{"id":9166,"date":"2021-05-24T06:13:51","date_gmt":"2021-05-24T06:13:51","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9166"},"modified":"2023-04-18T11:31:52","modified_gmt":"2023-04-18T11:31:52","slug":"what-is-regulatory-dossier-and-what-does-it-contain","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/","title":{"rendered":"What Is Regulatory Dossier and What Does It Contain?"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f70b8cc8e42\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f70b8cc8e42\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#Introduction_What_is_a_regulatory_dossier\" title=\"\u306f\u3058\u3081\u306b\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30c9\u30b7\u30a8\u3068\u306f\uff1f\">\u306f\u3058\u3081\u306b\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30c9\u30b7\u30a8\u3068\u306f\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#CTD_Common_Technical_Document\" title=\"CTD\uff08\u30b3\u30e2\u30f3\u30fb\u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\">CTD\uff08\u30b3\u30e2\u30f3\u30fb\u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#CTD-Module_1\" title=\"CTD-Module 1\">CTD-Module 1<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#Specifications_for_US_Module_1_Administrative_Information_and_Prescribing_Information\" title=\"US\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u4ed5\u69d8\uff1a\u7ba1\u7406\u60c5\u5831\u3068\u51e6\u65b9\u60c5\u5831\">US\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u4ed5\u69d8\uff1a\u7ba1\u7406\u60c5\u5831\u3068\u51e6\u65b9\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#Specifications_for_European_Union_EU_Module_1_Administrative_Information_and_Prescribing_Information\" title=\"\u6b27\u5dde\u9023\u5408(EU)\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u4ed5\u69d8\uff1a\u7ba1\u7406\u60c5\u5831\u3068\u51e6\u65b9\u7b8b\u60c5\u5831\">\u6b27\u5dde\u9023\u5408(EU)\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u4ed5\u69d8\uff1a\u7ba1\u7406\u60c5\u5831\u3068\u51e6\u65b9\u7b8b\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#CTD-Module_2\" title=\"CTD-Module 2\">CTD-Module 2<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#CTD-Module_3\" title=\"CTD-Module 3\">CTD-Module 3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#CTD-Module_4\" title=\"CTD-Module 4\">CTD-Module 4<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#CTD-Module_5\" title=\"CTD-Module 5\">CTD-Module 5<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/#Additional_References\" title=\"\u305d\u306e\u4ed6\u306e\u53c2\u8003\u8cc7\u6599\">\u305d\u306e\u4ed6\u306e\u53c2\u8003\u8cc7\u6599<\/a><\/li><\/ul><\/nav><\/div>\n<p>Nare Simonyan, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs\" target=\"_blank\" rel=\"noopener\">freelance regulatory affairs specialist<\/a> \u306eKolabtree\u3067\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u66f8\u985e\u3068\u305d\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306b\u95a2\u3059\u308b\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Introduction_What_is_a_regulatory_dossier\"><\/span><strong>\u306f\u3058\u3081\u306b\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30c9\u30b7\u30a8\u3068\u306f\uff1f<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30c9\u30b7\u30a8\u3068\u306f\u3001\u65b0\u3057\u304f\u958b\u767a\u3055\u308c\u305f\u533b\u85ac\u54c1\u3084\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u5fc5\u8981\u306a\u60c5\u5831\u3092\u542b\u3080\u6587\u66f8\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u3067\u3042\u308a\u3001EU\u304a\u3088\u3073\u7c73\u56fd\u306e\u898f\u5236\u5f53\u5c40\u304c\u8ca9\u58f2\u627f\u8a8d\u3092\u4e0e\u3048\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u66f8\u985e\u306b\u542b\u307e\u308c\u308b\u4e3b\u306a\u60c5\u5831\u306f\u3001\u7ba1\u7406\u60c5\u5831\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u3067\u3042\u308a\u3001CTD\uff08Common Technical Document\uff09\u5f62\u5f0f\u3067\u7d19\u3068\u96fb\u5b50\u306e\u4e21\u65b9\u3067\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7d19\u5a92\u4f53\u3067\u63d0\u51fa\u3055\u308c\u305f\u60c5\u5831\u306f\u81a8\u5927\u3067\u3042\u3063\u305f\u305f\u3081\u3001\u73fe\u5728\u3001\u5404\u6a5f\u95a2\u306feCTD\u5f62\u5f0f\u3067\u306e\u7533\u8acb\u3092\u5968\u52b1\u3057\u3066\u3044\u308b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"CTD_Common_Technical_Document\"><\/span><a name=\"_Toc71877842\"><\/a><strong>CTD\uff08\u30b3\u30e2\u30f3\u30fb\u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>2003\u5e74\u3001ICH(International Council of Harmonization)\u306e\u30e1\u30f3\u30d0\u30fc\u306f\u3001\u3059\u3079\u3066\u306e\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u3001\u304b\u3064\u3066CTD\u3068\u547c\u3070\u308c\u3066\u3044\u305f\u5171\u901a\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306b\u307e\u3068\u3081\u308b\u3053\u3068\u306b\u5408\u610f\u3057\u307e\u3057\u305f\u3002CTD\u306f\u3001NDA(New Drug Application)\u3001MAA(Marketing Authorization Application)\u3001\u304a\u3088\u3073\u30b0\u30ed\u30fc\u30d0\u30eb\u30e1\u30c7\u30a3\u30b7\u30ca\u30eb\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u30e2\u30b8\u30e5\u30fc\u30eb1\u304b\u30895\u307e\u3067\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\/\u69cb\u9020\u3067\u3042\u308b\u3002\u30e2\u30b8\u30e5\u30fc\u30eb1\u306b\u306f\u3001\u56fd\u3054\u3068\u306b\u7570\u306a\u308b\u884c\u653f\u4e0a\u306e\u5730\u57df\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u30e2\u30b8\u30e5\u30fc\u30eb2\u30013\u30014\u30015\u306f\u3059\u3079\u3066\u306e\u5730\u57df\u3067\u5171\u901a\u3067\u3059\u3002CTD\u306e\u69cb\u9020\u306f\u3001\u6cbb\u9a13\u7533\u8acb\u3068\u5546\u696d\u7533\u8acb\u306e\u4e21\u65b9\uff08IND\uff08\u6cbb\u9a13\u85ac\uff09\u3068NDA\uff08\u7c73\u56fd\uff09\u3001IMPD\uff08\u6cbb\u9a13\u85ac\uff09\u3068MAA\uff08EU\uff09\u3001\u304a\u3088\u3073\u30b0\u30ed\u30fc\u30d0\u30eb\u7533\u8acb\uff09\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>CTD\u306f\u4e3b\u306bNDA\u3001BLA\uff08Biologics License Application\uff09\u3001MAA\u3001NDS\uff08New Drug Substance\uff09\u3001JNDA\uff08Japanese New Drug Application\uff09\u306a\u3069\u306e\u65b0\u898f\u8ca9\u58f2\u7533\u8acb\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002FDA\u3084EMA\u304b\u3089\u306e\u8ffd\u52a0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308a\u3001CTD\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u7533\u8acb-IMPD\u3084IND\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u7533\u8acb\u306b\u5fc5\u8981\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u3059\u3079\u3066\u306e\u30c9\u30e9\u30c3\u30b0\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08DMF\uff09\u304a\u3088\u3073\u6d3b\u6027\u7269\u8cea\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08ASMF\uff09\u306f\u3001CTD\u306e\u69cb\u9020\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u85ac\u4e8b\u7533\u8acb\u66f8\u985e\u306e\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u306f\u3001CFR\uff08Code of Federal Regulations\uff09\uff08\u7c73\u56fd\u306e\u6cd5\u5f8b\uff09\u304a\u3088\u3073Directives\uff08EU\u306e\u6cd5\u5f8b\uff09\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-9169\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/05\/CTD-structure.png\" alt=\"\" width=\"577\" height=\"388\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/05\/CTD-structure.png 577w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/05\/CTD-structure-300x202.png 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/05\/CTD-structure-16x12.png 16w\" sizes=\"(max-width: 577px) 100vw, 577px\" \/><\/p>\n<p><strong><em>\u56f31.CTD\u306e\u69cb\u9020<\/em><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"CTD-Module_1\"><\/span><a name=\"_Toc71877843\"><\/a><strong>CTD-Module 1<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h2><span class=\"ez-toc-section\" id=\"Specifications_for_US_Module_1_Administrative_Information_and_Prescribing_Information\"><\/span><a name=\"_Toc71877844\"><\/a><strong>US\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u4ed5\u69d8\uff1a\u7ba1\u7406\u60c5\u5831\u3068\u51e6\u65b9\u60c5\u5831<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>e-CTD\u30e2\u30b8\u30e5\u30fc\u30eb1\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u306f\u3001\u7ba1\u7406\u7528\u304a\u3088\u3073\u30e9\u30d9\u30eb\u7528\u306e\u6587\u66f8\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u7533\u8acb\u66f8\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u63d0\u51fa\u7269\u306f\u3001\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u6587\u66f8\u306b\u5bfe\u3057\u3066\u540c\u3058\u7d44\u7e54\u69cb\u9020\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u30e2\u30b8\u30e5\u30fc\u30eb1\u3067\u63d0\u4f9b\u3055\u308c\u308b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u4ed5\u69d8\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n<p><strong>\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\uff08\u30bb\u30af\u30b7\u30e7\u30f31.2<\/strong><\/p>\n<p>\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u306b\u306f\u3001\u5be9\u67fb\u904e\u7a0b\u3067\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u5f79\u7acb\u3064\u9069\u5207\u306a\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u306b\u306f\u4ee5\u4e0b\u306e\u60c5\u5831\u3092\u542b\u3081\u308b\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u3066\u3044\u307e\u3059\uff08\u8a73\u7d30\u306f \"<a href=\"https:\/\/www.fda.gov\/media\/135573\/download\">Electronic Common Technical Document (eCTD) v4.0 \u6280\u8853\u7684\u9069\u5408\u6027\u30ac\u30a4\u30c9<\/a>\")<\/p>\n<ul>\n<li>\u9069\u5207\u306a\u898f\u5236\u60c5\u5831\u3001\u304a\u3088\u3073\u63d0\u51fa\u3055\u308c\u305f\u60c5\u5831\u3078\u306e\u5e0c\u671b\u3059\u308b\u30cf\u30a4\u30d1\u30fc\u30ea\u30f3\u30af\u3092\u542b\u3080\u3001\u63d0\u51fa\u7269\u306e\u898f\u5236\u306b\u95a2\u3059\u308b\u8a18\u8ff0<\/li>\n<li>\u63d0\u51fa\u7269\u306e\u304a\u304a\u3088\u305d\u306e\u30b5\u30a4\u30ba\uff08\u4f8b\uff1a2\u30ae\u30ac\u30d0\u30a4\u30c8\uff09\u3092\u542b\u3080\u3001\u63d0\u51fa\u7269\u306e\u6280\u8853\u7684\u306a\u8aac\u660e<\/li>\n<li>\u30d5\u30a1\u30a4\u30eb\u306e\u30a6\u30a4\u30eb\u30b9\u30c1\u30a7\u30c3\u30af\u306b\u4f7f\u7528\u3057\u305f\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08\u540d\u79f0\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u3001\u4f1a\u793e\u540d\uff09\u306e\u8aac\u660e\u3068\u3068\u3082\u306b\u3001\u63d0\u51fa\u7269\u304c\u30a6\u30a4\u30eb\u30b9\u306b\u611f\u67d3\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u8868\u660e\u3059\u308b\u3053\u3068<\/li>\n<li>\u63d0\u51fa\u7269\u306b\u95a2\u3059\u308b\u898f\u5236\u4e0a\u304a\u3088\u3073\u6280\u8853\u4e0a\u306e\u9023\u7d61\u5148\uff08\u96fb\u5b50\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9\u3092\u542b\u3080\uff09\u3002<\/li>\n<\/ul>\n<p><strong>\u30d5\u30a3\u30fc\u30eb\u30c9\u30b3\u30d4\u30fc\u8a8d\u8a3c\uff081.3\u9805<\/strong><\/p>\n<p>Field Copy Certification\u306f\u3001\u5e02\u8ca9\u7533\u8acb\u7528\u306eeCTD\u306b\u542b\u307e\u308c\u308b\u3079\u304d\u3082\u306e\u3067\u3059\u3002eCTD \u3092 FDA \u306b\u63d0\u51fa\u3059\u308b\u3053\u3068\u3092\u901a\u77e5\u3059\u308b\u624b\u7d19\u3092\u5730\u533a\u4e8b\u52d9\u6240\u306b\u9001\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u624b\u7d19\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u85ac\u5264\u304a\u3088\u3073\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u756a\u53f7<\/li>\n<li>FDA\u30bb\u30f3\u30bf\u30fc\uff06\u30c7\u30a3\u30d3\u30b8\u30e7\u30f3<\/li>\n<li>\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306feCTD\u5f62\u5f0f\u3067\u3059\u3002<\/li>\n<\/ul>\n<p><strong>\u53c2\u8003\u6587\u732e\uff081.4\u9805<\/strong><\/p>\n<p>\u53c2\u8003\u8cc7\u6599\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u30b5\u30d6\u30bb\u30af\u30b7\u30e7\u30f3\u304c\u542b\u307e\u308c\u307e\u3059\uff08\u8ffd\u52a0\u30b3\u30f3\u30c6\u30f3\u30c4\u3082\u5fc5\u8981\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\uff09\u3002<\/p>\n<ul>\n<li>\u8a31\u53ef\u8a3c\uff08LOA\uff09\u306e\u767a\u884c<\/li>\n<li>\u904e\u53bb\u306b\u63d0\u51fa\u3057\u305feCTD\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u4ee5\u5916\u306e\u60c5\u5831\u306e\u76f8\u4e92\u53c2\u7167\u306b\u3064\u3044\u3066<\/li>\n<\/ul>\n<p><strong>\u60c5\u5831\u306e\u4fee\u6b63\uff081.11\u9805<\/strong><\/p>\n<p>\u3053\u308c\u306f\u3001\u63d0\u51fa\u3055\u308c\u308b\u60c5\u5831\u304c\u30e2\u30b8\u30e5\u30fc\u30eb2\u30013\u30014\u30015\u306e\u3069\u306e\u898b\u51fa\u3057\u306b\u3082\u5f53\u3066\u306f\u307e\u3089\u306a\u3044\u5834\u5408\u306b\u3001\u60c5\u5831\u8981\u6c42\uff08IR\uff09\u306b\u5bfe\u3059\u308b\u56de\u7b54\u3092\u63d0\u51fa\u3059\u308b\u969b\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002IR\u306e\u56de\u7b54\u304c\u30e2\u30b8\u30e5\u30fc\u30eb2\uff5e5\u3067\u63d0\u51fa\u3055\u308c\u305f\u6587\u66f8\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5834\u5408\u306f\u3001\u65b0\u898f\u307e\u305f\u306f\u5dee\u3057\u66ff\u3048\u306e\u6587\u66f8\u3092\u30e2\u30b8\u30e5\u30fc\u30eb2\uff5e5\u306e\u9069\u5207\u306a\u5834\u6240\u306b\u63d0\u51fa\u3057\u3001\u30bb\u30af\u30b7\u30e7\u30f31.11\u306e\u6587\u66f8\u3067\u53c2\u7167\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30fb\u30a2\u30cb\u30e5\u30a2\u30eb\u30ec\u30dd\u30fc\u30c8\uff081.13\u9805<\/strong><\/p>\n<p>\u30dd\u30b9\u30c8\u30fb\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30fb\u30ea\u30af\u30a8\u30b9\u30c8\/\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u30fb\u30d5\u30a1\u30a4\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5404\u7814\u7a76\u307e\u305f\u306f\u8a66\u9a13\u306b\u3064\u3044\u3066\u306f\u3001\u30d6\u30c3\u30af\u30de\u30fc\u30af\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u30e9\u30d9\u30ea\u30f3\u30b0\uff081.14\u9805 <\/strong><\/p>\n<p>1.14\u9805\u3067\u306f\u3001\u7279\u5b9a\u306e\u30e9\u30d9\u30ea\u30f3\u30b0\u6587\u66f8\u3092\u63d0\u4f9b\u3059\u308b\u65b9\u6cd5\u3092\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u30022253\u7533\u8acb*\u306e\u305f\u3081\u306e\u30c9\u30e9\u30d5\u30c8\u8868\u793a\u3001\u6700\u7d42\u8868\u793a\u3001\u4e0a\u5834\u533b\u85ac\u54c1\u8868\u793a\u3001\u6cbb\u9a13\u85ac\u8868\u793a\u3001\u5916\u56fd\u8a9e\u8868\u793a\u3001\u88fd\u54c1\u8868\u793a\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u63d0\u4f9b\u3055\u308c\u308b\u60c5\u5831\u306b\u306f\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u306e\u6b74\u53f2\u3001\u5185\u5bb9\u3001\u30b5\u30f3\u30d7\u30eb\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><em>Form FDA 2253*\u3067\u3059\u3002 <\/em><a href=\"https:\/\/www.fda.gov\/media\/128163\/download\"><em>\u4eba\u4f53\u7528\u533b\u85ac\u54c1\u304a\u3088\u3073\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u5e83\u544a\u304a\u3088\u3073\u8ca9\u58f2\u4fc3\u9032\u7528\u30e9\u30d9\u30eb\u306e\u9001\u4ed8\u306b\u3064\u3044\u3066<\/em><\/a><\/p>\n<p><strong>\u5e83\u544a\u304a\u3088\u3073\u8ca9\u4fc3\u7528\u30e9\u30d9\u30eb\u7d20\u6750\uff08\u30bb\u30af\u30b7\u30e7\u30f31.15 <\/strong><\/p>\n<p>\u7c73\u56fd\u3067\u306f\u3001\u5e83\u544a\u3084\u8ca9\u4fc3\u7528\u306e\u30e9\u30d9\u30ea\u30f3\u30b0\u8cc7\u6599\u304c\u5236\u9650\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001FDA\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8981\u4ef6\u3092\u53cd\u6620\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.fda.gov\/media\/128163\/download\"><em>\u96fb\u5b50\u304a\u3088\u3073\u975e\u96fb\u5b50\u5f62\u5f0f\u3067\u306e\u898f\u5236\u5f53\u5c40\u3078\u306e\u63d0\u51fa\u7269\u306e\u63d0\u4f9b-\u30d2\u30c8\u7528\u51e6\u65b9\u85ac\u306e\u8ca9\u58f2\u4fc3\u9032\u7528\u30e9\u30d9\u30eb\u304a\u3088\u3073\u5e83\u544a\u8cc7\u6599<\/em><\/a>.<\/p>\n<p>\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u5f8c\u306e\u5831\u544a\u7fa9\u52d9\u306e\u4e00\u74b0\u3068\u3057\u3066\u63d0\u51fa\u3055\u308c\u308b\u8ca9\u4fc3\u8cc7\u6599\u306b\u3064\u3044\u3066\u306f\u3001\u53c2\u8003\u6587\u732e\u3084\u30e9\u30d9\u30eb\u3078\u306e\u30cf\u30a4\u30d1\u30fc\u30c6\u30ad\u30b9\u30c8\u30ea\u30f3\u30af\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u63d0\u6848\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u53c2\u8003\u6587\u732e\u306f\u5be9\u67fb\u306e\u52b9\u7387\u3092\u9ad8\u3081\u307e\u3059\u3002<\/p>\n<p><strong>\u30ea\u30b9\u30af\u8a55\u4fa1\u304a\u3088\u3073\u7de9\u548c\u6226\u7565\uff08REMS\uff09\uff08\u30bb\u30af\u30b7\u30e7\u30f31.16<\/strong><\/p>\n<p>REMS\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306f\u3001\u65b0\u3057\u3044REMS\u307e\u305f\u306f\u627f\u8a8d\u3055\u308c\u305fREMS\u306e\u4fee\u6b63\uff08\u30e1\u30b8\u30e3\u30fc\u304a\u3088\u3073\u30de\u30a4\u30ca\u30fc\uff09\u3092\u63d0\u6848\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u9069\u5207\u306aFDA\u30d5\u30a9\u30fc\u30e0\u63d0\u51fa\u30bf\u30a4\u30d7\u306eREMS\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u9078\u629e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002REMS\u8a55\u4fa1\u3001REMS\u6539\u8a02\u3001\u304a\u3088\u3073REMS\u5bfe\u5fdc\u306f\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3067\u306f\u306a\u3044\u3002\u3053\u306e\u5834\u5408 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">\u6295\u7a3f\u30bf\u30a4\u30d7<\/a> \u306f\u3001FDA\u30d5\u30a9\u30fc\u30e0\u3092\u8a18\u5165\u3059\u308b\u969b\u306b\u300c\u305d\u306e\u4ed6\u300d\u3092\u9078\u629e\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Specifications_for_European_Union_EU_Module_1_Administrative_Information_and_Prescribing_Information\"><\/span><a name=\"_Toc71877845\"><\/a><strong>\u6b27\u5dde\u9023\u5408(EU)\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u4ed5\u69d8\uff1a\u7ba1\u7406\u60c5\u5831\u3068\u51e6\u65b9\u7b8b\u60c5\u5831<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\uff08Section 1.0<\/strong><\/p>\n<p>\u5404\u7533\u8acb\u66f8\u306b\u306f\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u3092\u6dfb\u4ed8\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ab\u30d0\u30fc\u30ec\u30bf\u30fc\u306e\u4ed8\u9332\u3068\u3057\u3066\u300c\u5be9\u67fb\u54e1\u3078\u306e\u6ce8\u610f\u4e8b\u9805\u300d\u6587\u66f8\u3092\u6dfb\u4ed8\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30ca\u30d3\u30b2\u30fc\u30b7\u30e7\u30f3\u3092\u5bb9\u6613\u306b\u3059\u308b\u305f\u3081\u306b\u3055\u3089\u306a\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u306b\u5099\u3048\u3066\u306e\u3053\u3068\u3067\u3059\u3002<\/p>\n<p><strong>\u7dcf\u5408\u76ee\u6b21\uff08\u30bb\u30af\u30b7\u30e7\u30f31.1<\/strong><\/p>\n<p>\u7533\u8acb\u66f8\u306e\u7a2e\u985e\u3054\u3068\u306b\u5305\u62ec\u7684\u306a\u76ee\u6b21\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u76ee\u6b21\u306b\u306f\u3001\u5f53\u8a72\u7533\u8acb\u66f8\u306e\u4e00\u90e8\u3068\u3057\u3066\u63d0\u51fa\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u30bb\u30af\u30b7\u30e7\u30f3\u3092\u542b\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u65b0\u898f\u7533\u8acb\u306e\u5834\u5408\u306b\u306f\u3001\u3059\u3079\u3066\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3092\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u5fdc\u52df\u7528\u7d19\uff081.2\u9805<\/strong><\/p>\n<p>\u63d0\u51fa\u7269\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066\u3001\u95a2\u9023\u3059\u308b\u7533\u8acb\u66f8\u3092\u898f\u5236\u5f53\u5c40\u306e\u66f8\u985e\u306b\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u5404\u7a2e\u7533\u8acb\u66f8\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8 \/ \uff08\u82f1\u8a9e\uff09\u3067\u3054\u89a7\u3044\u305f\u3060\u3051\u307e\u3059\u3002<\/p>\n<p>DG\u30a8\u30f3\u30bf\u30fc\u30d7\u30e9\u30a4\u30ba\u3002<\/p>\n<ul>\n<li>\u65b0\u3057\u3044\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u62e1\u5f35\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3 <a href=\"http:\/\/ec.europa.eu\/enterprise\/pharmaceuticals\/eudralex\/homev2.htm#2b\">http:\/\/ec.europa.eu\/enterprise\/pharmaceuticals\/eudralex\/homev2.htm#2b<\/a><\/li>\n<li>\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/li>\n<\/ul>\n<p><a href=\"http:\/\/ec.europa.eu\/enterprise\/pharmaceuticals\/eudralex\/homev2.htm#2c\">http:\/\/ec.europa.eu\/enterprise\/pharmaceuticals\/eudralex\/homev2.htm#2c<\/a><\/p>\n<ul>\n<li>\u66f4\u65b0\u7533\u8acb<\/li>\n<\/ul>\n<p><a href=\"http:\/\/ec.europa.eu\/enterprise\/pharmaceuticals\/eudralex\/homev2.htm#2c\">http:\/\/ec.europa.eu\/enterprise\/pharmaceuticals\/eudralex\/homev2.htm#2c<\/a><\/p>\n<p><strong>\u88fd\u54c1\u60c5\u5831\uff081.3\u9805<\/strong><\/p>\n<p>\u30bb\u30af\u30b7\u30e7\u30f31.3\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u88fd\u54c1\u7279\u6027\u306e\u6982\u8981\uff08SPC\uff09\u3001\u30e9\u30d9\u30eb\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u30fb\u30ea\u30fc\u30d5\u30ec\u30c3\u30c8\uff08PIL <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.3.1)<\/strong><\/li>\n<li>\u30e2\u30c3\u30af\u30a2\u30c3\u30d7 <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.3.2)<\/strong><\/li>\n<li>\u6a19\u672c <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.3.3)<\/strong><\/li>\n<li>\u5bfe\u8c61\u3068\u306a\u308b\u60a3\u8005\u69d8\u30b0\u30eb\u30fc\u30d7\u3068\u306e\u5354\u8b70 <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.3.4)<\/strong><\/li>\n<li>\u30e1\u30f3\u30d0\u30fc\u56fd\u3067\u65e2\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u60c5\u5831 <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.3.5) <\/strong>(\u8a72\u5f53\u3059\u308b\u5834\u5408)<\/li>\n<li>\u70b9\u5b57 <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.3.6)<\/strong><\/li>\n<\/ul>\n<p><strong>\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u306b\u95a2\u3059\u308b\u60c5\u5831\uff081.4\u9805<\/strong><\/p>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u306f\u3001\u6307\u4ee4 2001\/83 \/ EC \u306e\u7b2c 12 \u6761\u306b\u5f93\u3063\u3066\u30e2\u30b8\u30e5\u30fc\u30eb 3\u30014 \u53ca\u3073 5 \u3092\u69cb\u6210\u3059\u308b\u6587\u66f8\u53ca\u3073\u60c5\u5831\u306e\u8a73 \u7d30\u306a\u30ec\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u5c02\u9580\u5bb6\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306e\u8ffd\u52a0\u90e8\u5206\u306b\u306f\u3001\u66f8\u985e\u306e\u7570\u306a\u308b\u79d1\u5b66\u7684\u90e8\u5206\u306e\u305f\u3081\u306e\u7f72\u540d\u5165\u308a\u5c02\u9580\u5bb6\u30ec\u30dd\u30fc\u30c8\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u7f72\u540d\u5165\u308a\u5c02\u9580\u5bb6\u5831\u544a\u66f8\u306e\u8981\u4ef6\u3092\u4ee5\u4e0b\u306b\u793a\u3059\u3002<\/p>\n<ul>\n<li>\u30e2\u30b8\u30e5\u30fc\u30eb2\u306e\u300c\u30af\u30aa\u30ea\u30c6\u30a3\u30fc\u30fb\u30aa\u30fc\u30d0\u30fc\u30aa\u30fc\u30eb\u30fb\u30b5\u30de\u30ea\u30fc\u300d\u3001\u300c\u30ce\u30f3\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30aa\u30fc\u30d0\u30fc\u30aa\u30fc\u30eb\uff0f\u30b5\u30de\u30ea\u30fc\u300d\u3001\u300c\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30aa\u30fc\u30d0\u30fc\u30aa\u30fc\u30eb\uff0f\u30b5\u30de\u30ea\u30fc\u300d\u3002<\/li>\n<li>\u30e2\u30b8\u30e5\u30fc\u30eb1.4\u306e\u5c02\u9580\u5bb6\u304c\u7f72\u540d\u3057\u305f\u5ba3\u8a00\u66f8\u3002<\/li>\n<li>\u30e2\u30b8\u30e5\u30fc\u30eb1.4\u306e\u6559\u80b2\u7684\u80cc\u666f\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u8077\u696d\u7d4c\u9a13\u306b\u3064\u3044\u3066\u306e\u7c21\u5358\u306a\u60c5\u5831\u3002<\/li>\n<\/ul>\n<p>\u627f\u8a8d\u5f8c\u306e\u7533\u8acb\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6\u306e\u5ba3\u8a00\u66f8\u3092\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p>\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u8005\u304c\u3001\u305d\u306e\u5ba3\u8a00\u3092\u3044\u304b\u306a\u308b\u3082\u306e\u3068\u3082\u533a\u5225\u3057\u305f\u3044\u5834\u5408\u306b\u306f<\/p>\n<p>\u904e\u53bb\u306e\u7533\u544a\u66f8\u3001\u53c2\u7167\u52a0\u76df\u56fd\/EMEA\u306e\u95a2\u9023\u624b\u7d9a\u304d\u756a\u53f7<\/p>\n<p>\u306f\u30c8\u30c3\u30d7\u306b\u542b\u307e\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u4ee5\u4e0b\u3001\u300c\u5c02\u9580\u5bb6\u306b\u95a2\u3059\u308b\u60c5\u5831\u300d\u306e\u30b5\u30d6\u30bb\u30af\u30b7\u30e7\u30f3\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u54c1\u8cea (1.4.1\u9805)<\/strong><\/li>\n<li><strong>\u30ce\u30f3\u30af\u30ea\u30cb\u30ab\u30eb\uff081.4.2<\/strong><\/li>\n<li><strong>\u81e8\u5e8a (\u30bb\u30af\u30b7\u30e7\u30f31.4.3)<\/strong><\/li>\n<\/ul>\n<p>\u8a73\u7d30\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u7b2c 12 \u6761\u3092\u53c2\u7167\u3057\u3001\u6307\u4ee4 2001\/83\/EC \u306e\u4ed8\u5c5e\u66f8 I\u3001\u30d1\u30fc\u30c8 I 1.4 \u306b\u5f93\u3063\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><strong>\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u305f\u56fa\u6709\u306e\u8981\u4ef6\uff081.5\u9805<\/strong><\/p>\n<p><strong>\u66f8\u8a8c\u7684\u5fdc\u7528\u306e\u305f\u3081\u306e\u60c5\u5831\uff081.5.1\u9805<\/strong><\/p>\n<p>\u6307\u4ee42001\/83\/EC\u306e\u7b2c10a\u6761\u306b\u57fa\u3065\u304d\u3001\u7533\u8acb\u8005\u306f\u3001\u6307\u4ee42001\/83\/EC\u306e\u9644\u5c5e\u66f8I\u306e\u30d1\u30fc\u30c8II.1\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u533b\u85ac\u54c1\u306e\u69cb\u6210\u8981\u7d20\uff08\u8907\u6570\u53ef\uff09\u304c\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u8a31\u5bb9\u30ec\u30d9\u30eb\u3092\u8003\u616e\u3057\u305f\u4e0a\u3067\u3001\u78ba\u7acb\u3055\u308c\u305f\u7528\u9014\u3092\u6709\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u305f\u6839\u62e0\u3068\u8a3c\u62e0\u3092\u8981\u7d04\u3057\u305f\u7c21\u6f54\u306a\u6587\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n<p><strong>\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u3001\u300c\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u300d\u307e\u305f\u306f\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306e\u7533\u8acb\u306b\u95a2\u3059\u308b\u60c5\u5831\uff081.5.2\u9805<\/strong><\/p>\n<p>\u6307\u4ee42001\/83\/EC\u306e\u7b2c10\u6761(1)\u3001\u7b2c10\u6761(3)\u307e\u305f\u306f\u7b2c10\u6761(4)\u306b\u57fa\u3065\u304d\u3001\u7533\u8acb\u8005\u306f\u3053\u3053\u3067\u3001\u7533\u8acb\u304c\u63d0\u51fa\u3055\u308c\u308b\u533b\u85ac\u54c1\u306e\u7a2e\u985e\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u6839\u62e0\u3068\u8a3c\u62e0\u3092\u8981\u7d04\u3057\u305f\u7c21\u6f54\u306a\u6587\u66f8\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u533b\u85ac\u54c1\u306b\u306f\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u3001\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u88fd\u54c1\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>(\u62e1\u5f35)\u30c7\u30fc\u30bf\/\u5e02\u5834\u306e\u72ec\u5360\u6a29(1.5.3\u9805)<\/strong><\/p>\n<p>1.5.3\u9805\u306f\u3001MA\u4fdd\u6709\u8005\uff0f\u7533\u8acb\u8005\u304c\u3001\u65b0\u3057\u3044\u9069\u5fdc\u75c7\u3084\u5206\u985e\u306e\u5909\u66f4\u3092\u7533\u8acb\u3059\u308b\u969b\u306b\u3001\uff08\u8ffd\u52a0\u306e\uff09\u30c7\u30fc\u30bf\uff0f\u5e02\u5834\u72ec\u5360\u6a29\u3092\u4e3b\u5f35\u3057\u305f\u3044\u5834\u5408\u306b\u5fc5\u8981\u3067\u3059\u3002\u3053\u306e\u5834\u5408\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u6cd5\u5f8b\u306e\u898f\u5b9a\u3068\u8981\u4ef6\u3092\u8003\u616e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p><strong>\u4f8b\u5916\u7684\u72b6\u6cc1\uff081.5.4\u9805<\/strong><\/p>\n<p>\u6307\u4ee42001\/83\/EC\u306e\u7b2c22\u6761\u53ca\u3073\u898f\u5247(EC)No726\/2004\u306e\u7b2c14\u6761(7)\u306b\u3088\u308c\u3070\u3001\u4f8b\u5916\u7684\u306a\u72b6\u6cc1\u306e\u5834\u5408\u306b\u306f\u3001\u7279\u306b\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u305d\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u3042\u3089\u3086\u308b\u4e8b\u6545\u306e\u7ba1\u8f44\u5f53\u5c40\u3078\u306e\u901a\u77e5\u306b\u95a2\u3059\u308b\u7279\u5b9a\u306e\u624b\u7d9a\u304d\u304c\u7533\u8acb\u8005\u306b\u3088\u3063\u3066\u5c0e\u5165\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306b\u306f\u3001\u8a8d\u53ef\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u5ba2\u89b3\u7684\u3067\u691c\u8a3c\u53ef\u80fd\u306a\u4f8b\u5916\u306e\u5834\u5408\u306b\u306e\u307f\u3001\u8a8d\u53ef\u3092\u4e0e\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/p>\n<p><strong>\u6761\u4ef6\u4ed8\u8ca9\u58f2\u8a31\u53ef\uff081.5.5\u9805<\/strong><\/p>\n<p>\u672c\u9805\u306f\u3001\u96c6\u4e2d\u7ba1\u7406\u578b\u306e\u624b\u7d9a\u304d\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306e\u53c2\u8003\u6587\u732e\u306f\u3001Regulation (EC) No 726\/2004\u306eArticle 14(7)\u3068\"<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-scientific-application-practical-arrangements-necessary-implement-commission-regulation-ec\/2006-conditional-marketing-authorisation-medicinal-products-human-use-falling_en.pdf\">\u6761\u4ef6\u4ed8\u8ca9\u58f2\u8a31\u53ef\u306e\u79d1\u5b66\u7684\u9069\u7528\u3068\u5b9f\u52d9\u4e0a\u306e\u53d6\u308a\u6c7a\u3081\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>\".<\/p>\n<p><strong>\u74b0\u5883\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\uff081.6\u9805<\/strong><\/p>\n<p>\u6307\u4ee42001\/83\/EC\u306e\u7b2c8\u6761(ca)\u53ca\u3073(g)\u306b\u5f93\u3044\u3001\u533b\u85ac\u54c1\u306e\u74b0\u5883\u306b\u5bfe\u3059\u308b\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u306f\u3001\u7533\u8acb\u8005\u304c\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u306e\u627f\u8a8d\u7533\u8acb\u4e2d\u306b\u8003\u616e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u306e\u6307\u4ee4\u306e\u8981\u6c42\u4e8b\u9805\u306f\u3001\u533b\u85ac\u54c1\u306e\u4f7f\u7528\u3001\u4fdd\u7ba1\u3001\u5ec3\u68c4\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u88fd\u54c1\u306e\u5408\u6210\u3084\u88fd\u9020\u306b\u306f\u9069\u7528\u3055\u308c\u307e\u305b\u3093\u3002\u907a\u4f1d\u5b50\u7d44\u307f\u63db\u3048\u4f5c\u7269\u3092\u542b\u307e\u306a\u3044\u533b\u85ac\u54c1\uff08Non-GMO Section 1.6.1\uff09\u304a\u3088\u3073\u907a\u4f1d\u5b50\u7d44\u307f\u63db\u3048\u4f5c\u7269\u3092\u542b\u3080\u533b\u85ac\u54c1\uff08GMO 1.6.2\uff09\u306e\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u306f\u3001\u898f\u5236\u5f53\u5c40\u7528\u66f8\u985e\u306e\u30e2\u30b8\u30e5\u30fc\u30eb1\u306b\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u306e\u8868\u793a\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf\">\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u74b0\u5883\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>\"<\/p>\n<p><strong>\u30aa\u30fc\u30d5\u30a1\u30f3\u30de\u30fc\u30b1\u30c3\u30c8\u306e\u72ec\u5360\u6a29\u306b\u95a2\u9023\u3059\u308b\u60c5\u5831\uff08\u7b2c1.7\u9805<\/strong><\/p>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u30aa\u30fc\u30d5\u30a1\u30f3\u30fb\u30e1\u30c7\u30a3\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u306e\u307f\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u8a73\u7d30\u3084\u624b\u7d9a\u304d\u306b\u3064\u3044\u3066\u306e\u5fc5\u8981\u306a\u60c5\u5831\u306f\u3001\"<a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/orphanmp\/doc\/c_2008_4077_en.pdf\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u3001Regulation (EC) No 141\/2000\u306eArticle 8\u306e\u9069\u7528\u306b\u95a2\u3059\u308b\u5074\u9762\u306b\u3064\u3044\u3066\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u4f5c\u6210\u3057\u305f\u3002\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u304a\u3088\u3073\u305d\u306e\u5909\u66f4\u3092\u8a55\u4fa1\u3059\u308b\u969b\u306e\u3001\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u306e\u985e\u4f3c\u6027\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u81e8\u5e8a\u7684\u512a\u4f4d\u6027\u306e\u8a55\u4fa1\u3002<\/a>\"<\/p>\n<p>1.7.1\u9805\u306e\u300c\u985e\u4f3c\u6027\u300d\u30681.7.2\u9805\u306e\u300c\u5e02\u5834\u72ec\u5360\u6027\u300d\u304c\u9069\u7528\u3055\u308c\u308b\u5834\u5408\u3001\u7533\u8acb\u3055\u308c\u308b\u4e88\u5b9a\u306e\u6cbb\u7642\u9069\u5fdc\u75c7\u3092\u30ab\u30d0\u30fc\u3059\u308b\u6761\u4ef6\u3067\u30aa\u30fc\u30d5\u30a1\u30f3\u533b\u85ac\u54c1\u304c\u627f\u8a8d\u3055\u308c\u3001\u5e02\u5834\u72ec\u5360\u671f\u9593\u304c\u6709\u52b9\u3067\u3042\u308c\u3070\u3001\u7533\u8acb\u8005\u306f\u627f\u8a8d\u3055\u308c\u305f\u30aa\u30fc\u30d5\u30a1\u30f3\u533b\u85ac\u54c1\u3068\u306e\u985e\u4f3c\u6027\u306e\u53ef\u80fd\u6027\u3092\u691c\u8a0e\u3057\u3001\u985e\u4f3c\u6027\u307e\u305f\u306f\u300c\u975e\u300d\u985e\u4f3c\u6027\u306b\u3064\u3044\u3066\u7d50\u8ad6\u3092\u51fa\u3059\u6279\u5224\u7684\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\uff081.7.1\uff09\u3002\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306e\u5bfe\u8c61\u3068\u306a\u308b\u533b\u85ac\u54c1\u304c\u3001\u4e0a\u8a18\u306e\u5e02\u5834\u72ec\u5360\u6a29\u898f\u5b9a\u306e\u5bfe\u8c61\u3068\u306a\u308b\u30aa\u30fc\u30d5\u30a1\u30f3\u533b\u85ac\u54c1\u3068\u300c\u985e\u4f3c\u300d\u3057\u3066\u3044\u308b\u3068\u307f\u306a\u3055\u308c\u308b\u5834\u5408\u3001\u7533\u8acb\u8005\u306f\u3055\u3089\u306b\u3001\u898f\u5247(EC) No 141\/2000\u306e\u7b2c8.3\u6761(a)\uff5e(c)\u9805\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8efd\u6e1b\u63aa\u7f6e\u306e1\u3064\u3092\u6b63\u5f53\u5316\u3059\u308b\u7406\u7531\u3092\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044(1.7.2)\u3002<\/p>\n<p><strong>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306b\u95a2\u3059\u308b\u60c5\u5831<\/strong> <strong>(\u30bb\u30af\u30b7\u30e7\u30f31.8)<\/strong><\/p>\n<p><strong>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\uff081.8.1\u9805<\/strong><\/p>\n<p>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\uff08Pharmacovigilance\uff09\u3068\u306f\u3001\u526f\u4f5c\u7528\u3084\u305d\u306e\u4ed6\u306e\u85ac\u7269\u95a2\u9023\u306e\u554f\u984c\u3092\u691c\u51fa\u3001\u8a55\u4fa1\u3001\u7406\u89e3\u3001\u4e88\u9632\u3059\u308b\u305f\u3081\u306e\u79d1\u5b66\u3068\u6d3b\u52d5\u306e\u3053\u3068\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u3053\u3068\u306f\u3001\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3057\u3066\u3001\u627f\u8a8d\u524d\u306e\u6bb5\u968e\u3067\u3082\u627f\u8a8d\u5f8c\u306e\u6bb5\u968e\u3067\u3082\u540c\u3058\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306e\u305f\u3081\u306e\u975e\u5e38\u306b\u91cd\u8981\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u3059\u3002<\/p>\n<p>\u6307\u4ee42001\/83\/EC\u306e\u7b2c8\u6761(ia)\u306b\u5f93\u3044\u3001\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u306e\u8a73\u7d30\u306a\u8aac\u660e\u3092\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u8aac\u660e\u306b\u306f\u3001\u7533\u8acb\u8005\u304c\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306b\u8cac\u4efb\u3092\u6301\u3064\u6709\u8cc7\u683c\u8005\u306e\u30b5\u30fc\u30d3\u30b9\u3092\u53d7\u3051\u3066\u3044\u308b\u3053\u3068\u306e\u8a3c\u660e\u3092\u542b\u307e\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p>\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u8005\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u306e\u8a18\u8ff0\u306f\u3001EudraLex \u306e Volume 9A \u306b\u8a73\u8ff0\u3055\u308c\u3066\u3044\u308b\u8981\u4ef6\u3068\u5f62\u5f0f\u306b\u5f93\u3046\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<p><strong>\u30ea\u30b9\u30af\u7ba1\u7406\u4f53\u5236\uff081.8.2\u9805<\/strong><\/p>\n<p>\u30ea\u30b9\u30af\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u8a73\u7d30\u306a\u8aac\u660e\u306f\u3001\u6307\u4ee42001\/83\/EC\u306e\u7b2c8\u6761(ia)\u306b\u5f93\u3063\u3066\u63d0\u4f9b\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u30ea\u30b9\u30af\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u8a73\u7d30\u306a\u8aac\u660e\u306f\u3001EudraLex\u306eVolume 9A\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001EU\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b(EU-RMP)\u306e\u5f62\u3067\u63d0\u4f9b\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<p><strong>\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u9023\u3059\u308b\u60c5\u5831\uff081.9\u9805<\/strong><\/p>\n<p>1.9 \u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u6b27\u5dde\u9023\u5408\u5916\u3067\u5b9f\u65bd\u3055\u308c\u305f\u81e8\u5e8a\u8a66\u9a13\u304c\u6307\u4ee4 2001\/20\/EC \u306e\u502b\u7406\u7684\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u65e8\u306e\u5831\u544a\u66f8\u3092\u3001\u8a72\u5f53\u3059\u308b\u5834\u5408\u306b\u306f\u3001\u6307\u4ee4 2001\/83\/EC \u306e\u7b2c 8 \u6761 (ib) \u306b\u5f93\u3063\u3066\u4f5c\u6210\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u304c\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u305f\u3059\u3079\u3066\u306e\u65b0\u898f\u7533\u8acb\uff08\u5ef6\u9577\u7533\u8acb\u3092\u542b\u3080\uff09\u3001\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u95a2\u9023\u3059\u308b\u627f\u8a8d\u5f8c\u306e\u898f\u5236\u624b\u7d9a\u304d\uff08\u4f8b\uff1a\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\uff09\u306b\u3064\u3044\u3066\u63d0\u4f9b\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<p><strong>\u5c0f\u5150\u79d1\u306b\u95a2\u3059\u308b\u60c5\u5831\uff081.10\u9805<\/strong><\/p>\n<p>Regulation (EC) No 1901\/2006 ('pediatric regulation') \u306e Article 7, 8 and 30 \u304a\u3088\u3073 Regulation (EC) No 1901\/2006 ('pediatric regulation') \u306e Article 23 \u306b\u5f93\u3063\u3066\u3001\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<ul>\n<li>EEA\u3067\u8a8d\u53ef\u3055\u308c\u3066\u3044\u306a\u3044\u533b\u85ac\u54c1\u306e\u3059\u3079\u3066\u306e\u65b0\u898f\u7533\u8acb*\u306b\u3064\u3044\u3066<\/li>\n<li>\u8ffd\u52a0\u4fdd\u8b77\u8a3c\u660e\u66f8\u3001\u307e\u305f\u306f\u305d\u306e\u3088\u3046\u306a\u8a3c\u660e\u66f8\u3092\u4ed8\u4e0e\u3059\u308b\u8cc7\u683c\u306e\u3042\u308b\u7279\u8a31\u306b\u3088\u3063\u3066\u4fdd\u8b77\u3055\u308c\u3066\u3044\u308b\u8a8d\u5b9a\u533b\u85ac\u54c1\u306e\u65b0\u52b9\u80fd\u3001\u65b0\u5264\u5f62\u3001\u65b0\u6295\u4e0e\u7d4c\u8def\u306e\u7533\u8acb*\u306b\u3064\u3044\u3066\u3002<\/li>\n<li>\u5c0f\u5150\u7528\u533b\u85ac\u54c1\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\uff08PUMA\uff09\u306b\u3064\u3044\u3066<\/li>\n<\/ul>\n<p><em>*\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u3001\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u3001\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3001\u78ba\u7acb\u3055\u308c\u305f\u4f7f\u7528\u7528\u9014\u3001\u4f1d\u7d71\u7684\u306a\u30cf\u30fc\u30d6\u3084\u30db\u30e1\u30aa\u30d1\u30b7\u30fc\u306e\u533b\u85ac\u54c1\u3092\u9664\u304f<\/em><\/p>\n<p><strong><em>\u30e2\u30b8\u30e5\u30fc\u30eb1\u306e\u63d0\u4f9b\u304c\u53ef\u80fd\u3067\u3059\u3002<\/em><\/strong><\/p>\n<p><strong>\u8cea\u554f\u3078\u306e\u56de\u7b54<\/strong> \u7533\u8acb\u8005\u304c\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u3001\u5404\u8cea\u554f\u306b\u5bfe\u5fdc\u3059\u308b\u30ca\u30e9\u30c6\u30a3\u30d6\u30c6\u30ad\u30b9\u30c8\u306e\u56de\u7b54\u3092\u542b\u3080\u8cea\u554f\u3092\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3057\u305f\u6587\u66f8\u3092\u542b\u3081\u308b\u3053\u3068\u3092\u52a9\u8a00\u3055\u308c\u3001\u56de\u7b54\u306b\u30e2\u30b8\u30e5\u30fc\u30eb3\u30014\u3001\u304a\u3088\u3073\uff0f\u307e\u305f\u306f5\u306b\u95a2\u9023\u3059\u308b\u65b0\u898f\u307e\u305f\u306f\u66f4\u65b0\u3055\u308c\u305f\u30c7\u30fc\u30bf\uff0f\u6587\u66f8\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u3002\u3053\u306e\u3088\u3046\u306a\u30c7\u30fc\u30bf\uff0f\u8cc7\u6599\u306f\u3001\u3053\u308c\u3089\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u95a2\u9023\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u914d\u7f6e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u8ffd\u52a0\u30c7\u30fc\u30bf\u00a0 <\/strong>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u627f\u8a8d\u624b\u9806\u306b\u57fa\u3065\u3044\u3066\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u8ffd\u52a0\u30c7\u30fc\u30bf\u306f\u3001\u56fd\u5185\u3001\u5206\u6563\u578b\u3001\u307e\u305f\u306f\u76f8\u4e92\u627f\u8a8d\u7533\u8acb\u306e\u4e00\u90e8\u3068\u3057\u3066\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3002                \u305d\u306e\u3088\u3046\u306a\u30c7\u30fc\u30bf\u304c\u30e2\u30b8\u30e5\u30fc\u30eb2\u30013\u30014\u53ca\u3073\uff0f\u53c8\u306f5\u306b\u95a2\u9023\u3059\u308b\u5834\u5408\u3001\u6587\u66f8\u306f\u305d\u308c\u3089\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u95a2\u9023\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u3082\u7f6e\u304b\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u8ffd\u52a0\u30c7\u30fc\u30bf\u306b\u95a2\u3059\u308b\u52a0\u76df\u56fd\u56fa\u6709\u306e\u8981\u6c42\u4e8b\u9805\u306f\u3001\u4ee5\u4e0b\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/ec.europa.eu\/\">\u6b27\u5dde\u59d4\u54e1\u4f1a<\/a>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"CTD-Module_2\"><\/span><a name=\"_Toc71877846\"><\/a><strong>CTD-Module 2<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u533b\u85ac\u54c1\u306e\u4e00\u822c\u7684\u306a\u7d39\u4ecb\u306f\u3001CTD\u6587\u66f8\u306e\u30e2\u30b8\u30e5\u30fc\u30eb2\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u63d0\u4f9b\u3055\u308c\u3001\u3053\u308c\u306f\u3059\u3079\u3066\u306e\u5730\u57df\u3067\u8abf\u548c\u3055\u308c\u3066\u3044\u307e\u3059\uff08The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)\uff09\u3002\u3053\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u3067\u306f\u3001\u54c1\u8cea\u30c7\u30fc\u30bf\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u3068\u3044\u3046\u4eca\u5f8c\u306e\u5404\u30e2\u30b8\u30e5\u30fc\u30eb\u306e\u8981\u7d04\u6587\u66f8\u304c\u63d0\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"CTD-Module_3\"><\/span><a name=\"_Toc71877847\"><\/a><strong>CTD-Module 3<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u30e2\u30b8\u30e5\u30fc\u30eb3\u306f\u3001ICH\u3067\u306fQuality Module\u3068\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u3088\u3046\u306b\u3001\u300c\u54c1\u8cea\u300d\u306fCMC\uff08\u5316\u5b66\u3001\u88fd\u9020\u3001\u7ba1\u7406\uff09\u306e\u4e16\u754c\u7684\u306a\u7528\u8a9e\u3068\u306a\u3063\u305f\u3002<strong>. <\/strong>CMC\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u3001\u4f1a\u793e\u306e\u5185\u90e8\u6587\u66f8\uff08\u4ed5\u69d8\u66f8\u3001\u30d0\u30c3\u30c1\u8a18\u9332\u306a\u3069\uff09\u306e\u8981\u7d20\u3068\u6df7\u540c\u3057\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002<\/p>\n<p>\u307e\u305f\u3001\u30e2\u30b8\u30e5\u30fc\u30eb3\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u5316\u5b66\u7684\u6d3b\u6027\u7269\u8cea\u3068\u751f\u7269\u5b66\u7684\u533b\u85ac\u54c1\u306e\u5316\u5b66\u7684\u30fb\u533b\u85ac\u54c1\u7684\u30fb\u751f\u7269\u5b66\u7684\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u3059\u3079\u3066\u306e\u5730\u57df\u3067\u8abf\u548c\u3092\u56f3\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u958b\u767a\u671f\u9593\u4e2d\u3001\u305d\u3057\u3066\u88fd\u54c1\u304c\u4fdd\u5065\u6240\u306b\u627f\u8a8d\u3055\u308c\u305f\u5f8c\u3082\u3001\u5316\u5b66\u3001\u88fd\u9020\u3001\u7ba1\u7406\uff08CMC\uff09\u306e\u5074\u9762\u306f\u9032\u5316\u3057\u3001\u5909\u5316\u3057\u7d9a\u3051\u307e\u3059\u3002<\/p>\n<p><em>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\uff1dCMC<\/em><\/p>\n<p>CHEMISTRY<\/p>\n<p>\u65b0\u898f\u5316\u5b66\u7269\u8cea\uff0f\u5206\u5b50\u306e\u767a\u898b\u3001\u6709\u52b9\u6210\u5206\uff08\u539f\u85ac\uff09\u306e\u7cbe\u88fd\u3001\u539f\u6750\u6599\u3084\u6700\u7d42\u88fd\u54c1\u306e\u5206\u6790\u8a66\u9a13\u3002<\/p>\n<p>\u88fd\u9020\u696d<\/p>\n<p>\u539f\u85ac\u30fb\u88fd\u5264\u306e\u30e9\u30dc\u30b9\u30b1\u30fc\u30eb\u88fd\u9020\u3001\u81e8\u5e8a\u8a66\u9a13\u7528\u6d88\u8017\u54c1\u306e\u88fd\u9020\u3001\u5546\u7528\u30d0\u30c3\u30c1\u30b5\u30a4\u30ba\u3078\u306e\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u3001\u5546\u7528\u88fd\u54c1\u306e\u88fd\u9020<\/p>\n<p>\u3068\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/p>\n<p>\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u304a\u3088\u3073\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u539f\u85ac\u304a\u3088\u3073\u88fd\u5264\u306e\u9069\u5207\u306a\u4ed5\u69d8\/\u7ba1\u7406\u3092\u7b56\u5b9a\u3059\u308b\u3002<\/p>\n<p>\u3059\u3079\u3066\u306e\u5730\u57df\u3067CMC\/\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u306b\u95a2\u3059\u308b\u66f8\u985e\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u81e8\u5e8a\u8a66\u9a13\u3092\u958b\u59cb\u3057\u3001\u5b9f\u65bd\u3059\u308b\u3002<\/li>\n<li>\u65b0\u898f\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u66f8\uff08MAA\u3001NDA\u3001BLA\u306a\u3069\uff09\u3092\u63d0\u51fa\u3059\u308b\u5834\u5408<\/li>\n<li>\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u304a\u3088\u3073\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u306b\u95a2\u3059\u308b\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b<\/li>\n<\/ul>\n<p>\u3053\u306e\u30e2\u30b8\u30e5\u30fc\u30eb\u306b\u306f\u3001\u539f\u85ac\uff08DS\uff09\u3068\u88fd\u5264\uff08DP\uff09\u306b\u95a2\u3059\u308b\u66f8\u985e\u4e00\u5f0f\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><strong>\u30c9\u30e9\u30c3\u30b0\u30fb\u30b5\u30d6\u30b9\u30bf\u30f3\u30b9\uff08DS<\/strong><\/p>\n<p>\u533b\u85ac\u54c1\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u7269\u7406\u7684\u3001\u5316\u5b66\u7684\u3001\u307e\u305f\u306f\u751f\u7269\u5b66\u7684\u7279\u6027\u3092\u542b\u3080\u8a18\u8ff0\u3001DS\u88fd\u9020\u8005\u306e\u540d\u524d\u3068\u4f4f\u6240\u3001\u8a31\u5bb9\u9650\u754c\u5024\u3001\u304a\u3088\u3073\u533b\u85ac\u54c1\u306e\u540c\u4e00\u6027\u3001\u5f37\u5ea6\u3001\u54c1\u8cea\u3001\u304a\u3088\u3073\u7d14\u5ea6\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u5206\u6790\u65b9\u6cd5\u306b\u3088\u3063\u3066\u63d0\u793a\u3055\u308c\u308b\u3002<\/p>\n<p>\u307e\u305f\u3001\u6bd2\u7269\u5b66\u7684\u8a66\u9a13\u304a\u3088\u3073\u63d0\u6848\u3055\u308c\u3066\u3044\u308b\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306e\u539f\u85ac\u306e\u5b89\u5b9a\u6027\u3092\u88cf\u4ed8\u3051\u308b\u60c5\u5831\u3082\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><strong>\u30c9\u30e9\u30c3\u30b0\u30fb\u30d7\u30ed\u30c0\u30af\u30c8\uff08dp<\/strong><\/p>\n<p>\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u4f7f\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6210\u5206\u306e\u30ea\u30b9\u30c8\uff08\u4e0d\u6d3b\u6027\u5316\u5408\u7269\u306e\u5408\u7406\u7684\u306a\u4ee3\u66ff\u54c1\u3092\u542b\u3080\u5834\u5408\u304c\u3042\u308b\uff09\u3067\u3001\u533b\u85ac\u54c1\u306b\u73fe\u308c\u308b\u3053\u3068\u304c\u610f\u56f3\u3055\u308c\u3066\u3044\u308b\u6210\u5206\u3068\u3001\u73fe\u308c\u306a\u3044\u304b\u3082\u3057\u308c\u306a\u3044\u304c\u88fd\u9020\u5de5\u7a0b\u3067\u4f7f\u7528\u3055\u308c\u308b\u6210\u5206\u306e\u4e21\u65b9\u3092\u542b\u3080\u3082\u306e\u306f\u3001\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002<\/p>\n<p>\u4ee5\u4e0b\u306f\u3001\u85ac\u4e8b\u7533\u8acb\u66f8\u985e\u306b\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u306e\u3042\u308b\u533b\u85ac\u54c1\u306e\u4e3b\u8981\u60c5\u5831\u3067\u3059\u3002<\/p>\n<ul>\n<li>\u5408\u7406\u7684\u306a\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u3092\u542b\u3080\u3001\uff08\u6cbb\u9a13\u85ac\u307e\u305f\u306f\u5e02\u8ca9\u85ac\uff09\u533b\u85ac\u54c1\u306e\u5b9a\u91cf\u7684\u306a\u7d44\u6210\u3002<\/li>\n<li>\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u306e\u540d\u524d\u3068\u4f4f\u6240\u3002<\/li>\n<li>\u88fd\u9020\u304a\u3088\u3073\u30d1\u30c3\u30b1\u30fc\u30b8\u30f3\u30b0\u624b\u9806\u306e\u8aac\u660e<\/li>\n<li>\u533b\u85ac\u54c1\u306e\u540c\u4e00\u6027\u3001\u5f37\u5ea6\u3001\u54c1\u8cea\u3001\u304a\u3088\u3073\u7d14\u5ea6\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u8a31\u5bb9\u9650\u754c\u304a\u3088\u3073\u5206\u6790\u65b9\u6cd5\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"CTD-Module_4\"><\/span><a name=\"_Toc71877848\"><\/a><strong>CTD-Module 4<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u975e\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8<\/strong><\/p>\n<p>\u500b\u3005\u306e\u52d5\u7269\u306e\u30c7\u30fc\u30bf\u306e\u9069\u5207\u306a\u4f4d\u7f6e\u306f\u3001\u898f\u5236\u5f53\u5c40\u306b\u63d0\u51fa\u3055\u308c\u308b\u7533\u8acb\u66f8\u306e\u5171\u901a\u6280\u8853\u6587\u66f8\u306e\u8a66\u9a13\u5831\u544a\u66f8\u306e\u4e2d\u306b\u3042\u308b\u95a2\u9023\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u3059\u3002\u30e2\u30b8\u30e5\u30fc\u30eb4\u306f\u3001ICH\u306e\u539f\u5247\u306b\u57fa\u3065\u3044\u3066\u7c73\u56fd\u304a\u3088\u3073EU\u5411\u3051\u306b\u6574\u5408\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u8a66\u9a13\u5831\u544a\u66f8\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u304a\u3088\u3073\u30b5\u30d6\u30bb\u30af\u30b7\u30e7\u30f3\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 Common Technical Document (CTD)\u306e\u53c2\u8003\u6587\u732e\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"CTD-Module_5\"><\/span><a name=\"_Toc71877849\"><\/a><strong>CTD-Module 5<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8<\/strong><\/p>\n<p>Module 5 section this is the structure and content of clinical study reports.CTD\u306e\u3053\u306e\u90e8\u5206\u306f\u3001\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u767b\u9332\u306e\u305f\u3081\u306e\u5171\u901a\u6280\u8853\u6587\u66f8\uff08CTD\uff09\u5185\u306e\u30d2\u30c8\u30fb\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u3001\u305d\u306e\u4ed6\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u53c2\u8003\u6587\u732e\u3092\u63d0\u793a\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u8981\u7d20\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306e\u6e96\u5099\u3068\u5be9\u67fb\u3092\u5bb9\u6613\u306b\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u30e2\u30b8\u30e5\u30fc\u30eb5\u306f\u3001ICH\u306e\u539f\u5247\u306b\u57fa\u3065\u3044\u3066\u7c73\u56fd\u3068EU\u3067\u6574\u5408\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u8a66\u9a13\u5831\u544a\u66f8\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3068\u30b5\u30d6\u30bb\u30af\u30b7\u30e7\u30f3\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002EU\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u53c2\u7167\u5148 Common Technical Document (CTD).<\/p>\n<blockquote><p>\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u66f8\u985e\u306e\u4f5c\u6210\u306b\u30b5\u30dd\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f\u95b2\u89a7\u30fb\u76f8\u8ac7 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=RegulatoryDossier\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u898f\u5236\u95a2\u9023\u30e9\u30a4\u30bf\u30fc<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002<\/p><\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Additional_References\"><\/span><a name=\"_Toc71877850\"><\/a><strong>\u305d\u306e\u4ed6\u306e\u53c2\u8003\u8cc7\u6599<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><a href=\"https:\/\/www.ich.org\/page\/ctd\">https:\/\/www.ich.org\/page\/ctd<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/media\/128163\/download\">https:\/\/www.fda.gov\/media\/128163\/download<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/media\/135573\/download\">https:\/\/www.fda.gov\/media\/135573\/download<\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/eudralex\/vol-2\/b\/update_200805\/ctd_05-2008_en.pdf\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/eudralex\/vol-2\/b\/update_200805\/ctd_05-2008_en.pdf<\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/eudralex\/vol-1\/dir_2001_83_consol_2012\/dir_2001_83_cons_2012_en.pdf\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/eudralex\/vol-1\/dir_2001_83_consol_2012\/dir_2001_83_cons_2012_en.pdf<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02001L0083-20121116&amp;from=DE\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02001L0083-20121116&amp;from=DE<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02004R0726-20130605&amp;from=EN\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02004R0726-20130605&amp;from=EN<\/a><\/li>\n<li><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/eudralex\/vol-1\/reg_2000_141_cons-2009-07\/reg_2000_141_cons-2009-07_en.pdf\">https:\/\/ec.europa.eu\/health\/sites\/default\/files\/files\/eudralex\/vol-1\/reg_2000_141_cons-2009-07\/reg_2000_141_cons-2009-07_en.pdf<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/clinical-trials-human-medicines\">https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/clinical-trials-human-medicines<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32006R1901\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32006R1901<\/a><\/li>\n<li><a href=\"https:\/\/clinicaltrials.gov\/ct2\/home\">https:\/\/clinicaltrials.gov\/ct2\/home<\/a><\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Nare Simonyan, freelance regulatory affairs specialist at Kolabtree, provides a comprehensive guide to a regulatory dossier and its format. Introduction: What is a regulatory dossier? Regulatory dossier is a package of documents, which may include all required information regarding newly developed drug products and\/or generics, which is required by EU and US regulatory authorities for granting marketing authorization approvals. The main information that is included in the package is administrative information, data related to the quality, safety and efficacy of drug product, which can be submitted by CTD (Common Technical Document) format both paper and electronic version. Since the information submitted in paper format was enormous, agencies are now encouraging<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":9171,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540,653],"tags":[757,756],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What Is Regulatory Dossier and What Does It Contain? - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"What is a regulatory dossier? A comprehensive guide to its structure, format and Common Technical Document (CTD).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What Is Regulatory Dossier and What Does It Contain?\" \/>\n<meta property=\"og:description\" content=\"What is a regulatory dossier? A comprehensive guide to its structure, format and Common Technical Document (CTD).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/what-is-regulatory-dossier-and-what-does-it-contain\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-24T06:13:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-04-18T11:31:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2021\/05\/regulatory-dossier.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1500\" \/>\n\t<meta property=\"og:image:height\" content=\"1000\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"13\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"What Is Regulatory Dossier and What Does It Contain? - The Kolabtree Blog","description":"What is a regulatory dossier? 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