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class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-9213d4e1fa198d10b130ade1345e8465\">EU\u306b\u304a\u3051\u308b\u8ca9\u58f2\u8a31\u53ef\u624b\u7d9a\u304d<\/h2>\n\n\n\n<p>\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3067\u306f\u3001\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u306b\u5411\u3051\u305f\u3055\u307e\u3056\u307e\u306a\u898f\u5236\u624b\u7d9a\u304d\u3092\u63d0\u4f9b\u3057\u3066\u304a\u308a\u3001\u305d\u308c\u305e\u308c\u304c\u7570\u306a\u308b\u7a2e\u985e\u306e\u533b\u85ac\u54c1\u3084\u7279\u5b9a\u306e\u5e02\u5834\u30cb\u30fc\u30ba\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002\u672c\u6982\u8981\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u624b\u7d9a\u304d\u306e\u8a73\u7d30\u306a\u6982\u8981\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-cc8454a6371a4cebea06c18841b2931f\" style=\"font-size:18px\"><strong>1. 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class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-ffb047141d4d8d272360f6e9f51a2e67\" style=\"font-size:18px\"><strong>2. \u5206\u6563\u5be9\u67fb\u304a\u3088\u3073\u76f8\u4e92\u627f\u8a8d\u624b\u7d9a\u304d<\/strong><\/h3>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u624b\u7d9a\u304d\u306f\u3001\u4e2d\u592e\u5be9\u67fb\u624b\u7d9a\u304d\u306e\u5fc5\u9808\u5bfe\u8c61\u5916\u3068\u306a\u308b\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5206\u6563\u5be9\u67fb\u624b\u7d9a\u304d\uff08DCP\uff09<\/strong>\uff1a\u3053\u306e\u624b\u7d9a\u304d\u306f\u3001\u88fd\u54c1\u304c\u307e\u3060EU\u52a0\u76df\u56fd\u306e\u3044\u305a\u308c\u306b\u304a\u3044\u3066\u3082\u627f\u8a8d\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u4f01\u696d\u306f\u7533\u8acb\u3092\u8a55\u4fa1\u3059\u308b\u52a0\u76df\u56fd\uff08\u53c2\u7167\u52a0\u76df\u56fd\u3001RMS\uff09\u30921\u3064\u9078\u3073\u307e\u3059\u3002\u4ed6\u306e\u52a0\u76df\u56fd\uff08\u95a2\u4fc2\u52a0\u76df\u56fd\u3001CMS\uff09\u304c\u95a2\u4e0e\u3057\u3001\u7570\u8b70\u304c\u306a\u3051\u308c\u3070RMS\u306e\u8a55\u4fa1\u304cCMS\u306b\u3088\u3063\u3066\u76f8\u4e92\u627f\u8a8d\u3055\u308c\u3001\u307b\u307c\u540c\u6642\u671f\u306b\u8907\u6570\u306e\u56fd\u3067\u56fd\u5185\u627f\u8a8d\u304c\u5f97\u3089\u308c\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u76f8\u4e92\u627f\u8a8d\u624b\u7d9a\u304d\uff08MRP\uff09<\/strong>\uff1a\u3053\u308c\u306f\u3001\u88fd\u54c1\u304c\u3059\u3067\u306b1\u3064\u306eEU\u52a0\u76df\u56fd\uff08\u5c06\u6765\u306e\u53c2\u7167\u52a0\u76df\u56fd\u3001RMS\uff09\u3067\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u627f\u8a8d\u306e\u4fdd\u6709\u8005\u306f\u3001\u3053\u306e\u627f\u8a8d\u304c\u4ed6\u306eEU\u52a0\u76df\u56fd\uff08\u95a2\u4fc2\u52a0\u76df\u56fd\u3001CMS\uff09\u3067\u8a8d\u3081\u3089\u308c\u308b\u3088\u3046\u7533\u8acb\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u65e2\u5b58\u306e\u5f53\u5c40\u306e\u8a55\u4fa1\u3068\u7533\u8acb\u66f8\u3092\u4ed6\u306e\u52a0\u76df\u56fd\u306b\u63d0\u51fa\u3057\u3001\u5143\u306e\u56fd\u5185\u8ca9\u58f2\u627f\u8a8d\u306e\u6709\u52b9\u6027\u3092\u8a8d\u3081\u3066\u3082\u3089\u3046\u624b\u7d9a\u304d\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-b9bc478f89220f5370a7c25f54af62e1\" style=\"font-size:18px\"><strong>3. \u56fd\u5185\u624b\u7d9a\u304d<\/strong><\/h3>\n\n\n\n<p>\u3053\u306e\u624b\u7d9a\u304d\u306f\u3001\u4f01\u696d\u304c1\u3064\u306eEU\u52a0\u76df\u56fd\u3067\u306e\u307f\u8ca9\u58f2\u627f\u8a8d\u3092\u53d6\u5f97\u3057\u3088\u3046\u3068\u3059\u308b\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u9650\u5b9a\u7684\u306a\u5e02\u5834\u3092\u6301\u3064\u88fd\u54c1\u3084\u3001\u4f01\u696d\u304c\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u306e\u4e8b\u696d\u62e1\u5927\u3092\u958b\u59cb\u3059\u308b\u969b\u306b\u3088\u304f\u9078\u3070\u308c\u307e\u3059\u3002\u7533\u8acb\u306f\u3001\u8ca9\u58f2\u304c\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u56fd\u306e\u56fd\u5185\u306e\u4e3b\u7ba1\u5f53\u5c40\u306b\u63d0\u51fa\u3055\u308c\u3001\u627f\u8a8d\u3055\u308c\u308b\u3068\u3001\u305d\u306e\u8ca9\u58f2\u627f\u8a8d\u306f\u5f53\u8a72\u56fd\u3067\u306e\u307f\u6709\u52b9\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u624b\u7d9a\u304d\u306f\u305d\u308c\u305e\u308c\u7279\u5b9a\u306e\u5229\u70b9\u3092\u63d0\u4f9b\u3057\u3001\u88fd\u85ac\u696d\u754c\u5185\u306e\u7570\u306a\u308b\u6226\u7565\u7684\u30cb\u30fc\u30ba\u306b\u5bfe\u5fdc\u3059\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u88fd\u54c1\u306e\u7279\u6027\u3001\u5bfe\u8c61\u5e02\u5834\u3001\u5546\u696d\u7684\u76ee\u6a19\u306b\u5fdc\u3058\u3066\u3001\u9069\u5207\u306a\u624b\u7d9a\u304d\u7d4c\u8def\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u3053\u306e\u898f\u5236\u7d4c\u8def\u306e\u67d4\u8edf\u6027\u306b\u3088\u308a\u3001\u3059\u3079\u3066\u306e\u7a2e\u985e\u306e\u533b\u85ac\u54c1\u304c\u3001\u6b27\u5dde\u9023\u5408\u5168\u4f53\u3067\u6700\u3082\u52b9\u7387\u7684\u304b\u3064\u9069\u5207\u306a\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u30eb\u30fc\u30c8\u3092\u898b\u3064\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-cover is-light has-parallax\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-white-background-color has-background-dim-30 has-background-dim\"><\/span><div class=\"wp-block-cover__image-background wp-image-19105 has-parallax\" style=\"background-position:50% 50%;background-image:url(https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/medfiles-graphic.jpg)\"><\/div><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" id=\"setup\" style=\"font-size:21px\">\u30b0\u30ed\u30fc\u30d0\u30eb\u88fd\u85ac\u4f01\u696d\u3068Medfiles\uff1aEU\u3067\u306e\u8ca9\u58f2\u627f\u8a8d\u53d6\u5f97\u304a\u3088\u3073\u7dad\u6301\u306b\u304a\u3051\u308b\u652f\u63f4<\/h2>\n\n\n\n<p>\u300cMedfiles\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u306e\u88fd\u54c1\u767b\u9332\u3068\u7dad\u6301\u306e\u969b\u306b\u3001\u79c1\u305f\u3061\u306b\u3068\u3063\u3066\u975e\u5e38\u306b\u8cb4\u91cd\u306a\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u306e\u627f\u8a8d\u306b\u95a2\u9023\u3059\u308b\u554f\u3044\u5408\u308f\u305b\u3084\u61f8\u5ff5\u304c\u3042\u308b\u5834\u5408\u3001\u5e38\u306b\u8fc5\u901f\u304b\u3064\u6b63\u78ba\u306a\u5bfe\u5fdc\u3092\u63d0\u4f9b\u3057\u3066\u304f\u308c\u307e\u3059\u3002\u300d<\/p>\n\n\n\n<p>\u3053\u308c\u306f\u3001Medfiles\u30687\u5e74\u9593\u306b\u308f\u305f\u308a\u5354\u529b\u3057\u3066\u3044\u308bEU\u5916\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u304c\u3001\u3053\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u3092\u3069\u306e\u3088\u3046\u306b\u8868\u73fe\u3057\u3066\u3044\u308b\u304b\u3067\u3059\u3002\u540c\u793e\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u5e02\u5834\u3078\u306e\u53c2\u5165\u652f\u63f4\u304c\u5fc5\u8981\u306b\u306a\u3063\u305f\u969b\u306b\u3001Medfiles\u3078\u306e\u4f9d\u983c\u3092\u958b\u59cb\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u5354\u529b\u306b\u306f\u3001\u65b0\u898f\u306e\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u3084\u3001\u627f\u8a8d\u5f8c\u306e\u88fd\u54c1\u7ba1\u7406\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-font-size has-small-font-size\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/eu%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e8%b2%a9%e5%a3%b2%e8%a8%b1%e5%8f%af%e3%81%ae%e5%8f%96%e5%be%97%e3%81%8a%e3%82%88%e3%81%b3%e7%b6%ad%e6%8c%81%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e6%a5%ad%e5%8b%99\/\">\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u30b9\u30c8\u30fc\u30ea\u30fc\u3092\u8aad\u3080<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-2c2af81573bd8b775c1686192c0b3f38\">\u8ca9\u58f2\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u4e3b\u8981\u306a\u30b9\u30c6\u30c3\u30d7<\/h2>\n\n\n\n<p>EU\u3067\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u5404\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3092\u614e\u91cd\u306b\u8a08\u753b\u3057\u3001\u5b9f\u884c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u8907\u96d1\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u8ca9\u58f2\u627f\u8a8d\u307e\u3067\u306e\u9053\u306e\u308a\u306f\u3001\u88fd\u54c1\u306e\u7a2e\u985e\u3001\u7533\u8acb\u306e\u8907\u96d1\u3055\u3001\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u306b\u5bfe\u3059\u308b\u4f01\u696d\u306e\u5bfe\u5fdc\u901f\u5ea6\u306a\u3069\u306e\u8981\u56e0\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-bf98a42092f3626cbb8c2cca74cda358\" style=\"font-size:18px\"><strong>1. \u7533\u8acb\u524d\u306e\u6d3b\u52d5<\/strong><\/h3>\n\n\n\n<p>\u7533\u8acb\u3092\u63d0\u51fa\u3059\u308b\u524d\u306b\u3001\u4f01\u696d\u306f\u7533\u8acb\u524d\u306e\u6d3b\u52d5\u306b\u5f93\u4e8b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u898f\u5236\u6226\u7565\u3084\u88fd\u54c1\u306b\u95a2\u9023\u3059\u308b\u79d1\u5b66\u7684\u306a\u61f8\u5ff5\u3092\u8a71\u3057\u5408\u3046\u305f\u3081\u3001EMA\uff08\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff09\u3084\u56fd\u5185\u5f53\u5c40\u3068\u306e\u79d1\u5b66\u7684\u52a9\u8a00\u4f1a\u8b70\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u3084\u308a\u53d6\u308a\u306f\u3001\u7279\u306b\u9769\u65b0\u7684\u306a\u88fd\u54c1\u306b\u304a\u3044\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u8a2d\u8a08\u306e\u9069\u5207\u6027\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30ea\u30f3\u30b0\u3001\u30c7\u30fc\u30bf\u8981\u4ef6\u306b\u95a2\u3059\u308b\u8cb4\u91cd\u306a\u6307\u91dd\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-c9c6398ef46cfc41edb54618164943e9\" style=\"font-size:18px\"><strong>2. \u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306e\u63d0\u51fa<\/strong><\/h3>\n\n\n\n<p>\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306f\u3001\u7814\u7a76\u958b\u767a\u6bb5\u968e\u3067\u53ce\u96c6\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u3092\u542b\u3080\u5305\u62ec\u7684\u306a\u66f8\u985e\u3067\u3059\u3002\u3053\u306e\u66f8\u985e\u306b\u5fc5\u8981\u306a\u60c5\u5831\u306f\u3001\u4ee5\u4e0b\u306e\u7ae0\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-b1f9ca5a6eef7f0f8531c2210c6f23a9\" style=\"font-size:18px\"><strong>3.<\/strong> <strong>\u7533\u8acb\u306e\u691c\u8a3c<\/strong><\/h3>\n\n\n\n<p>\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u3092\u53d7\u7406\u3059\u308b\u3068\u3001\u898f\u5236\u5f53\u5c40\u306f\u66f8\u985e\u304c\u5b8c\u5168\u3067\u3042\u308a\u3001\u5fc5\u8981\u306a\u898f\u5236\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3001\u6b20\u843d\u3084\u4e0d\u5b8c\u5168\u306a\u60c5\u5831\u304c\u3042\u308b\u3068\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u304c\u9045\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-f2efcebc38af536587008845c4f5b3ce\" style=\"font-size:18px\"><strong>4. \u79d1\u5b66\u7684\u8a55\u4fa1<\/strong><\/h3>\n\n\n\n<p>\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u63d0\u51fa\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306e\u8a73\u7d30\u306a\u8a55\u4fa1\u304c\u3001EMA\u306e\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a\uff08CHMP\uff09\u3001\u52d5\u7269\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a\uff08CVMP\uff09\u307e\u305f\u306f\u5404\u56fd\u306e\u5c02\u9580\u5bb6\u306b\u3088\u3063\u3066\u884c\u308f\u308c\u307e\u3059\u3002\u3053\u306e\u8a55\u4fa1\u3067\u306f\u3001\u88fd\u54c1\u306e\u6cbb\u7642\u4e0a\u306e\u5229\u76ca\u3068\u30ea\u30b9\u30af\u304c\u691c\u8a0e\u3055\u308c\u307e\u3059\u3002\u901a\u5e38\u3001\u5f53\u5c40\u306f\u7533\u8acb\u8005\u306b\u8ffd\u52a0\u60c5\u5831\u3084\u8aac\u660e\u3092\u6c42\u3081\u308b\u305f\u3081\u3001\u8a55\u4fa1\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u304c\u5ef6\u3073\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-97380f3e28b6223596ebcf048fe4cfbd\" style=\"font-size:18px\"><strong>5. \u6c7a\u5b9a<\/strong><\/h3>\n\n\n\n<p>\u4e2d\u592e\u5be9\u67fb\u624b\u7d9a\u304d\u3067\u306f\u3001CHMP\uff08\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a\uff09\u307e\u305f\u306fCVMP\uff08\u52d5\u7269\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a\uff09\u304c\u3001\u533b\u85ac\u54c1\u3092\u8ca9\u58f2\u3059\u3079\u304d\u304b\u3069\u3046\u304b\u306b\u95a2\u3059\u308b\u79d1\u5b66\u7684\u610f\u898b\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u306e\u610f\u898b\u306f\u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u9001\u3089\u308c\u3001\u6b27\u5dde\u9023\u5408\u5185\u3067\u88fd\u54c1\u3092\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306e\u6700\u7d42\u7684\u306a\u8ca9\u58f2\u627f\u8a8d\u3092\u4e0e\u3048\u308b\u6a29\u9650\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u305d\u306e\u4ed6\u306e\u624b\u7d9a\u304d\u3067\u306f\u3001\u95a2\u4e0e\u3059\u308b\u5404\u56fd\u306e\u4e3b\u7ba1\u5f53\u5c40\u304c\u88fd\u54c1\u306b\u5bfe\u3057\u3066\u8ca9\u58f2\u627f\u8a8d\u3092\u767a\u884c\u3057\u3001\u305d\u306e\u56fd\u3067\u306e\u8ca9\u58f2\u3092\u8a31\u53ef\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-69b3f9c25b7bfef15a1a1ef2cf283d79\" style=\"font-size:18px\"><strong>6.<\/strong> <strong>\u627f\u8a8d\u5f8c\u306e\u76e3\u8996\u3068\u8ca9\u58f2\u627f\u8a8d\u306e\u7dad\u6301<\/strong><\/h3>\n\n\n\n<p>\u88fd\u54c1\u304c\u627f\u8a8d\u3055\u308c\u305f\u5f8c\u3082\u3001\u88fd\u85ac\u4f1a\u793e\u306f\u305d\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5f15\u304d\u7d9a\u304d\u76e3\u8996\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u306f\u3001\u5b9a\u671f\u7684\u306a\u5b89\u5168\u6027\u66f4\u65b0\u5831\u544a\u66f8\u306e\u63d0\u51fa\u3001\u5229\u76ca\u3068\u30ea\u30b9\u30af\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u8ffd\u52a0\u7814\u7a76\u3001\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306b\u7279\u5b9a\u3055\u308c\u306a\u304b\u3063\u305f\u526f\u4f5c\u7528\u3084\u305d\u306e\u4ed6\u306e\u5b89\u5168\u6027\u60c5\u5831\u3092\u691c\u51fa\u3059\u308b\u305f\u3081\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u6d3b\u52d5\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u8ca9\u58f2\u627f\u8a8d\u306e\u4fdd\u6709\u8005\u306f\u3001\u8ca9\u58f2\u627f\u8a8d\u3092\u7a4d\u6975\u7684\u306b\u7dad\u6301\u3059\u308b\u8cac\u4efb\u304c\u3042\u308a\u307e\u3059\u3002\u88fd\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\u66f8\u985e\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3059\u3079\u3066\u306e\u5909\u66f4\u306f\u3001\u30d0\u30ea\u30a8\u30fc\u30b7\u30e7\u30f3\u7533\u8acb\u3092\u4f7f\u7528\u3057\u3066\u4e3b\u7ba1\u5f53\u5c40\u306b\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-background\" style=\"background-color:#f3f3f3\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-daf5b484bd7fa8756499a14808fe29fa\">\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u542b\u3081\u308b\u3079\u304d\u5185\u5bb9<\/h2>\n\n\n\n<p>\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u306f\u3001\u5305\u62ec\u7684\u3067\u3042\u308a\u3001\u898f\u5236\u5f53\u5c40\u304c\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u304a\u3088\u3073\u54c1\u8cea\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u66f8\u985e\u3068\u30c7\u30fc\u30bf\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306e\u5404\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u88fd\u54c1\u306e\u5168\u4f53\u7684\u306a\u8a55\u4fa1\u306b\u304a\u3044\u3066\u91cd\u8981\u3067\u3059\u3002\u30c7\u30fc\u30bf\u306f\u3001\u9069\u7528\u3055\u308c\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3063\u3066\u3001\u660e\u78ba\u304b\u3064\u6574\u7406\u3055\u308c\u305f\u5f62\u5f0f\u3067\u63d0\u793a\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<strong>\u8ca9\u58f2\u627f\u8a8d\u66f8\u985e\u306b\u306f\u3001\u6b21\u306e\u4e3b\u8981\u306a\u8981\u7d20\u304c\u542b\u307e\u308c\u307e\u3059\uff1a<\/strong><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-a1765921494d7190a7a87413b523df74\" style=\"font-size:18px\"><strong>\u54c1\u8cea\u30c7\u30fc\u30bf\uff08\u30e2\u30b8\u30e5\u30fc\u30eb3\uff09<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6709\u52b9\u6210\u5206\u306b\u95a2\u3059\u308b\u60c5\u5831\u3002\u30c7\u30fc\u30bf\u3092\u66f8\u985e\u306b\u542b\u3081\u308b\u65b9\u6cd5\u306f\u3044\u304f\u3064\u304b\u3042\u308a\u3001\u4f8b\u3048\u3070\u6709\u52b9\u6210\u5206\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u3084CEP\uff08\u9069\u5408\u8a3c\u660e\u66f8\uff09\u306a\u3069\u304c\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u533b\u85ac\u54c1\u306e\u88fd\u5264\u3001\u88fd\u9020\u5de5\u7a0b\u3001\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u60c5\u5831\u3002<\/li>\n\n\n\n<li>\u88fd\u9020\u5834\u6240\u3001\u539f\u6750\u6599\u306e\u7ba1\u7406\u3001\u88fd\u54c1\u4ed5\u69d8\u3001\u304a\u3088\u3073\u3055\u307e\u3056\u307e\u306a\u6761\u4ef6\u4e0b\u3067\u306e\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u3092\u7db2\u7f85\u3057\u305f\u66f8\u985e\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-d7c23fc089cf31c1c49c8c2c425d57f1\" style=\"font-size:18px\"><strong>\u975e\u81e8\u5e8a\u30c7\u30fc\u30bf\uff08\u30e2\u30b8\u30e5\u30fc\u30eb4\uff09<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3092\u30d2\u30c8\u3067\u306e\u8a66\u9a13\u524d\u306b\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u85ac\u7406\u5b66\u3001\u6bd2\u6027\u5b66\u3001\u304a\u3088\u3073\u85ac\u7269\u52d5\u614b\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u3002<\/li>\n\n\n\n<li>\u3053\u306e\u6bb5\u968e\u306f\u3001\u88fd\u54c1\u306e\u751f\u7269\u5b66\u7684\u306a\u6319\u52d5\u3092\u7406\u89e3\u3057\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u4e88\u6e2c\u3059\u308b\u305f\u3081\u306b\u91cd\u8981\u3067\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-27da79692e1631a0ad2c1c3af1c2786b\" style=\"font-size:18px\"><strong>\u81e8\u5e8a\u30c7\u30fc\u30bf\uff08\u30e2\u30b8\u30e5\u30fc\u30eb5\uff09<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u793a\u3059\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3002<\/li>\n\n\n\n<li>\u3053\u308c\u3089\u306f\u56fd\u969b\u7684\u306a\u300c\u6cbb\u9a13\u5b9f\u65bd\u306e\u57fa\u6e96\u300d\uff08GCP\uff09\u306b\u6e96\u62e0\u3057\u3001\u591a\u69d8\u306a\u96c6\u56e3\u3092\u542b\u3081\u3066\u7d50\u679c\u306e\u5e45\u5e83\u3044\u9069\u7528\u6027\u3092\u78ba\u4fdd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-3ba7cbe42ec8d07f6716ffdc16949e1e\" style=\"font-size:18px\"><strong>\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\uff08RMP\uff09<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u533b\u85ac\u54c1\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3001\u7279\u5fb4\u4ed8\u3051\u3001\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306e\u5305\u62ec\u7684\u306aRMP\u304c\u5fc5\u8981\u3067\u3059\u3002<\/li>\n\n\n\n<li>\u3053\u308c\u306b\u306f\u3001\u85ac\u7269\u6709\u5bb3\u53cd\u5fdc\uff08ADR\uff09\u3084\u598a\u5a20\u4e2d\u306e\u4f7f\u7528\u306a\u3069\u3001\u4ed6\u306e\u5b89\u5168\u30ea\u30b9\u30af\u3092\u76e3\u8996\u3001\u8a55\u4fa1\u3001\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306e\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u6d3b\u52d5\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-72d59b241e69a691c5abbbb17505f3dc\" style=\"font-size:18px\"><strong>\u88fd\u54c1\u7279\u6027\u6982\u8981\uff08SmPC\uff09\u3001\u30e9\u30d9\u30eb\u8868\u793a\u3001\u304a\u3088\u3073\u6dfb\u4ed8\u6587\u66f8\uff08PL\uff09<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>SmPC\uff1a\u85ac\u5264\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u3001\u9069\u5fdc\u75c7\u3001\u7528\u91cf\u3001\u7981\u5fcc\u4e8b\u9805\u3001\u6f5c\u5728\u7684\u306a\u526f\u4f5c\u7528\u306a\u3069\u3092\u542b\u307f\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u533b\u7642\u5c02\u9580\u5bb6\u304c\u533b\u85ac\u54c1\u3092\u5b89\u5168\u304b\u3064\u52b9\u679c\u7684\u306b\u4f7f\u7528\u3059\u308b\u305f\u3081\u306e\u60c5\u5831\u306e\u57fa\u76e4\u3068\u306a\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>\u30e9\u30d9\u30eb\u8868\u793a\u3068PL\uff1a\u85ac\u5264\u306e\u5305\u88c5\u306b\u8a18\u8f09\u3055\u308c\u308b\u60c5\u5831\u3084\u3001\u60a3\u8005\u5411\u3051\u306e\u6dfb\u4ed8\u6587\u66f8\u306b\u542b\u307e\u308c\u308b\u60c5\u5831\u3067\u3001\u85ac\u3092\u5b89\u5168\u304b\u3064\u52b9\u679c\u7684\u306b\u4f7f\u7528\u3059\u308b\u65b9\u6cd5\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-f13f362974229b32a6f07257d6c4ed77\" style=\"font-size:18px\"><strong>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u5b89\u5168\u7ba1\u7406\u8a08\u753b\u306e\u6982\u8981\uff08PSMF\uff09<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u8cac\u4efb\u8005\uff08QPPV\uff09\u3001PSMF\u756a\u53f7\u3001\u304a\u3088\u3073Article 57\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u767b\u9332\u3055\u308c\u305f\u5834\u6240\u306e\u60c5\u5831\u304c\u63d0\u4f9b\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li>PSMF\u306f\u3001\u4e3b\u7ba1\u5f53\u5c40\u304b\u3089\u306e\u8981\u8acb\u304c\u3042\u3063\u305f\u5834\u5408\u30017\u65e5\u4ee5\u5185\u306b\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/li>\n<\/ul>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" 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style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p style=\"font-size:16px\">Medfiles\u306e\u9ad8\u5ea6\u306a\u5c02\u9580\u77e5\u8b58\u3092\u6301\u3064\u30c1\u30fc\u30e0\u306f\u3001\u5e73\u5747\u3057\u306610\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u308a\u3001\u88fd\u85ac\u696d\u754c\u304a\u3088\u3073\u898f\u5236\u5f53\u5c40\u3067\u306e\u8ca9\u58f2\u627f\u8a8d\u3068\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u7d4c\u9a13\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002\u79c1\u305f\u3061\u3068\u63d0\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u7279\u5b9a\u306e\u30cb\u30fc\u30ba\u306b\u5408\u308f\u305b\u305f\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u30b5\u30fc\u30d3\u30b9\u3092\u5229\u7528\u3067\u304d\u307e\u3059\u3002<strong>\u767b\u9332\u6226\u7565\u304b\u3089\u8ca9\u58f2\u627f\u8a8d\u307e\u3067\u3001EU\u306e\u3069\u306e\u56fd\u306b\u304a\u3044\u3066\u3082\u3001\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\uff08DCP\/MRP\/CP\/NP\uff09\u3092\u304a\u4efb\u305b\u3044\u305f\u3060\u3051\u307e\u3059\u3002\u307e\u305f\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u90e8\u306e\u307f\u3092\u5916\u90e8\u59d4\u8a17\u3059\u308b\u3053\u3068\u3082\u53ef\u80fd\u3067\u3059\u3002<\/strong><\/p>\n\n\n\n<p 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href=\"https:\/\/medfilesgroup.com\/ja\/our-services\/regulatory-affairs-of-human-and-veterinary-medicines\/\">\u85ac\u4e8b\u30b5\u30fc\u30d3\u30b9<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/our-services\/pharmacovigilance-vigilance-service\/\">\u5b89\u5168\u6027\u60c5\u5831\u7ba1\u7406\u30b5\u30fc\u30d3\u30b9<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/contact-us\/contact-form\/\">\u304a\u554f\u3044\u5408\u308f\u305b\u306f\u3053\u3061\u3089\uff1a\u304a\u898b\u7a4d\u308a\u306e\u3054\u4f9d\u983c<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"http:\/\/shorturl.at\/gkpP9\" rel=\"noopener\">\u30c1\u30fc\u30e0\u3068\u306e\u7121\u659930\u5206\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u4e88\u7d04<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/contact-us\/subscribe-newsletter\/\">Medfiles\u306e\u30cb\u30e5\u30fc\u30b9\u30ec\u30bf\u30fc\u3092\u8cfc\u8aad\u3059\u308b<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3067\u533b\u85ac\u54c1\u306e\u8ca9\u58f2\u8a31\u53ef\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f &#8230; <a title=\"EU\u3067\u8ca9\u58f2\u8a31\u53ef\u3092\u53d6\u5f97\u3059\u308b\u65b9\u6cd5 \u2013 \u533b\u85ac\u54c1\u306e\u8981\u4ef6\u304a\u3088\u3073\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\" class=\"read-more\" href=\"https:\/\/medfilesgroup.com\/ja\/eu%e3%81%a7%e8%b2%a9%e5%a3%b2%e8%a8%b1%e5%8f%af%e3%82%92%e5%8f%96%e5%be%97%e3%81%99%e3%82%8b%e6%96%b9%e6%b3%95-%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e8%a6%81%e4%bb%b6%e3%81%8a%e3%82%88\/\" aria-label=\"More on EU\u3067\u8ca9\u58f2\u8a31\u53ef\u3092\u53d6\u5f97\u3059\u308b\u65b9\u6cd5 \u2013 \u533b\u85ac\u54c1\u306e\u8981\u4ef6\u304a\u3088\u3073\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\">Read more<\/a><\/p>\n","protected":false},"author":10,"featured_media":20367,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[316],"tags":[],"product":[],"content_type":[],"service":[],"class_list":["post-17810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-316"],"_links":{"self":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/posts\/17810","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/comments?post=17810"}],"version-history":[{"count":3,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/posts\/17810\/revisions"}],"predecessor-version":[{"id":20370,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/posts\/17810\/revisions\/20370"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/media\/20367"}],"wp:attachment":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/media?parent=17810"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/categories?post=17810"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/tags?post=17810"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/product?post=17810"},{"taxonomy":"content_type","embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/content_type?post=17810"},{"taxonomy":"service","embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/service?post=17810"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}