: 市販後調査) in accordance with the Good Post-marketing Surveillance Practice (GPSP: 医薬品の製造販売後の調査及び試験の実施に関する基準) and ensure the safe use of drugs in accordance with the Good Vigilance Practice (GVP: 製造販売後安全管理の基準) after...

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