Transcription of 平成29年度 アジア諸国医薬品・医療機器規制情報収集・分析 …
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平成29年度 アジア諸国医薬品・医療機器規制情報収集・分析 …
2I 3I 28 PMDA i ii iii iv v vi
ACTD（The ASEAN Common Technical Dossier for the Registration of Pharmaceuticals for Human Use）は、上記取り組みを 踏まえてASEAN諸国で合意され、2009年1月から施行された、ASEAN諸国の行政庁に「ヒト用医薬品」の薬事申請を行う際の、申請様式のガイド
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