{"id":6253,"date":"2016-08-02T10:32:31","date_gmt":"2016-08-02T01:32:31","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=fszblog&p=6253"},"modified":"2025-11-12T20:25:04","modified_gmt":"2025-11-12T11:25:04","slug":"pharmaceutical05","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=pharmaceutical05","title":{"rendered":"\u30a2\u30e1\u30ea\u30abFDA\u3078\u306e\u96fb\u5b50\u7533\u8acb\u306e\u7fa9\u52d9\u5316\u307e\u3067\u6b8b\u308a9\u304b\u6708"},"content":{"rendered":"

FDA\u3078\u306eNDA, DMF\u7b49\u306e\u7533\u8acb\u304c\u3001\u5168\u3066e-CTD\u306b\u79fb\u884c\u3059\u308b2017\u5e745\u6708\u307e\u3067\u3001\u6b8b\u3059\u3053\u30689\u304b\u6708\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n

\u305d\u3053\u3067\u3001FDA\u306f\u30018\u67084\u65e5\u306bweb\u306e\u4f1a\u8b70\u3092\u958b\u50ac\u3057\u3066\u3001\u7533\u8acb\u66f8\u985e\u306eeCTD\u69d8\u5f0f\u3078\u306e\u5909\u66f4\u4fc3\u9032\u3092\u3002\u547c\u3073\u304b\u3051\u305f\u3002\u4eca\u56de\u306eFDA\u306e\u8aac\u660e\u8cc7\u6599\u306f\u5225\u6dfb\u53c2\u7167<\/p>\n

FDA\u304c\u3001\u5f37\u8abf\u3057\u3066\u3044\u308b\u3053\u3068\u306f\u3001<\/p>\n

    \n
  1. 2017\u5e74\u30015\u67085\u65e5\u4ee5\u964d\u306bFDA\u306b\u767b\u9332\u3059\u308bDMF\u306f\u3001eCTD\u69d8\u5f0f\u3067\u884c\u3046\u3053\u3068\uff1c\u7d19\u306b\u8a18\u8f09\u3055\u308c\u305fDMF\u306f\u3001\u3053\u306e5\u67085\u65e5\u4ee5\u964d\u306f\u3001FDA\u306f\u53d7\u9818\u3057\u306a\u3044\uff1e<\/li>\n
  2. \u65e2\u306b\u3001FDA\u306bDMF\u767b\u9332\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001eCTD\u69d8\u5f0f\u306b\u5909\u66f4\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u3067\u306f\u306a\u3044\uff1ceCTD\u306b\u5909\u63db\u3057\u3066\u306eFDA\u767b\u9332\u306f\u3001\u4efb\u610f\uff1e<\/li>\n
  3. \u305f\u3060\u3057\u3001\u65e2\u5b58\u306e\u7d19\u8a18\u8ff0\u306eDMF\u3067\u3042\u3063\u3066\u3082\u30012017\u5e745\u67085\u65e5\u4ee5\u964d\u3001FDA\u306b\u63d0\u51fa\u3055\u308c\u308b\u3000DMF\u306eannual\u3000review\u3001amendment\u306f\u3001eCTD\u69d8\u5f0f\u306b\u3066\u3001FDA\u306b\u9001\u4ed8\u305b\u306d\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n
  4. eCTD\u306eFDA\u7533\u8acb\u306b\u5148\u7acb\u3061\u3001FDA\u306e\u4e8b\u524d\u7533\u8acb\u756a\u53f7\u3092\u53d6\u5f97\u3059\u308b\u3000\uff08http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/FormsSubmissionRequirements\/ElectronicSubmissions\/ucm153574.htm
    \n<\/a><\/li>\n
  5. eCTD\u306e\u69d8\u5f0f\u306f\u3001\u201cProviding Regulatory Submissions in Electronic Format \u2014Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications\u3000Guidance for Industry\u201d\u3092\u53c2\u7167\u3000\uff1c\u5225\u6dfb\u8cc7\u6599\uff1e<\/li>\n
  6. \u65e2\u5b58\u306e\u7d19\u306b\u8a18\u8ff0\u3057\u305fDMF\u3092\u30b9\u30ad\u30e3\u30f3\u3057\u3066\u96fb\u5b50\u30c7\u30fc\u30bf\u3068\u3057\u3066\u306e\u63d0\u51fa\u306f\u8a8d\u3081\u306a\u3044\u3002<\/li>\n
  7. \u7533\u8acb\u306b\u969b\u3057\u3066\u306f\u3001\u7dcf\u5bb9\u91cf\u306f10Gb\u4ee5\u4e0b\u3001\u201dGATEWAY\u3000ESG\u201d\u3092\u3068\u3057\u3066\u3001\u7533\u8acb
    \n\u201cProviding Regulatory Submissions in Electronic Format \u2014Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications\u3000Guidance for Industry\u201d\u306e\u8981\u70b9\u306f\u3001\u4e0b\u8a18\u306e\u901a\u308a\u3067\u3059\u3002\uff1c\u5225\u6dfb\u3092\u53c2\u7167\uff1e<\/li>\n<\/ol>\n

    \u96fb\u5b50\u51fa\u9858\u306e\u6709\u52b9\u65e5<\/p>\n

    \n\n\n\n\n
    Submission\u00a0 Type<\/td>\nFDA\u3000guide\u3000\u767a\u52b9\u65e5<\/p>\n

    Final eCTD Guidance Published to FDA\u00a0 Web site<\/td>\n

    		\u96fb\u5b50\u51fa\u9858<\/p>\n

    Date Requirement\u00a0 Begins<\/td>\n<\/tr>\n

    NDA ANDA BLA Master files(DMF)<\/td>\n2015-05-5<\/td>\n2017-05-5<\/td>\n<\/tr>\n
    Commercial IND<\/td>\n2015-05-15<\/td>\n2018-05-5<\/p>\n

     <\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

     <\/p>\n

      \n
    1. \u51fa\u9858\u5f62\u5f0f\uff1b\u3000eCTD\u3000\uff08FDA\u306e\u6307\u5b9a\u69d8\u5f0f (e.g., 1571 or 356h) \u306b\u3066\u96fb\u5b50\u69d8\u5f0f\u306b\u3066\u51fa\u9858\u3001<\/li>\n
    2. \u69d8\u5f0f\u306f http:\/\/www.fda.gov\/AboutFDA\/ReportsManualsForms\/Forms\/default.htm<\/a>.<\/li>\n<\/ol>\n

      \u3092\u53c2\u7167<\/p>\n

        \n
      1. \u6dfb\u4ed8\u3059\u308b\u3000data\u306f\u3001PDF\u5f62\u5f0f\u3067\u6dfb\u4ed8\u3059\u308b<\/li>\n
      2. \u9001\u4ed8\u8cc7\u6599\u306e\u5bb9\u91cf\u306f\u3001\u300010GB\u4ee5\u4e0b<\/li>\n
      3. Version\u7ba1\u7406\u3001\u3000DFM\u7b49\u3067\u3001\u51fa\u9858\u6e08\u307f\u306eDMF\u3092\u3001\u7f6e\u304d\u63db\u3048\u308b\u5834\u5408\u306f\u3001\u540c\u4e00\u69d8\u5f0f\u3067FDA\u306b\u9001\u4ed8\u3059\u308b\u3002(\u305d\u306e\u6642\u3001new\u3000file\u7b49\u306e\u8a18\u8ff0\u306f\u3057\u306a\u3044)<\/li>\n
      4. FDA\u306e\u53d7\u9818\u7a93\u53e3\u3000\u201cFDA\u3000ESG\u201d\u3000\uff1b\u5b89\u5168\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b<\/li>\n
      5. FDA\u306eeCTD\u306e\u53d7\u9818\u65e5\uff1bFDA\u306bfile\u304c\u5230\u7740\u3057\u305f\u65e5\u3067\u306a\u304f\u3001\u69d8\u5f0f\u7b49\u306e\u96fb\u5b50\u60c5\u5831\u306e\u5185\u5bb9\u3092\u78ba\u8a8d\u3057\u305f\u65e5\u304c\u3001FDA\u53d7\u9818\u65e5\u3068\u306a\u308b\u3002<\/li>\n<\/ol>\n

         <\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-6253","news","type-news","status-publish","hentry","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/6253","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=6253"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=6253"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}