コモン・テクニカル・ドキュメント : CTD : 医薬品の承認申請のための国際共通化資料

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Summary, etc.：: ICHにより作成された国際共通化資料(CTD）。品質・非臨床・臨床ガイドラインに基づき作成された医薬品の承認申請資料を現行の(Provided by: 出版情報登録センター（JPRO）)

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医薬品の承認申請のための国際共通化資料コモン・テクニカル・ドキュメント(CTD) 目次
−和英/Japanese and English−
CTDの一般情報/ 1
Common Technical Document(CTD)Implementation Coordination Group Presenting General Information of CTD/ 4
通知(平成13年6月21日医薬審発第899号):「新医薬品の製造又は輸入の承認申請に際し承認申請書に添付すべき資料の作成要領について」 −「医薬品の承認申請のための国際共通化資料」−/ 17

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