{"id":1688,"date":"2021-02-24T05:22:30","date_gmt":"2021-02-23T20:22:30","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/covid-19%e3%83%91%e3%83%b3%e3%83%87%e3%83%9f%e3%83%83%e3%82%af%e3%81%ab%e5%af%be%e3%81%99%e3%82%8b%e8%a6%8f%e5%88%b6%e5%af%be%e5%bf%9c3-%e6%b7%b7%e4%b9%b1%e3%82%92%e6%9c%80%e5%b0%8f%e9%99%90\/?lang=ja"},"modified":"2021-02-24T05:22:30","modified_gmt":"2021-02-23T20:22:30","slug":"regulatory-response-to-the-covid-19-pandemic-careful-planning-to-minimize-disruptions-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/regulatory-response-to-the-covid-19-pandemic-careful-planning-to-minimize-disruptions-2\/","title":{"rendered":"COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u5bfe\u3059\u308b\u898f\u5236\u5bfe\u5fdc#3: \u6df7\u4e71\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u614e\u91cd\u306a\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b"},"content":{"rendered":"<p><a href=\"https:\/\/clarivate.com\/cortellis\/article\/regulatory-response-to-the-covid-19-pandemic-careful-planning-to-minimize-disruptions\/\">\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8<\/a><\/p>\n<p><span style=\"font-size: small\">\u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p>\u73fe\u5728\u9032\u884c\u4e2d\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u305d\u306e\u3082\u306e\u306b\u5bfe\u51e6\u3059\u308b\u5fc5\u8981\u6027\u306b\u52a0\u3048\u3066\u3001\u898f\u5236\u5f53\u5c40\u306f\u81e8\u5e8a\u8a66\u9a13\u3084\u4ed6\u75be\u60a3\u306e\u6cbb\u7642\u85ac\u3084\u533b\u85ac\u54c1\u306e\u4e0d\u53ef\u6b20\u306a\u4f9b\u7d66\u3078\u306e\u5f71\u97ff\u306b\u3082\u5bfe\u51e6\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u6700\u5f8c\u306e\u30d6\u30ed\u30b0\u8a18\u4e8b\u3067\u306f\u3001\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u3001\u533b\u85ac\u54c1\u88fd\u9020\u3001\u8840\u6db2\u3084\u81d3\u5668\u306e\u4e0d\u53ef\u6b20\u306a\u4f9b\u7d66\u3078\u306e\u6df7\u4e71\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u3053\u308c\u307e\u3067\u306e\u30b7\u30ea\u30fc\u30ba\u3067\u306f\u3001Cortellis Regulatory Intelligence\u2122 \u306e\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3067\u3042\u308b<strong>Monia Tumminello<\/strong>\u3068\u3001Cortellis Regulatory Intelligence \u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u3067\u3042\u308b<strong>Jaime Polychrones<\/strong>\u304c\u305d\u306e\u6982\u8981\u3092\u8aac\u660e\u3057\u3066\u304d\u307e\u3057\u305f:<\/p>\n<ul>\n<li>\u6cbb\u7642\u6cd5\u306e\u958b\u767a\u304c\u3001\u6b7b\u4ea1\u7387\u306e\u4f4e\u4e0b\u3068\u60a3\u8005\u306e\u30a2\u30a6\u30c8\u30ab\u30e0\u306e\u6539\u5584\u306b\u8ca2\u732e\u3057\u3066\u3044\u308b\u3053\u3068<\/li>\n<li>\u691c\u67fb\u3001\u63a5\u89e6\u8005\u8ffd\u8de1\u3001\u500b\u4eba\u7528\u4fdd\u8b77\u5177\u306e\u7d99\u7d9a\u7684\u306a\u5fc5\u8981\u6027<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u3053\u306e\u30d6\u30ed\u30b0\u30b7\u30ea\u30fc\u30ba\u306e\u6700\u5f8c\u3068\u306a\u308b\u4eca\u56de\u306f\u3001\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u3001\u533b\u85ac\u54c1\u88fd\u9020\u3001\u8840\u6db2\u3084\u81d3\u5668\u306e\u4e0d\u53ef\u6b20\u306a\u4f9b\u7d66\u3078\u306e\u6df7\u4e71\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u6226\u7565\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002\u3053\u308c\u304c\u4e16\u754c\u304c\u7d4c\u9a13\u3059\u308b\u6700\u5f8c\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u3068\u306a\u308b\u53ef\u80fd\u6027\u306f\u4f4e\u3044\u3068\u8a8d\u8b58\u3057\u3001\u5404\u56fd\u653f\u5e9c\u306f\u5c06\u6765\u306b\u5411\u3051\u3066\u3088\u308a\u5927\u304d\u306a\u5099\u3048\u3092\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u4e2d\u65ad\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b<\/strong><\/h3>\n<p>\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306b\u767a\u751f\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u9694\u96e2\u3084\u65bd\u8a2d\u9589\u9396\u3001\u6e21\u822a\u5236\u9650\u3001\u6cbb\u9a13\u85ac\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u5bf8\u65ad\u3001\u4eba\u54e1\u3084\u53c2\u52a0\u8005\u306e\u611f\u67d3\u3068\u3044\u3046\u61f8\u5ff5\u306e\u4e2d\u3067\u3001\u4ed6\u306e\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u3069\u306e\u3088\u3046\u306b\u7d99\u7d9a\u3059\u308b\u304b\u3068\u3044\u3046\u6f5c\u5728\u7684\u306a\u8ab2\u984c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f<a href=\"https:\/\/www.fda.gov\/media\/136238\/download\" target=\"_blank\" rel=\"noopener\">COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306e\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u306b\u5bfe\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\u3092\u516c\u8868\u3057\u3001\u305d\u308c\u4ee5\u964d\u66f4\u65b0\u3092\u7d9a\u3051\u3066\u304d\u307e\u3057\u305f\u3002\u3055\u3089\u306b\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\uff08EC\uff09\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u3001\u5404\u56fd\u306e\u533b\u85ac\u54c1\u5e81\u9577\uff08HMA\uff09\u306f\u3001<a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/guidanceclinicaltrials_covid19_en.pdf\" target=\"_blank\" rel=\"noopener\">COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7ba1\u7406\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u8ab2\u984c\u306f\u3001\u8a66\u9a13\u8a55\u4fa1\u306e\u5b8c\u4e86\u3001\u8a66\u9a13\u8a2a\u554f\u306e\u5b8c\u4e86\u3001\u6cbb\u9a13\u85ac\uff08IMP\uff09\u306e\u63d0\u4f9b\u306a\u3069\u306e\u8a66\u9a13\u5b9f\u65bd\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<blockquote><p><strong>FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u308a\u3001\u7c73\u56fd\u3067\u5b9f\u65bd\u3055\u308c\u308b\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u7c73\u56fd\u306e\u898f\u5236\u3092\u9075\u5b88\u3057\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u6761\u4ef6\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8abf\u6574\u3057\u3066\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/strong><\/p>\n<p>&nbsp;<\/p><\/blockquote>\n<p>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u3084\u9038\u8131\u306b\u5bfe\u51e6\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u306e\u60c5\u5831\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u8a66\u9a13\u53c2\u52a0\u8005\u306e\u5b89\u5168\u6027\u306e\u78ba\u4fdd<\/li>\n<li>\u9069\u6b63\u81e8\u5e8a\u691c\u67fb\u5b9f\u65bd\u57fa\u6e96\uff08GCP\uff09\u306e\u9075\u5b88\u3092\u7dad\u6301\u3057\u3001<\/li>\n<li>\u8a66\u9a13\u306e\u5b8c\u5168\u6027\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b<\/li>\n<\/ul>\n<p>\u8a66\u9a13\u53c2\u52a0\u8005\u306f\u3001\u53c2\u52a0\u3057\u3066\u3044\u308b\u8a66\u9a13\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u5e38\u306b\u77e5\u3089\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>\u60a3\u8005\u306e\u5b89\u5168\u6027\u304c\u6700\u512a\u5148\u4e8b\u9805\u3067\u3042\u308b\u305f\u3081\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u96fb\u8a71\u3084\u30d0\u30fc\u30c1\u30e3\u30eb\u9762\u8ac7\u3001\u307e\u305f\u306f\u5225\u306e\u5834\u6240\u3067\u5b89\u5168\u6027\u8a55\u4fa1\u306b\u53c2\u52a0\u3059\u308b\u65b9\u304c\u60a3\u8005\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u3079\u304d\u3067\u3042\u308b\uff08\u305d\u308c\u3089\u304c\u8a66\u9a13\u306b\u304a\u3044\u3066\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u5834\u5408\uff09\u3002<\/strong><\/p>\n<p>&nbsp;<\/p><\/blockquote>\n<p>\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u3001\u53ef\u53ca\u7684\u901f\u3084\u304b\u306b\u6a5f\u95a2\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\uff0f\u72ec\u7acb \u502b\u7406\u59d4\u54e1\u4f1a\uff08IEC\uff09\u306b\u901a\u77e5\u3059\u3079\u304d\u3067\u3059\u3002\u53c2\u52a0\u8005\u306e\u5065\u5eb7\u3084\u751f\u547d\u304c\u5371\u967a\u306b\u3055\u3089\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u306e\u3088\u3046\u306a\u5909\u66f4\u306fIRB\u306e\u627f\u8a8d\u306a\u3057\u306b\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u305d\u306e\u5f8c\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u304c\u3042\u3063\u305f\u5834\u5408\u306b\u306f\u3001\u9069\u5207\u306a\u5be9\u67fb\u90e8\u9580\u306b\u76f8\u8ac7\u3057\u3066\u6709\u52b9\u6027\u8a55\u4fa1\u3092\u691c\u8a0e\u3059\u3079\u304d\u3067\u3059\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001\u5ef6\u671f\u304c\u9069\u5207\u306a\u5834\u5408\u3082\u3042\u308b\u3057\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u53c2\u52a0\u8005\u306e\u52df\u96c6\u3092\u505c\u6b62\u3059\u308b\u304b\u3001\u53c2\u52a0\u8005\u3092\u64a4\u56de\u3059\u308b\u3053\u3068\u3092\u9078\u629e\u3059\u308b\u5834\u5408\u3082\u3042\u308a\u307e\u3059\u3002\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u9069\u5207\u306a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u8a18\u8f09\u3059\u308b\u304b\u3001\u5225\u306e\u6587\u66f8\u306b\u8a18\u8f09\u3059\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5b9f\u65bd\u3055\u308c\u305f\u7dca\u6025\u6642\u5bfe\u7b56;<\/li>\n<li>COVID-19\u306b\u95a2\u9023\u3059\u308b\u8a66\u9a13\u4e2d\u65ad\u306e\u5f71\u97ff\u3092\u53d7\u3051\u305f\u5168\u53c2\u52a0\u8005\u30ea\u30b9\u30c8\u3068\u3001\u305d\u306e\u53c2\u52a0\u8005\u53d7\u3051\u305f\u5f71\u97ff<\/li>\n<li>\u5831\u544a\u3055\u308c\u305f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u7d50\u679c\u306b\u5bfe\u3059\u308b\u5076\u767a\u7684\u63aa\u7f6e\u306b\u95a2\u3059\u308b\u5f71\u97ff\u306e\u5206\u6790<\/li>\n<\/ul>\n<p>IMP\u3092\u53d6\u308a\u5dfb\u304f\u73fe\u5b9f\u7684\u306a\u8003\u616e\u4e8b\u9805\u306b\u306f\u3001\u53c2\u52a0\u8005\u306e\u81ea\u5b85\u3067\u6295\u4e0e\u30fb\u4fdd\u7ba1\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3001\u8f38\u9001\u4e2d\u306b\u88fd\u54c1\u306e\u5b89\u5b9a\u6027\u304c\u3069\u306e\u3088\u3046\u306b\u7dad\u6301\u3055\u308c\u308b\u304b\u3001\u88fd\u54c1\u306e\u5b89\u5168\u306a\u4fdd\u7ba1\u304c\u3069\u306e\u3088\u3046\u306b\u78ba\u4fdd\u3055\u308c\u308b\u304b\u3001IMP\u306e\u8aac\u660e\u8cac\u4efb\u3068\u6cbb\u7642\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u8a55\u4fa1\u304c\u3069\u306e\u3088\u3046\u306b\u7ba1\u7406\u3055\u308c\u308b\u304b\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p>FDA \u306f\u3001\u73fe\u5728\u78ba\u7acb\u3055\u308c\u3066\u3044\u308b\u81e8\u5e8a\u8a66\u9a13\u306b\u3064\u3044\u3066\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306b\u53c2\u52a0\u8005\u304c\u3069\u306e\u3088\u3046\u306b\u4fdd\u8b77\u3055\u308c\u3001\u8a66\u9a13\u304c\u4e2d\u65ad\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u5834\u5408\u306b\u3069\u306e\u3088\u3046\u306b\u7ba1\u7406\u3055\u308c\u308b\u304b\u3092\u8aac\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u65b9\u91dd\u3068\u624b\u9806\u3092\u6539\u8a02\u307e\u305f\u306f\u4f5c\u6210\u3059\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u3001\u8a66\u9a13\u8a2a\u554f\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u3001\u8a66\u9a13\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u3001COVID-19\u306e\u767a\u75c5\u306b\u3088\u308b\u30b9\u30bf\u30c3\u30d5\u306e\u5909\u66f4\u306e\u53ef\u80fd\u6027\u3078\u306e\u5f71\u97ff\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>\u85ac\u5264\u306e\u627f\u8a8d\u306b\u306f\u3001\u304c\u3093\u3001\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u75c5\u3001HIV\u306a\u3069\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n<p>&nbsp;<\/p><\/blockquote>\n<p>COVID-19\u4ee5\u5916\u306b\u3082\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u75be\u60a3\u6cbb\u7642\u306b\u91cd\u8981\u306a\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u7533\u8acb\u306e\u5be9\u67fb\u3092\u7d99\u7d9a\u3057\u307e\u3057\u305f\u3002<\/p>\n<ul>\n<li>\u30d5\u30a1\u30fc\u30b9\u30c8\u30e9\u30a4\u30f3\u306e\u30d7\u30e9\u30c1\u30ca\u88fd\u5264\u3092\u542b\u3080\u5316\u5b66\u7642\u6cd5\u3067\u9032\u884c\u3057\u3066\u3044\u306a\u3044\u5c40\u6240\u9032\u884c\u6027\u307e\u305f\u306f\u8ee2\u79fb\u6027\u306e\u5c3f\u8def\u304c\u3093\u60a3\u8005\u306e\u305f\u3081\u306e\u65b0\u3057\u3044\u7dad\u6301\u7642\u6cd5\u3068\u3057\u3066<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2020\/761049Orig1s009.pdf\" target=\"_blank\" rel=\"noopener\">avelumab\u306e\u65b0\u305f\u306a\u52b9\u80fd\u30fb\u52b9\u679c<\/a>\u3092\u8ffd\u52a0<\/li>\n<li>HER2\u967d\u6027\u4e73\u304c\u3093\u3092\u5bfe\u8c61\u306b\u3001<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-breast-cancer-treatment-can-be-administered-home-health-care-professional\" target=\"_blank\" rel=\"noopener\">\u533b\u7642\u5f93\u4e8b\u8005\u304c\u5728\u5b85\u3067\u6295\u4e0e\u53ef\u80fd\u306a\u30da\u30eb\u30c4\u30ba\u30de\u30d6\u3001\u30c8\u30e9\u30b9\u30c4\u30ba\u30de\u30d6\u3001\u30d2\u30a2\u30eb\u30ed\u30cb\u30c0\u30fc\u30bc\u3092\u914d\u5408\u3057\u305f\u76ae\u4e0b\u6ce8\u5c04\u5264PHESGO<\/a><\/li>\n<li>\u8ee2\u79fb\u3057\u305f\u975e\u5c0f\u7d30\u80de\u80ba\u304c\u3093\uff08NSCLC\uff09\u306e\u6210\u4eba\u60a3\u8005\u3092\u5bfe\u8c61\u3068\u3057\u305f\u521d\u306e\u6a19\u7684\u6cbb\u7642\u85ac<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-targeted-therapy-treat-aggressive-form-lung-cancer\" target=\"_blank\" rel=\"noopener\">capmatinib<\/a><\/li>\n<li>\u30a2\u30eb\u30c4\u30cf\u30a4\u30de\u30fc\u578b\u8a8d\u77e5\u75c7\u304c\u7591\u308f\u308c\u308b\u6210\u4eba\u60a3\u8005\u306e\u8133\u306ePET\u753b\u50cf\u8a3a\u65ad\u306b\u4f7f\u7528\u3059\u308b<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&amp;varApplNo=212123\" target=\"_blank\" rel=\"noopener\">flortaucipir<\/a><\/li>\n<li>\u6210\u4eba\u304a\u3088\u3073\u5c0f\u5150\u60a3\u8005\u306b\u304a\u3051\u308bHIV-1\u611f\u67d3\u75c7\u306e\u6cbb\u7642\u306e\u305f\u3081\u306e\u4ed6\u306e\u6297\u30ec\u30c8\u30ed\u30a6\u30a4\u30eb\u30b9\u5264\u3068\u306e\u4f75\u7528\u306b\u3088\u308b<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&amp;ApplNo=213983\" target=\"_blank\" rel=\"noopener\">dolutegravir<\/a><\/li>\n<li>\u305d\u306e\u4ed6<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30d2\u30c8\u7531\u6765\u7269\u8cea (SoHO): \u5b89\u5168\u3067\u5341\u5206\u304b\u3064\u30a2\u30af\u30bb\u30b9\u53ef\u80fd\u306a\u4f9b\u7d66\u3092\u7dad\u6301\u3059\u308b\u3053\u3068<\/strong><\/h3>\n<p>COVID-19\u306b\u95a2\u9023\u3059\u308b\u5b89\u5168\u5bfe\u7b56\u3068\u3057\u3066\u3001\u793e\u4f1a\u7684\u306a\u8ddd\u96e2\u3092\u7f6e\u304f\u306a\u3069\u306e\u5bfe\u7b56\u3092\u884c\u3063\u305f\u7d50\u679c\u3001\u8840\u6db2\u88fd\u5264\u3084\u305d\u306e\u4ed6\u306e\u30d2\u30c8\u7531\u6765\u7269\u8cea\uff08SoHO\uff09\u306e\u4f9b\u7d66\u91cf\u304c\u6e1b\u5c11\u3057\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u8840\u6db2\u3084\u4f53\u6db2\u4e2d\u306bCOVID-19\u30a6\u30a4\u30eb\u30b9\u304c\u5b58\u5728\u3057\u3001\u8f38\u8840\u3084\u79fb\u690d\u3092\u4ecb\u3057\u3066\u611f\u67d3\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u304c\u61f8\u5ff5\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>\u8840\u6db2\u88fd\u5264\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u30d2\u30c8\u7531\u6765\u7269\u8cea\uff08SoHO\uff09\u306f\u3001\u81ea\u5b85\u5f85\u6a5f\u547d\u4ee4\u3084\u8840\u6db2\u30fb\u4f53\u6db2\u4e2d\u306eSARS-CoV-2\u30a6\u30a4\u30eb\u30b9\u306e\u5b58\u5728\u304c\u61f8\u5ff5\u3055\u308c\u3001\u4f9b\u7d66\u304c\u4e0d\u8db3\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n<p>&nbsp;<\/p><\/blockquote>\n<p>FDA\u306f\u3001SoHO\u306e\u4f9b\u7d66\u4e0d\u8db3\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u8f38\u8840\u306b\u3088\u308b<a href=\"https:\/\/www.fda.gov\/media\/92490\/download\" target=\"_blank\" rel=\"noopener\">HIV<\/a>\u304a\u3088\u3073<a href=\"https:\/\/www.fda.gov\/media\/72243\/download\" target=\"_blank\" rel=\"noopener\">\u30de\u30e9\u30ea\u30a2\u611f\u67d3<\/a>\u306e\u30ea\u30b9\u30af\u306b\u95a2\u3059\u308b\u63a8\u5968\u4e8b\u9805\u3092\u6539\u8a02\u3057\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u3057\u3001\u5fc5\u8981\u306a\u691c\u75ab\u6642\u9593\u306e\u77ed\u7e2e\u306a\u3069\u8840\u6db2\u304a\u3088\u3073\u8840\u6db2\u6210\u5206\u306e<a href=\"https:\/\/www.fda.gov\/media\/136603\/download\" target=\"_blank\" rel=\"noopener\">\u4ee3\u66ff\u624b\u9806<\/a>\u3092\u8a18\u8ff0\u3057\u3066\u3001\u30c9\u30ca\u30fc\u306e\u5065\u5eb7\u3092\u5341\u5206\u306b\u4fdd\u8b77\u3057\u3001\u60a3\u8005\u3078\u306e\u5b89\u5168\u306a\u8840\u6db2\u4f9b\u7d66\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u4f9b\u7d66\u53ef\u80fd\u6027\u3092\u5411\u4e0a\u3055\u305b\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u7cde\u4fbf\u4e2d\u306e\u30a6\u30a4\u30eb\u30b9\u306e\u5b58\u5728\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8e0f\u307e\u3048\u3001FDA\u306f\u81e8\u5e8a\u8a66\u9a13\u3084\u60a3\u8005\u30b1\u30a2\u306b\u304a\u3051\u308b\u7cde\u4fbf\u5fae\u751f\u7269\u79fb\u690d\u306e<a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/safety-availability-biologics\/safety-alert-regarding-use-fecal-microbiota-transplantation-and-additional-safety-protections\" target=\"_blank\" rel=\"noopener\">\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u6ce8\u610f\u4e8b\u9805<\/a>\u3082\u793a\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u307e\u305f\u3001\u6b27\u5dde\u75be\u75c5\u4e88\u9632\u7ba1\u7406\u30bb\u30f3\u30bf\u30fc\uff08ECDC\uff09\u306f\u3001SoHO\u306e\u5b89\u5168\u3067\u6301\u7d9a\u53ef\u80fd\u306a\u4f9b\u7d66\u306e\u305f\u3081\u306e\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u7ba1\u7406\u306e\u9078\u629e\u80a2\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3059\u308bCOVID-19\u3068SoHO\u306b\u95a2\u3059\u308b<a href=\"https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/covid-19-supply-substances-human-origin-second-update.pdf\" target=\"_blank\" rel=\"noopener\">\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8<\/a>\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001COVID-19\u304c\u8840\u6db2\u3084\u81d3\u5668\u79fb\u690d\u60a3\u8005\u306b\u3082\u305f\u3089\u3059\u30ea\u30b9\u30af\u3001SoHO\u4f9b\u7d66\u306e\u5341\u5206\u6027\u3068\u6301\u7d9a\u53ef\u80fd\u6027\u3092\u5206\u6790\u3057\u3001SoHO\u306e\u5fae\u751f\u7269\u7684\u5b89\u5168\u6027\u3092\u7de9\u548c\u3059\u308b\u305f\u3081\u306e\u4e88\u9632\u63aa\u7f6e\u3092\u691c\u8a0e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u56de\u5fa9\u671f\u8840\u6f3f\u304cCOVID-19\u60a3\u8005\u306e\u6f5c\u5728\u7684\u306a\u6cbb\u7642\u6cd5\u3068\u3057\u3066\u6d6e\u4e0a\u3057\u305f\u305f\u3081\u3001\u4e21\u6a5f\u95a2\u306fCOVID-19\u56de\u5fa9\u671f\u8840\u6f3f\u306e\u63d0\u4f9b\u3001\u53ce\u96c6\u3001\u691c\u67fb\u3001\u51e6\u7406\u3001\u4fdd\u7ba1\u3001\u6d41\u901a\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7b56\u5b9a\u3057\u3001\u516c\u8868\u3057\u307e\u3057\u305f\uff08<a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/investigational-new-drug-ind-or-device-exemption-ide-process-cber\/recommendations-investigational-covid-19-convalescent-plasma\" target=\"_blank\" rel=\"noopener\">FDA\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff1b<a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/blood_tissues_organs\/docs\/guidance_plasma_covid19_en.pdf\" target=\"_blank\" rel=\"noopener\">EC\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\uff09\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u533b\u85ac\u54c1\u306e\u88fd\u9020\u30fb\u4f9b\u7d66\u3078\u306e\u5f71\u97ff\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b<\/strong><\/h3>\n<p>\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u9593\u3001\u7d99\u7d9a\u7684\u306b\u61f8\u5ff5\u3055\u308c\u3066\u3044\u308b\u306e\u306f\u3001\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3078\u306e\u6f5c\u5728\u7684\u306a\u5f71\u97ff\u3067\u3042\u308a\u3001\u533b\u85ac\u54c1\u3084\u751f\u7269\u5b66\u7684\u88fd\u54c1\u306e\u4f9b\u7d66\u306e\u6df7\u4e71\u3084\u4e0d\u8db3\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002FDA\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u88fd\u54c1\u306e\u4e0d\u8db3\u3092\u9632\u6b62\u307e\u305f\u306f\u7de9\u548c\u3059\u308b\u305f\u3081\u306b\u3001\u7279\u5b9a\u306e\u533b\u85ac\u54c1\u304a\u3088\u3073\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u751f\u7523\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u3001\u88fd\u9020\u696d\u8005\u304cFDA\u306b\u30bf\u30a4\u30e0\u30ea\u30fc\u3067\u6709\u76ca\u306a\u901a\u77e5\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306e<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/notifying-fda-permanent-discontinuance-or-interruption-manufacturing-under-section-506c-fdc-act\" target=\"_blank\" rel=\"noopener\">\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002EMA\u3082\u540c\u69d8\u306b\u4e0d\u8db3\u3084\u6df7\u4e71\u306e\u30ea\u30b9\u30af\u304c\u6700\u3082\u9ad8\u3044\u533b\u85ac\u54c1\u3092\u7279\u5b9a\u3057\u3001\u6539\u5584\u63aa\u7f6e\u306e\u512a\u5148\u9806\u4f4d\u3092\u3064\u3051\u308b\u305f\u3081\u306b\u3001<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/addressing-potential-impact-novel-coronavirus-disease-covid-19-medicines-supply-eu\" target=\"_blank\" rel=\"noopener\">\u88fd\u9020\u60c5\u5831\u306e\u30ec\u30d3\u30e5\u30fc\u3092\u8fc5\u901f\u306b\u958b\u59cb<\/a>\u3057\u307e\u3057\u305f\u3002EU\u52a0\u76df\u56fd\u306f\u3001\u91cd\u8981\u306a\u533b\u85ac\u54c1\u306e\u5c06\u6765\u306e\u9700\u8981\u3092\u4e88\u6e2c\u3059\u308b\u305f\u3081\u306b\u73fe\u5728\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-6https:\/\/www.ema.europa.eu\/en\/news\/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-6\" target=\"_blank\" rel=\"noopener\">\u30e2\u30c7\u30eb\u3092\u5171\u6709<\/a>\u3057\u3001\u4e88\u6e2c\u80fd\u529b\u3092\u5411\u4e0a\u3055\u305b\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u8b70\u8ad6\u3057\u3001\u30c7\u30fc\u30bf\u30e2\u30c7\u30ea\u30f3\u30b0\u306b\u95a2\u3059\u308b\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u691c\u8a0e\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3051\u308b\u5c06\u6765\u306e\u6df7\u4e71\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u3001\u4f01\u696d\u306f\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u898b\u76f4\u3057\u3092\u884c\u3044\u3001\u5730\u7406\u7684\u30fb\u80fd\u529b\u7684\u306b\u591a\u69d8\u5316\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n<p>&nbsp;<\/p><\/blockquote>\n<p>\u307e\u305f\u3001\u3042\u308b\u5730\u57df\u3067\u306e\u6df7\u4e71\u306e\u5f71\u97ff\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u3001\u5c11\u306a\u304f\u3068\u3082\u90e8\u5206\u7684\u306a\u4f9b\u7d66\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3001\u5730\u7406\u7684\u306a\u5834\u6240\u3068\u5bb9\u91cf\u306e\u9762\u3067\u591a\u69d8\u5316\u3059\u308b\u6a5f\u4f1a\u3092\u6c42\u3081\u3066\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u898b\u76f4\u3057\u3092\u59cb\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u4eca\u5f8c<\/strong><\/h3>\n<p>\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306f\u3001\u533b\u85ac\u54c1\u306e\u4f9b\u7d66\u3060\u3051\u3067\u306a\u304f\u3001\u305d\u306e\u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u306b\u6f5c\u5728\u7684\u306a\u8106\u5f31\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u6d6e\u304d\u5f6b\u308a\u306b\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u6a5f\u4f1a\u306b\u3001\u653f\u5e9c\u3084\u898f\u5236\u5f53\u5c40\u306f\u5c06\u6765\u306e\u5927\u6d41\u884c\u6642\u306b\u540c\u3058\u3088\u3046\u306a\u6df7\u4e71\u3084\u516c\u8846\u885b\u751f\u3078\u306e\u5f71\u97ff\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306b\u3001\u30d7\u30ed\u30bb\u30b9\u3084\u624b\u7d9a\u304d\u3092\u898b\u76f4\u3057\u5f37\u5316\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_20_2173\" target=\"_blank\" rel=\"noopener\">\u6b27\u5dde\u306e\u533b\u85ac\u54c1\u6226\u7565<\/a>\u306b\u306f\u3001\u4eca\u5f8c\u6570\u5e74\u9593\u306e\u7acb\u6cd5\u63aa\u7f6e\u3068\u975e\u7acb\u6cd5\u63aa\u7f6e\u306e\u30a2\u30b8\u30a7\u30f3\u30c0\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5c06\u6765\u6027\u304c\u3042\u308a\u6280\u8853\u9769\u65b0\u306b\u914d\u616e\u3057\u305f\u85ac\u4e8b\u57fa\u672c\u6cd5\u306e\u6539\u6b63<\/li>\n<li>EU\u4fdd\u5065\u7dca\u6025\u5bfe\u5fdc\u6a5f\u95a2\u306e\u63d0\u6848<\/li>\n<li>\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308b\u8106\u5f31\u6027\u3092\u7279\u5b9a\u3057\u3001\u4f9b\u7d66\u306e\u7d99\u7d9a\u6027\u3068\u5b89\u5168\u6027\u3092\u5f37\u5316\u3059\u308b\u305f\u3081\u306e\u653f\u7b56\u30aa\u30d7\u30b7\u30e7\u30f3\u3092\u7b56\u5b9a\u3059\u308b\u305f\u3081\u306e\u3001\u533b\u85ac\u54c1\u88fd\u9020\u696d\u306b\u95a2\u3059\u308b\u5168\u54e1\u3068\u516c\u7684\u6a5f\u95a2\u3068\u306e\u9593\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u5bfe\u8a71<\/li>\n<li>\u533b\u85ac\u54c1\u306e\u624b\u9803\u306a\u4fa1\u683c\u3068\u8cbb\u7528\u5bfe\u52b9\u679c\u3092\u5411\u4e0a\u3055\u305b\u3001\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306e\u6301\u7d9a\u53ef\u80fd\u6027\u3092\u5411\u4e0a\u3055\u305b\u307e\u3059\u3002<\/li>\n<li>\u5805\u7262\u306a\u30c7\u30b8\u30bf\u30eb\u30a4\u30f3\u30d5\u30e9<\/li>\n<li>\u7814\u7a76\u30fb\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u652f\u63f4<\/li>\n<li>\u6297\u83cc\u85ac\u3068\u305d\u306e\u4ee3\u66ff\u54c1\u306e\u7814\u7a76\u958b\u767a\u3068\u516c\u5171\u8abf\u9054\u306e\u9769\u65b0\u7684\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u63a8\u9032\u3068\u4f7f\u7528\u5236\u9650\u3068\u6700\u9069\u5316\u306e\u305f\u3081\u306e\u5bfe\u7b56<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u56fd\u5883\u3092\u8d8a\u3048\u305f\u5065\u5eb7\u306b\u5bfe\u3059\u308b\u6df1\u523b\u306a\u8105\u5a01\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306b\u3001EC\u306f\u5099\u3048\u306e\u5f37\u5316\u3001\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u306e\u5f37\u5316\u3001\u4fdd\u5065\u30b7\u30b9\u30c6\u30e0\u6307\u6a19\u306e\u30c7\u30fc\u30bf\u5831\u544a\u306e\u6539\u5584\u3001\u5371\u6a5f\u95a2\u9023\u88fd\u54c1\u306e\u5099\u84c4\u3068\u8abf\u9054\u306e\u305f\u3081\u306e<a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_20_2041\" target=\"_blank\" rel=\"noopener\">\u65b0\u305f\u306a\u67a0\u7d44\u307f\u3092\u63d0\u6848<\/a>\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u30ec\u30b8\u30ea\u30a8\u30f3\u30c8\u306a\u533b\u7642\u3068\u30bd\u30fc\u30b7\u30e3\u30eb\u30b1\u30a2\u306e\u958b\u767a\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001EC\u306f<a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/expert_panel\/docs\/026_health_socialcare_covid19_en.pdf\" target=\"_blank\" rel=\"noopener\">\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb\u306e\u610f\u898b\u66f8<\/a>\u3092\u767a\u8868\u3057\u3001\u4ee5\u4e0b\u306e\u63d0\u8a00\u3092\u691c\u8a0e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u9069\u5fdc\u529b\u306e\u3042\u308b\u30b5\u30fc\u30b8\u80fd\u529b\u306e\u5275\u51fa<\/li>\n<li>\u30d7\u30e9\u30a4\u30de\u30ea\u30fc\u30b1\u30a2\u3068\u30e1\u30f3\u30bf\u30eb\u30d8\u30eb\u30b9\u3078\u306e\u6295\u8cc7<\/li>\n<li>\u60a3\u8005\u30c7\u30fc\u30bf\u306e\u96c6\u8a08\u3092\u884c\u3044\u3001\u516c\u5e73\u6027\u3092\u91cd\u8996\u3057\u305f\u78ba\u5b9f\u306a\u610f\u601d\u6c7a\u5b9a<\/li>\n<li>\u8aa4\u5831\u3092\u76e3\u8996\u3057\u3001\u6e1b\u5c11\u3055\u305b\u308b\u305f\u3081\u306e\u6226\u7565\u8a55\u4fa1<\/li>\n<li>\u793e\u4f1a\u5168\u4f53\u3092\u7d71\u5408\u3057\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u6cbf\u3063\u3066\u3001\u30b7\u30b9\u30c6\u30e0\u3084\u30bb\u30af\u30bf\u30fc\u9593\u3067\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ea\u30f3\u30af<\/li>\n<li>\u793e\u4f1a\u7684\u306b\u56f0\u7aae\u3057\u3066\u3044\u308b\u4eba\u3084\u30de\u30a4\u30ce\u30ea\u30c6\u30a3\u30b0\u30eb\u30fc\u30d7\u3078\u306e\u5bfe\u5fdc\u306b\u95a2\u3059\u308b\u5177\u4f53\u7684\u306a\u7814\u4fee\u306e\u63d0\u4f9b<\/li>\n<li>\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306e\u305f\u3081\u306e\u8010\u969c\u5bb3\u6027\u30c6\u30b9\u30c8\u30c4\u30fc\u30eb\u30ad\u30c3\u30c8\u3068\u5b9f\u65bd\u65b9\u6cd5\u306e\u958b\u767a<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u304c\u9375\u3068\u306a\u308b<\/strong><\/h3>\n<p>COVID-19\u306f\u6025\u901f\u306b\u9032\u5316\u3057\u7d9a\u3051\u308b\u72b6\u6cc1\u3067\u3042\u308a\u3001\u898f\u5236\u5f53\u5c40\u306f\u533b\u7642\u5206\u91ce\u5168\u4f53\u3067\u306e\u8ab2\u984c\u3092\u514b\u670d\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u5f15\u304d\u7d9a\u304d\u4e16\u754c\u7684\u306a\u5bfe\u5fdc\u304c\u8abf\u6574\u3055\u308c\u3001\u8fc5\u901f\u304b\u3064\u5354\u529b\u7684\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306f\u3001\u79c1\u305f\u3061\u306e\u5065\u5eb7\u3068\u5065\u5eb7\u306e\u6210\u679c\u304c\u3001\u96a3\u4eba\u3084\u305d\u306e\u80fd\u529b\u3068\u30ea\u30f3\u30af\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u601d\u3044\u51fa\u3055\u305b\u3066\u304f\u308c\u307e\u3057\u305f\u3002\u79c1\u305f\u3061\u306f\u7686\u3001\u3053\u306e\u554f\u984c\u306b\u4e00\u7dd2\u306b\u95a2\u308f\u3063\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><em>\u898f\u5236\u8981\u4ef6\u306e\u6700\u65b0\u60c5\u5831\u3092\u5165\u624b\u3057\u3001\u7533\u8acb\u306b\u8981\u3059\u308b\u6642\u9593\u3092\u7bc0\u7d04\u3059\u308b\u306b\u306f\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/chemistry-manufacturing-controls-intelligence-analysis\/\">clarivate.com\/cortelliscmc<\/a> \u306b\u30a2\u30af\u30bb\u30b9\u3057\u3001COVID-19 \u306b\u95a2\u9023\u3059\u308b\u8ffd\u52a0\u306e\u66f4\u65b0\u60c5\u5831\u3084\u6700\u65b0\u306e\u30cb\u30e5\u30fc\u30b9\u306b\u3064\u3044\u3066\u306f\u3001\u5f15\u304d\u7d9a\u304d\u30d6\u30ed\u30b0\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8 \u672c\u8a18\u4e8b\u306f\u82f1\u6587\u30d6\u30ed\u30b0\u3092\u65e5\u672c\u8a9e\u306b\u7ffb\u8a33\u518d\u7de8\u96c6\uff08\u4e00\u90e8\u8ffd\u8a18\u3092\u542b\u3080\uff09\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u8a18\u4e8b\u306e\u6b63\u5f0f\u8a00\u8a9e\u306f\u82f1\u8a9e\u3067\u3042\u308a\u3001\u305d\u306e\u5185\u5bb9\u30fb\u89e3\u91c8\u306b\u3064\u3044\u3066\u306f\u82f1\u8a9e\u304c\u512a\u5148\u3057\u307e\u3059\u3002 &nbsp; \u73fe\u5728\u9032\u884c\u4e2d\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u305d\u306e\u3082\u306e\u306b\u5bfe\u51e6\u3059\u308b\u5fc5\u8981\u6027\u306b\u52a0\u3048\u3066\u3001\u898f\u5236\u5f53\u5c40\u306f\u81e8\u5e8a\u8a66\u9a13\u3084\u4ed6\u75be\u60a3\u306e\u6cbb\u7642\u85ac\u3084\u533b\u85ac\u54c1\u306e\u4e0d\u53ef\u6b20\u306a\u4f9b\u7d66\u3078\u306e\u5f71\u97ff\u306b\u3082\u5bfe\u51e6\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u6700\u5f8c\u306e\u30d6\u30ed\u30b0\u8a18\u4e8b\u3067\u306f\u3001\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u3001\u533b\u85ac\u54c1\u88fd\u9020\u3001\u8840\u6db2\u3084\u81d3\u5668\u306e\u4e0d\u53ef\u6b20\u306a\u4f9b\u7d66\u3078\u306e\u6df7\u4e71\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u8aac\u660e\u3057\u307e\u3059\u3002 &nbsp; \u3053\u308c\u307e\u3067\u306e\u30b7\u30ea\u30fc\u30ba\u3067\u306f\u3001Cortellis Regulatory Intelligence\u2122 \u306e\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3067\u3042\u308bMonia Tumminello\u3068\u3001Cortellis Regulatory Intelligence \u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u3067\u3042\u308bJaime Polychrones\u304c\u305d\u306e\u6982\u8981\u3092\u8aac\u660e\u3057\u3066\u304d\u307e\u3057\u305f: \u6cbb\u7642\u6cd5\u306e\u958b\u767a\u304c\u3001\u6b7b\u4ea1\u7387\u306e\u4f4e\u4e0b\u3068\u60a3\u8005\u306e\u30a2\u30a6\u30c8\u30ab\u30e0\u306e\u6539\u5584\u306b\u8ca2\u732e\u3057\u3066\u3044\u308b\u3053\u3068 \u691c\u67fb\u3001\u63a5\u89e6\u8005\u8ffd\u8de1\u3001\u500b\u4eba\u7528\u4fdd\u8b77\u5177\u306e\u7d99\u7d9a\u7684\u306a\u5fc5\u8981\u6027 &nbsp; \u3053\u306e\u30d6\u30ed\u30b0\u30b7\u30ea\u30fc\u30ba\u306e\u6700\u5f8c\u3068\u306a\u308b\u4eca\u56de\u306f\u3001\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u3001\u533b\u85ac\u54c1\u88fd\u9020\u3001\u8840\u6db2\u3084\u81d3\u5668\u306e\u4e0d\u53ef\u6b20\u306a\u4f9b\u7d66\u3078\u306e\u6df7\u4e71\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306e\u6226\u7565\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002\u3053\u308c\u304c\u4e16\u754c\u304c\u7d4c\u9a13\u3059\u308b\u6700\u5f8c\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u3068\u306a\u308b\u53ef\u80fd\u6027\u306f\u4f4e\u3044\u3068\u8a8d\u8b58\u3057\u3001\u5404\u56fd\u653f\u5e9c\u306f\u5c06\u6765\u306b\u5411\u3051\u3066\u3088\u308a\u5927\u304d\u306a\u5099\u3048\u3092\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002 &nbsp; &nbsp; \u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u4e2d\u65ad\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b \u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306b\u767a\u751f\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u9694\u96e2\u3084\u65bd\u8a2d\u9589\u9396\u3001\u6e21\u822a\u5236\u9650\u3001\u6cbb\u9a13\u85ac\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u5bf8\u65ad\u3001\u4eba\u54e1\u3084\u53c2\u52a0\u8005\u306e\u611f\u67d3\u3068\u3044\u3046\u61f8\u5ff5\u306e\u4e2d\u3067\u3001\u4ed6\u306e\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u3069\u306e\u3088\u3046\u306b\u7d99\u7d9a\u3059\u308b\u304b\u3068\u3044\u3046\u6f5c\u5728\u7684\u306a\u8ab2\u984c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306fCOVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306e\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u306b\u5bfe\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u8868\u3057\u3001\u305d\u308c\u4ee5\u964d\u66f4\u65b0\u3092\u7d9a\u3051\u3066\u304d\u307e\u3057\u305f\u3002\u3055\u3089\u306b\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\uff08EC\uff09\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u3001\u5404\u56fd\u306e\u533b\u85ac\u54c1\u5e81\u9577\uff08HMA\uff09\u306f\u3001COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7ba1\u7406\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u8ab2\u984c\u306f\u3001\u8a66\u9a13\u8a55\u4fa1\u306e\u5b8c\u4e86\u3001\u8a66\u9a13\u8a2a\u554f\u306e\u5b8c\u4e86\u3001\u6cbb\u9a13\u85ac\uff08IMP\uff09\u306e\u63d0\u4f9b\u306a\u3069\u306e\u8a66\u9a13\u5b9f\u65bd\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002 FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u308a\u3001\u7c73\u56fd\u3067\u5b9f\u65bd\u3055\u308c\u308b\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u7c73\u56fd\u306e\u898f\u5236\u3092\u9075\u5b88\u3057\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u6761\u4ef6\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8abf\u6574\u3057\u3066\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 &nbsp; \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u3084\u9038\u8131\u306b\u5bfe\u51e6\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u306e\u60c5\u5831\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002 \u8a66\u9a13\u53c2\u52a0\u8005\u306e\u5b89\u5168\u6027\u306e\u78ba\u4fdd \u9069\u6b63\u81e8\u5e8a\u691c\u67fb\u5b9f\u65bd\u57fa\u6e96\uff08GCP\uff09\u306e\u9075\u5b88\u3092\u7dad\u6301\u3057\u3001 \u8a66\u9a13\u306e\u5b8c\u5168\u6027\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b \u8a66\u9a13\u53c2\u52a0\u8005\u306f\u3001\u53c2\u52a0\u3057\u3066\u3044\u308b\u8a66\u9a13\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u5e38\u306b\u77e5\u3089\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308a\u307e\u3059\u3002 &nbsp;&#8230;<\/p>\n","protected":false},"author":161,"featured_media":1689,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1071,1073],"tags":[],"class_list":["post-1688","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-cortellis"],"acf":[],"lang":"ja","translations":{"ja":1688},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1688","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/161"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=1688"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1688\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=1688"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1688"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1688"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}