{"id":1691,"date":"2021-02-24T05:17:35","date_gmt":"2021-02-23T20:17:35","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%9c1-%e6%b2%bb%e7%99%82%e6%b3%95%e3%81%ae%e3%83%95%e3%82%a1\/?lang=ja"},"modified":"2021-02-24T05:17:35","modified_gmt":"2021-02-23T20:17:35","slug":"regulatory-response-to-the-covid-19-pandemic-fast-tracking-therapeutics-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/regulatory-response-to-the-covid-19-pandemic-fast-tracking-therapeutics-2\/","title":{"rendered":"COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u5bfe\u3059\u308b\u898f\u5236\u5bfe\u5fdc#1: \u6cbb\u7642\u6cd5\u306e\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30ad\u30f3\u30b0"},"content":{"rendered":"<p><a href=\"https:\/\/clarivate.com\/cortellis\/article\/regulatory-response-to-the-covid-19-pandemic-fast-tracking-therapeutics\/\">\u82f1\u8a9e\u539f\u6587\u30b5\u30a4\u30c8<\/a><\/p>\n<p><font size=\"2\">\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<\/font><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19 \u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u7d42\u606f\u306b\u5411\u3051\u305f\u53d6\u308a\u7d44\u307f\u306f\u591a\u9762\u7684\u306b\u884c\u308f\u308c\u3066\u304a\u308a\u3001\u75ab\u5b66\u7684\u30c7\u30fc\u30bf\u306e\u628a\u63e1\u3001\u4e88\u9632\u306e\u305f\u3081\u306e\u30ef\u30af\u30c1\u30f3\u3084\u975e\u533b\u85ac\u54c1\u306b\u3088\u308b\u4ecb\u5165\u3001\u6cbb\u7642\u306e\u305f\u3081\u306e\u65b0\u85ac\u3084\u518d\u5229\u7528\u85ac\u306e\u958b\u767a\u306a\u3069\u3001\u591a\u5c90\u306b\u308f\u305f\u3063\u3066\u3044\u307e\u3059\u3002 \u4eca\u56de\u306e\u30d6\u30ed\u30b0\u8a18\u4e8b\u3067\u306f\u3001Cortellis Regulatory Intelligence\u2122\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306e<strong>Monia Tumminello<\/strong>\u3068Cortellis Regulatory Intelligence\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e<strong>Jaime Polychrones<\/strong>\u304c\u3001\u65b0\u305f\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u767a\u884c\u304b\u3089\u65e9\u671f\u627f\u8a8d\u3001\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u306b\u81f3\u308b\u307e\u3067\u3001\u6cbb\u7642\u85ac\u958b\u767a\u306b\u304a\u3051\u308b\u898f\u5236\u5f53\u5c40\u306e\u5bfe\u5fdc\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19 \u30ef\u30af\u30c1\u30f3\u306e\u958b\u767a\u3068\u6295\u4e0e\u306f\u3001\u8fc5\u901f\u306a\u627f\u8a8d\u53d6\u5f97\u3068\u88fd\u9020\u30fb\u8ca9\u58f2\u3078\u306e\u6295\u8cc7\u306e\u9023\u643a\u306b\u3088\u308a\u3001\u6025\u901f\u306b\u9032\u5c55\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u5f93\u4e8b\u8005\u304cCOVID-19\u3067\u60a3\u8005\u3055\u3093\u3092\u30b1\u30a2\u3059\u308b\u4e2d\u3067\u3001\u6cbb\u7642\u6cd5\u306e\u7814\u7a76\uff08\u516c\u5f0f\u30fb\u975e\u516c\u5f0f\u3092\u554f\u308f\u305a\uff09\u306e\u30b9\u30d4\u30fc\u30c9\u3082\u3053\u308c\u307e\u3067\u306b\u306a\u3044\u3082\u306e\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u533b\u85ac\u54c1\u306e\u958b\u767a\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3084\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u304c\u30ef\u30af\u30c1\u30f3\u958b\u767a\u306e\u305f\u3081\u306b\u63d0\u4f9b\u3057\u3066\u3044\u308b\u652f\u63f4\u7b56\u306e\u591a\u304f\u3082\u3001\u7121\u6599\u306e\u79d1\u5b66\u7684\u30a2\u30c9\u30d0\u30a4\u30b9\u3001\u52a0\u901f\u8a55\u4fa1\u3001\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u627f\u8a8d\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u65bd\u7b56\u3068\u3001\u305d\u306e\u767a\u5c55\u304c\u3069\u306e\u3088\u3046\u306b\u6cbb\u7642\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u767a\u5c55\u3057\u3066\u304d\u305f\u306e\u304b\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u65b0\u305f\u306a\u898f\u5236\u4e0a\u306e\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong><\/h3>\n<p>\u65e9\u304f\u30822020\u5e745\u6708\u306b\u306f\u3001FDA\u306f\u3001\u65b0\u85ac\u3084\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u8a66\u9a13\u958b\u59cb\u306e\u305f\u3081\u306e\u7533\u8acb\u66f8\u306e\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u3092\u3088\u308a\u52b9\u7387\u7684\u306b\u3059\u308b\u305f\u3081\u306e\u7814\u7a76\u8005\u5411\u3051\u306e\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u65b0\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306e\u63a8\u5968\u4e8b\u9805\u3082\u6982\u8aac\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/covid-19-public-health-emergency-general-considerations-pre-ind-meeting-requests-covid-19-related\" target=\"_blank\" rel=\"noopener\">COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products<\/a>\u300d\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u3088\u308a\u8fc5\u901f\u306b\u81e8\u5e8a\u8a66\u9a13\u3092\u958b\u59cb\u3067\u304d\u308b\u3088\u3046\u306b\u3001\u88cf\u4ed8\u3051\u3068\u306a\u308b\u30c7\u30fc\u30bf\u306b\u95a2\u3059\u308b\u6a5f\u95a2\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u53d7\u3051\u308b\u305f\u3081\u306e\u3088\u308a\u52b9\u7387\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u306e\u6982\u8981\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u300c<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/covid-19-developing-drugs-and-biological-products-treatment-or-prevention\" target=\"_blank\" rel=\"noopener\">COVID-19: Developing Drugs and Biological Products for Treatment or Prevention<\/a>\u300d\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u5f8c\u671f\u8a66\u9a13\u306b\u304a\u3051\u308b\u6cbb\u9a13\u85ac\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u30ec\u30d3\u30e5\u30fc\u3059\u308b\u305f\u3081\u306e\u73fe\u5728\u306e\u63a8\u5968\u4e8b\u9805\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>EMA\u304c\u627f\u8a8d\u3057\u305f<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/international-regulators-provide-guiding-principles-covid-19-clinical-trials\" target=\"_blank\" rel=\"noopener\">\u5171\u540c\u58f0\u660e<\/a>\u306e\u4e2d\u3067\u3001\u56fd\u969b\u7684\u306a\u533b\u85ac\u54c1\u898f\u5236\u5f53\u5c40\u306f\u3001COVID-19\u306b\u5bfe\u3059\u308b\u6f5c\u5728\u7684\u306a\u6cbb\u7642\u85ac\u306e\u65e9\u671f\u627f\u8a8d\u3092\u53ef\u80fd\u306b\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6c7a\u5b9a\u7684\u306a\u8a3c\u62e0\u3092\u751f\u307f\u51fa\u3059\u53ef\u80fd\u6027\u306e\u9ad8\u3044\u81e8\u5e8a\u8a66\u9a13\u306e\u4e3b\u306a\u7279\u5fb4\u3092\u8aac\u660e\u3057\u307e\u3057\u305f\u3002EMA\u306f\u307e\u305f\u3001COVID-19\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306e\u305f\u3081\u306b\u5b9f\u65bd\u3055\u308c\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u306b\u95a2\u3059\u308b<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/global-regulatory-workshop-covid-19-therapeutics-2-agreement-acceptable-endpoints-clinical-trials\" target=\"_blank\" rel=\"noopener\">\u56fd\u969b\u7684\u306b\u4f5c\u6210\u3057\u305f\u5831\u544a\u66f8<\/a>\u306b\u3082\u5354\u529b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u304c\u9375<\/strong><\/h3>\n<p>\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5171\u540c\u7814\u7a76\u3082\u884c\u308f\u308c\u3066\u3044\u307e\u3059\u3002\u30ef\u30af\u30c1\u30f3\u306b\u52a0\u3048\u3066\u3001National Institutes of Health (NIH) \u306eAccelerating COVID-19 Therapeutic Interventions and Vaccines\uff08ACTIV\uff09\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u306f\u3001\u6cbb\u7642\u6cd5\u306e\u958b\u767a\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002\u540c\u69d8\u306b\u3001<a href=\"https:\/\/www.who.int\/initiatives\/act-accelerator\" target=\"_blank\" rel=\"noopener\">Access to COVID-19 Tools (ACT) Accelerator<\/a>\u306f\u3001COVID-19\u8a66\u9a13\u3001\u6cbb\u7642\u6cd5\u3001\u30ef\u30af\u30c1\u30f3\u3078\u306e\u958b\u767a\u3001\u751f\u7523\u3001\u516c\u5e73\u306a\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3059\u308b\u305f\u3081\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5171\u540c\u7814\u7a76\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>ACT\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u653f\u5e9c\u3001\u79d1\u5b66\u8005\u3001\u4f01\u696d\u3001\u5e02\u6c11\u793e\u4f1a\u3001\u6148\u5584\u5bb6\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30d8\u30eb\u30b9\u7d44\u7e54\u304c\u4e00\u5802\u306b\u4f1a\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>2020\u5e744\u6708\u672b\u306b\u958b\u59cb\u3055\u308c\u305fACT\u30a2\u30af\u30bb\u30e9\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u653f\u5e9c\u3001\u79d1\u5b66\u8005\u3001\u4f01\u696d\u3001\u5e02\u6c11\u793e\u4f1a\u3001\u6148\u5584\u5bb6\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30d8\u30eb\u30b9\u7d44\u7e54\u304c\u4e00\u5802\u306b\u4f1a\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u30d3\u30eb\uff06\u30e1\u30ea\u30f3\u30c0\u30fb\u30b2\u30a4\u30c4\u8ca1\u56e3\u3001Coalition for Epidemic Preparedness Innovations (CEPI)\u3001FIND\u3001Gavi\u3001The Global Fund\u3001Unitaid\u3001Wellcome\u3001\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\u3001\u4e16\u754c\u9280\u884c\u3001Global Financing Facility\u304c\u53c2\u52a0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>EMA\u306eHuman Medicines Committee\uff08CHMP\uff09\u306f<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/call-pool-research-resources-large-multi-centre-multi-arm-clinical-trials-generate-sound-evidence\" target=\"_blank\" rel=\"noopener\">\u58f0\u660e<\/a>\u3092\u767a\u8868\u3057\u3001COVID-19\u306e\u6f5c\u5728\u7684\u306a\u6cbb\u7642\u6cd5\u306e\u8fc5\u901f\u306a\u958b\u767a\u3068\u627f\u8a8d\u3092\u53ef\u80fd\u306b\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6c7a\u5b9a\u7684\u306a\u8a3c\u62e0\u304c\u5f97\u3089\u308c\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u5927\u898f\u6a21\u7121\u4f5c\u70ba\u5316\u6bd4\u8f03\u8a66\u9a13\u3092\u512a\u5148\u3059\u308b\u3088\u3046\u3001EU\u306e\u7814\u7a76\u30b3\u30df\u30e5\u30cb\u30c6\u30a3\u306b\u4fc3\u3057\u307e\u3057\u305f\u3002\u672c\u58f0\u660e\u306f\u3001\u5229\u7528\u53ef\u80fd\u306a\u6cbb\u9a13\u85ac\u306e\u4f9b\u7d66\u3092\u6700\u5927\u9650\u306b\u6d3b\u7528\u3059\u308b\u305f\u3081\u306b\u3001EU\u5168\u4f53\u3067COVID-19\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u3078\u306e\u8abf\u548c\u306e\u3068\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u5805\u7262\u306a\u65b9\u6cd5\u8ad6\u3092\u63a8\u9032\u3057\u3066\u3044\u308b\u3002\u307e\u305f\u3001\u3053\u308c\u3089\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u306f\u3059\u3079\u3066\u306eEU\u8af8\u56fd\u3092\u53c2\u52a0\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001FDA\u306f\u3001<a href=\"https:\/\/www.fda.gov\/drugs\/coronavirus-covid-19-drugs\/coronavirus-treatment-acceleration-program-ctap\" target=\"_blank\" rel=\"noopener\">\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u6cbb\u7642\u52a0\u901f\u30d7\u30ed\u30b0\u30e9\u30e0\uff08CTAP\uff09<\/a>\u3068\u547c\u3070\u308c\u308bCOVID-19\u6cbb\u7642\u306e\u305f\u3081\u306e\u7279\u5225\u306a\u7dca\u6025\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u5275\u8a2d\u3057\u3001\u6cbb\u7642\u6cd5\u306e\u958b\u767a\u3092\u8fc5\u901f\u5316\u3057\u3001\u9023\u90a6\u653f\u5e9c\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u3001\u958b\u767a\u8005\u3001\u7814\u7a76\u8005\u306e\u9593\u3067\u52aa\u529b\u3092\u5408\u7406\u5316\u3057\u307e\u3057\u305f\u3002\u540c\u30b5\u30a4\u30c8\u306b\u3088\u308b\u3068\u30012021\u5e741\u67085\u65e5\u73fe\u5728\u3001\u8a08\u753b\u6bb5\u968e\u306b\u3042\u308b\u85ac\u5264\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u306f590\u4ef6\u4ee5\u4e0a\u3001FDA\u306b\u3088\u308b\u5be9\u67fb\u3092\u53d7\u3051\u305f\u8a66\u9a13\u306f390\u4ef6\u4ee5\u4e0a\u3001\u7dca\u6025\u6642\u306e\u4f7f\u7528\u304c\u627f\u8a8d\u3055\u308c\u305fCOVID-19\u6cbb\u7642\u85ac\u306f8\u4ef6\u3001COVID-19\u6cbb\u7642\u85ac\u3068\u3057\u3066FDA\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u6cbb\u7642\u85ac\u306f1\u4ef6\u3068\u306a\u3063\u3066\u3044\u308b\u3002<\/p>\n<blockquote><p><strong>2021\u5e741\u67085\u65e5\u73fe\u5728\u3001\u8a08\u753b\u6bb5\u968e\u306b\u3042\u308b\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u306f590\u4ee5\u4e0a\u3001FDA\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u3092\u53d7\u3051\u305f\u8a66\u9a13\u306f390\u4ee5\u4e0a\u3001\u7dca\u6025\u6642\u306e\u4f7f\u7528\u3092\u627f\u8a8d\u3055\u308c\u305fCOVID-19\u6cbb\u7642\u85ac\u306f8\u4ef6\u3001COVID-19\u3067\u306e\u4f7f\u7528\u3092FDA\u304c\u627f\u8a8d\u3057\u3066\u3044\u308b\u6cbb\u7642\u85ac\u306f1\u4ef6\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p><strong>\u8fc5\u901f\u306a\u5be9\u67fb\u3068\u627f\u8a8d<\/strong><\/p>\n<p>\u7dca\u6025\u6642\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u306f\u3001FDA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5f8c\u306bEUA\u306e\u5bfe\u8c61\u3068\u306a\u308b\u4e00\u90e8\u60a3\u8005\u3078\u306e\u4f7f\u7528\u304c\u627f\u8a8d\u3055\u308c\u305fremdesivir<\/li>\n<li>\u6301\u7d9a\u7684\u306a\u8f38\u6db2\u306b\u3088\u308b\u93ae\u9759\u306e\u7dad\u6301\u3092\u76ee\u7684\u3068\u3057\u305fFresenius Kabi Propoven;<\/li>\n<li>\u814e\u4ee3\u66ff\u7642\u6cd5\uff08CRRT\uff09\u3092\u7d99\u7d9a\u7684\u306b\u53d7\u3051\u3066\u3044\u308b\u6210\u4eba\u60a3\u8005\u5411\u3051\u306eREGIOCIT\u88dc\u5145\u6db2<\/li>\n<li>\u56de\u5fa9\u671f\u8840\u6f3f;<\/li>\n<li>bamlanivimab;<\/li>\n<li>baricitinib\u3068remdesivir\u306e\u4f75\u7528\u7642\u6cd5\u304a\u3088\u3073<\/li>\n<li>casirivimab\u3068imdevimab\u306e\u4f75\u7528\u7642\u6cd5<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>2021\u5e741\u67084\u65e5\u73fe\u5728\u300171\u306e\u6cbb\u7642\u6cd5\u304cEMA\u304b\u3089\u52a9\u8a00\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>2021\u5e741\u67084\u65e5\u73fe\u5728\u300171\u306e\u6cbb\u7642\u85ac\u304c<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/coronavirus-disease-covid-19\/treatments-vaccines-covid-19#medicines-undergoing-evaluation-section\" target=\"_blank\" rel=\"noopener\">EMA\u304b\u3089\u52a9\u8a00<\/a>\u3092\u53d7\u3051\u3066\u304a\u308a\u3001\u6700\u7d42\u7684\u306a\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u5411\u3051\u3066\u6e96\u5099\u3092\u9032\u3081\u3066\u3044\u307e\u3059\u3002EMA\u306f\u30ec\u30e0\u30c7\u30b7\u30d3\u30eb\u306b\u3064\u3044\u3066\u6761\u4ef6\u4ed8\u304d\u8ca9\u58f2\u8a31\u53ef\u3092\u4e0e\u3048\u3001\u30c7\u30ad\u30b5\u30e1\u30bf\u30be\u30f3\u306b\u3064\u3044\u3066\u306f\u547c\u5438\u5668\u30b5\u30dd\u30fc\u30c8\u3092\u5fc5\u8981\u3068\u3059\u308b\u6210\u4eba\u306eCOVID-19\u306e\u6cbb\u7642\u85ac\u3068\u3057\u3066\u627f\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u6cbb\u7642\u6cd5\u958b\u767a\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u304c\u65e9\u307e\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u8003\u3048\u3001EMA\u3068FDA\u306e\u4e21\u65b9\u304b\u3089\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\u3092\u7528\u3044\u305f\u89b3\u5bdf\u7814\u7a76\u304c\u63d0\u6848\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001COVID-19\u6cbb\u7642\u85ac\u306e\u958b\u767a\u3001\u627f\u8a8d\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u304a\u3051\u308b\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3068\u610f\u601d\u6c7a\u5b9a\u306e\u6709\u52b9\u6027\u3068\u52b9\u7387\u6027\u3092\u9ad8\u3081\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u81e8\u5e8a\u8a66\u9a13\u3067\u306f\u5bfe\u5fdc\u3067\u304d\u306a\u3044\u77e5\u8b58\u306e\u30ae\u30e3\u30c3\u30d7\u306b\u3082\u5bfe\u5fdc\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u75ab\u5b66\u30fb\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u30bb\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\uff08ENCePP\uff09\u3068EMA\u306f\u3001\u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u306b\u5bfe\u3057\u3001COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u95a2\u9023\u3057\u305f\u533b\u85ac\u54c1\u75ab\u5b66\u7684\u7814\u7a76\u3092EU\u306e\u627f\u8a8d\u5f8c\u8a66\u9a13\uff08PAS\uff09\u767b\u9332\u306b\u767b\u9332\u3059\u308b\u3053\u3068\u3092\u5f37\u304f\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u7814\u7a76\u8005\u306f\u3001\u4ed6\u306e\u7814\u7a76\u8005\u306b\u3088\u308b\u89b3\u5bdf\u7814\u7a76\u306e\u30c7\u30b6\u30a4\u30f3\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001\u53ce\u96c6\u3055\u308c\u305f\u307e\u305f\u306f\u53ce\u96c6\u3055\u308c\u308b\u4e88\u5b9a\u306e\u30c7\u30fc\u30bf\u306e\u8aac\u660e\u3068\u3068\u3082\u306b\u3001\u7814\u7a76\u8a08\u753b\u66f8\u3092\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3057\u3066\u516c\u958b\u3059\u308b\u3053\u3068\u304c\u5968\u52b1\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u63a8\u5968\u6cbb\u7642\u3068\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong><\/h3>\n<p>\u6b27\u5dde\u59d4\u54e1\u4f1a\uff08EC\uff09\u304c\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u521d\u671f\u306b\u8ff0\u3079\u305f\u3088\u3046\u306b\u3001\u300c&#8230;COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u9032\u5316\u306f\u3001\u6642\u671f\u306b\u3088\u3063\u3066\u91cd\u75c7\u5ea6\u304c\u7570\u306a\u308b\u56fd\u3005\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002\u60a3\u8005\u306e\u7ba1\u7406\u65b9\u6cd5\u3001\u7279\u306b\u91cd\u75c7\u60a3\u8005\u306e\u7ba1\u7406\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u5b9f\u8df5\u7684\u306a\u7d4c\u9a13\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u306f\u4e4f\u3057\u304f\u3001\u6563\u5728\u3057\u3066\u3044\u308b\u3002\u4e00\u90e8\u306e\u75c5\u9662\u3067\u306f\u7d4c\u9a13\u3068\u75c7\u4f8b\u6570\u304c\u91cd\u8981\u3067\u3042\u308b\u304c\u3001\u4ed6\u306e\u75c5\u9662\u3067\u306f\u8907\u96d1\u306a\u60a3\u8005\u3078\u306e\u5bfe\u5fdc\u3092\u59cb\u3081\u305f\u3070\u304b\u308a\u3067\u3042\u308b\u3002\u300d<\/p>\n<p>COVID-19\u60a3\u8005\u306e\u6cbb\u7642\u306b\u95a2\u3059\u308b\u77e5\u898b\u306b\u95a2\u3059\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u3001EC\u306f<a href=\"https:\/\/ec.europa.eu\/newsroom\/sante\/newsletter-specific-archive-issue.cfm?archtype=specific&amp;newsletter_service_id=327&amp;newsletter_issue_id=21060&amp;page=1&amp;fullDate=Fri%2027%20Mar%202020&amp;lang=default\" target=\"_blank\" rel=\"noopener\">COVID-19\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u30b7\u30b9\u30c6\u30e0\uff08CMSS\uff09\u3092\u8fc5\u901f\u306b\u7acb\u3061\u4e0a\u3052<\/a>\u3001EU\u3001\u82f1\u56fd\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u8af8\u56fd\u306eCOVID-19\u75c7\u4f8b\u3092\u6271\u3046\u75c5\u9662\u306e\u533b\u7642\u5f93\u4e8b\u8005\u9593\u306e\u8fc5\u901f\u306a\u9023\u643a\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002<a href=\"https:\/\/ec.europa.eu\/health\/ern\/covid-19_en\" target=\"_blank\" rel=\"noopener\">\u3053\u306e\u5354\u529b<\/a>\u306f\u3001\u7279\u5b9a\u306e\u6cbb\u7642\u30aa\u30d7\u30b7\u30e7\u30f3\u306e\u63a1\u7528\u3092\u8fc5\u901f\u5316\u3057\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u6539\u5584\u3057\u3001\u30a6\u30a4\u30eb\u30b9\u306b\u95a2\u3059\u308b\u4e0d\u78ba\u5b9f\u6027\u306e\u4e00\u90e8\u3092\u8efd\u6e1b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001EC\u306f\u56fd\u5883\u3092\u8d8a\u3048\u305f\u533b\u7642\u5354\u529b\u306e\u305f\u3081\u306e<a href=\"https:\/\/ec.europa.eu\/info\/sites\/info\/files\/guidelines_on_eu_emergency_assistance_in_cross-bordercooperationin_heathcare_related_to_the_covid-19_crisis.pdf\" target=\"_blank\" rel=\"noopener\">\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>\u3092\u63a1\u629e\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u7c73\u56fd\u3067\u306f\u3001NIH\u304c\u533b\u5e2b\u3084\u7d71\u8a08\u5b66\u8005\u306a\u3069\u306e\u5c02\u9580\u5bb6\u306b\u3088\u308b\u533b\u7642\u5f93\u4e8b\u8005\u5411\u3051\u306e<a href=\"https:\/\/www.nih.gov\/news-events\/news-releases\/expert-us-panel-develops-nih-treatment-guidelines-covid-19\" target=\"_blank\" rel=\"noopener\">\u6cbb\u7642\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306f\u3001\u516c\u8868\u3055\u308c\u305f\u30c7\u30fc\u30bf\u3084\u4e88\u5099\u7684\u306a\u30c7\u30fc\u30bf\u3001\u30d1\u30cd\u30e9\u30fc\u306e\u81e8\u5e8a\u7684\u5c02\u9580\u77e5\u8b58\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001\u65b0\u305f\u306a\u60c5\u5831\u304c\u767a\u8868\u3055\u308c\u305f\u969b\u306b\u306f<a href=\"https:\/\/www.covid19treatmentguidelines.nih.gov\/whats-new\/\" target=\"_blank\" rel=\"noopener\">\u66f4\u65b0<\/a>\u3059\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001\u898f\u5236\u5f53\u5c40\u306f\u3001COVID-19\u304c\u78ba\u8a8d\u3055\u308c\u305f\u60a3\u8005\u3084\u305d\u306e\u7591\u3044\u306e\u3042\u308b\u60a3\u8005\u306b\u5bfe\u3057\u3066\u306f\u3001\u76ee\u7684\u3092\u554f\u308f\u305a\u3001\u9069\u5fdc\u5916\u30fb\u9069\u5fdc\u5916\u3092\u554f\u308f\u305a\u3001\u3059\u3079\u3066\u306e\u85ac\u5264\u306e\u526f\u4f5c\u7528\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3057\u3001<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/reporting-suspected-side-effects-medicines-patients-covid-19\" target=\"_blank\" rel=\"noopener\">\u5831\u544a<\/a>\u3092\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u30ec\u30e0\u30c7\u30b7\u30d3\u30eb\u3068\u30af\u30ed\u30ed\u30ad\u30f3\u30ea\u30f3\u9178\u5869\u307e\u305f\u306f\u30d2\u30c9\u30ed\u30ad\u30b7\u30af\u30ed\u30ed\u30ad\u30f3\u786b\u9178\u5869\u3068\u306e\u4f75\u7528\u6295\u4e0e\u306b\u3088\u308a\u3001\u30ec\u30e0\u30c7\u30b7\u30d3\u30eb\u306e\u6297\u30a6\u30a4\u30eb\u30b9\u6d3b\u6027\u304c\u4f4e\u4e0b\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u304c\u5224\u660e\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u30a2\u30f3\u30ae\u30aa\u30c6\u30f3\u30b7\u30f3\u5909\u63db\u9175\u7d20\uff08ACE\uff09\u963b\u5bb3\u5264\u3084\u30a2\u30f3\u30ae\u30aa\u30c6\u30f3\u30b7\u30f3\u53d7\u5bb9\u4f53\u62ee\u6297\u5264\uff08ARB\uff09\u3001\u3042\u308b\u3044\u306f\u30a4\u30d6\u30d7\u30ed\u30d5\u30a7\u30f3\u306a\u3069\u306e\u975e\u30b9\u30c6\u30ed\u30a4\u30c9\u6027\u6297\u708e\u75c7\u85ac\uff08NSAIDs\uff09\u304c\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u75be\u60a3\u3092\u60aa\u5316\u3055\u305b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u7591\u554f\u8996\u3057\u305f\u51fa\u7248\u7269\u306b\u57fa\u3065\u304d\u3001EMA\u306f\u72b6\u6cc1\u3092\u6ce8\u8996\u3057\u3001<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/latest-data-support-continued-use-ace-inhibitors-arb-medicines-during-covid-19-pandemic\" target=\"_blank\" rel=\"noopener\">ACE\u963b\u5bb3\u5264\/ARBs<\/a>\u3082<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-gives-advice-use-non-steroidal-anti-inflammatories-covid-19\" target=\"_blank\" rel=\"noopener\">NSAIDs<\/a>\u3082COVID-19\u611f\u67d3\u306e\u30ea\u30b9\u30af\u3084COVID-19\u75be\u60a3\u60a3\u8005\u306e\u8ee2\u5e30\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3088\u3046\u306b\u306f\u898b\u3048\u306a\u3044\u3068\u5224\u65ad\u3057\u307e\u3057\u305f\u3002FDA\u306f\u3001COVID-19\u6cbb\u7642\u306b\u304a\u3051\u308b\u56de\u5fa9\u671f\u8840\u6f3f\u306e\u6f5c\u5728\u7684\u306a\u6709\u52b9\u6027\u306b\u57fa\u3065\u304d\u3001EUA\u306e\u4e0b\u3067\u306e\u4f7f\u7528\u3068\u6cbb\u9a13\u85ac\u3068\u3057\u3066\u306e\u4f7f\u7528\u306e\u4e21\u65b9\u306b\u3064\u3044\u3066<a href=\"https:\/\/www.fda.gov\/media\/136798\/download\" target=\"_blank\" rel=\"noopener\">\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a>\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u76ee\u306b\u898b\u3048\u308b\u6210\u679c<\/strong><\/h3>\n<p>\u52b9\u679c\u7684\u306a\u6cbb\u7642\u306b\u3088\u308a\u3001\u75c7\u4f8b\u6570\u304c\u518d\u3073\u5897\u52a0\u3057\u3066\u3082COVID-19\u306e\u6b7b\u4ea1\u7387\u306e\u6e1b\u5c11\u304c\u89b3\u5bdf\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u611f\u67d3\u62e1\u5927\u3092\u6e1b\u5c11\u3055\u305b\u308b\u305f\u3081\u306e\u52aa\u529b\u3001\u691c\u67fb\u306b\u3088\u308b\u75ab\u5b66\u7684\u30c7\u30fc\u30bf\u3001\u63a5\u89e6\u8005\u8ffd\u8de1\u306f\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u6b21\u56de\u3067\u306f\u3001\u611f\u67d3\u304c\u3069\u3053\u3067\u3069\u306e\u3088\u3046\u306b\u767a\u751f\u3057\u3066\u3044\u308b\u304b\u3092\u8ffd\u8de1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u305f\u3081\u3001\u898f\u5236\u5f53\u5c40\u304c\u3069\u306e\u3088\u3046\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u308b\u304b\u306b\u3064\u3044\u3066\u3054\u7d39\u4ecb\u3057\u307e\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\u63d0\u51fa\u306e\u6642\u9593\u3092\u7bc0\u7d04\u3059\u308b\u305f\u3081\u306b\u306f<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/chemistry-manufacturing-controls-intelligence-analysis\/\">clarivate.com\/cortelliscmc<\/a> \u306b\u30a2\u30af\u30bb\u30b9\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; &nbsp; COVID-19 \u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u7d42\u606f\u306b\u5411\u3051\u305f\u53d6\u308a\u7d44\u307f\u306f\u591a\u9762\u7684\u306b\u884c\u308f\u308c\u3066\u304a\u308a\u3001\u75ab\u5b66\u7684\u30c7\u30fc\u30bf\u306e\u628a\u63e1\u3001\u4e88\u9632\u306e\u305f\u3081\u306e\u30ef\u30af\u30c1\u30f3\u3084\u975e\u533b\u85ac\u54c1\u306b\u3088\u308b\u4ecb\u5165\u3001\u6cbb\u7642\u306e\u305f\u3081\u306e\u65b0\u85ac\u3084\u518d\u5229\u7528\u85ac\u306e\u958b\u767a\u306a\u3069\u3001\u591a\u5c90\u306b\u308f\u305f\u3063\u3066\u3044\u307e\u3059\u3002 \u4eca\u56de\u306e\u30d6\u30ed\u30b0\u8a18\u4e8b\u3067\u306f\u3001Cortellis Regulatory Intelligence\u2122\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306eMonia Tumminello\u3068Cortellis Regulatory Intelligence\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306eJaime Polychrones\u304c\u3001\u65b0\u305f\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u767a\u884c\u304b\u3089\u65e9\u671f\u627f\u8a8d\u3001\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u306b\u81f3\u308b\u307e\u3067\u3001\u6cbb\u7642\u85ac\u958b\u767a\u306b\u304a\u3051\u308b\u898f\u5236\u5f53\u5c40\u306e\u5bfe\u5fdc\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u307e\u3059\u3002 &nbsp; &nbsp; COVID-19 \u30ef\u30af\u30c1\u30f3\u306e\u958b\u767a\u3068\u6295\u4e0e\u306f\u3001\u8fc5\u901f\u306a\u627f\u8a8d\u53d6\u5f97\u3068\u88fd\u9020\u30fb\u8ca9\u58f2\u3078\u306e\u6295\u8cc7\u306e\u9023\u643a\u306b\u3088\u308a\u3001\u6025\u901f\u306b\u9032\u5c55\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u5f93\u4e8b\u8005\u304cCOVID-19\u3067\u60a3\u8005\u3055\u3093\u3092\u30b1\u30a2\u3059\u308b\u4e2d\u3067\u3001\u6cbb\u7642\u6cd5\u306e\u7814\u7a76\uff08\u516c\u5f0f\u30fb\u975e\u516c\u5f0f\u3092\u554f\u308f\u305a\uff09\u306e\u30b9\u30d4\u30fc\u30c9\u3082\u3053\u308c\u307e\u3067\u306b\u306a\u3044\u3082\u306e\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002 \u3053\u308c\u3089\u306e\u533b\u85ac\u54c1\u306e\u958b\u767a\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3084\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u304c\u30ef\u30af\u30c1\u30f3\u958b\u767a\u306e\u305f\u3081\u306b\u63d0\u4f9b\u3057\u3066\u3044\u308b\u652f\u63f4\u7b56\u306e\u591a\u304f\u3082\u3001\u7121\u6599\u306e\u79d1\u5b66\u7684\u30a2\u30c9\u30d0\u30a4\u30b9\u3001\u52a0\u901f\u8a55\u4fa1\u3001\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u627f\u8a8d\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u65bd\u7b56\u3068\u3001\u305d\u306e\u767a\u5c55\u304c\u3069\u306e\u3088\u3046\u306b\u6cbb\u7642\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u767a\u5c55\u3057\u3066\u304d\u305f\u306e\u304b\u3092\u8aac\u660e\u3057\u307e\u3059\u3002 &nbsp; &nbsp; \u65b0\u305f\u306a\u898f\u5236\u4e0a\u306e\u30ac\u30a4\u30c0\u30f3\u30b9 \u65e9\u304f\u30822020\u5e745\u6708\u306b\u306f\u3001FDA\u306f\u3001\u65b0\u85ac\u3084\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u8a66\u9a13\u958b\u59cb\u306e\u305f\u3081\u306e\u7533\u8acb\u66f8\u306e\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u3092\u3088\u308a\u52b9\u7387\u7684\u306b\u3059\u308b\u305f\u3081\u306e\u7814\u7a76\u8005\u5411\u3051\u306e\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u65b0\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306e\u63a8\u5968\u4e8b\u9805\u3082\u6982\u8aac\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u300cCOVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational&#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-1691","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-cortellis"],"acf":[],"lang":"ja","translations":{"ja":1691},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1691","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=1691"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1691\/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=1691"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1691"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1691"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}