{"id":3298,"date":"2021-08-20T15:03:44","date_gmt":"2021-08-20T06:03:44","guid":{"rendered":"https:\/\/clarivate.com\/ja\/?p=3298"},"modified":"2021-08-20T15:03:44","modified_gmt":"2021-08-20T06:03:44","slug":"three-key-trends-in-regulatory-approvals-of-new-medicines-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/three-key-trends-in-regulatory-approvals-of-new-medicines-2\/","title":{"rendered":"\u65b0\u85ac\u306e\u85ac\u4e8b\u627f\u8a8d\u306b\u304a\u3051\u308b3\u3064\u306e\u91cd\u8981\u306a\u30c8\u30ec\u30f3\u30c9"},"content":{"rendered":"<p><a href=\"https:\/\/clarivate.com\/blog\/three-key-trends-in-regulatory-approvals-of-new-medicines\/\">\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><strong>DR. JENNY SHARPE<\/strong><br \/>\nSenior Scientific Writer, Centre for Innovation in Regulatory Science, Clarivate<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/cirsci.org\/\" target=\"_blank\" rel=\"noopener\">Centre for Innovation in Regulatory Science\uff08CIRS\uff09<\/a>\u306e<a href=\"https:\/\/cirsci.org\/publications\/cirs-rd-briefing-81-new-drug-approvals-in-six-major-authorities-2011-2020\/\" target=\"_blank\" rel=\"noopener\">\u65b0\u3057\u3044\u7814\u7a76<\/a>\u306b\u3088\u308b\u3068\u3001\u904e\u53bb20\u5e74\u9593\u306e\u898f\u5236\u306e\u53ce\u675f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4e16\u754c\u306e\u898f\u5236\u5f53\u5c40\u9593\u3067\u627f\u8a8d\u307e\u3067\u306e\u6642\u9593\u306b\u4f9d\u7136\u3068\u3057\u3066\u5dee\u304c\u3042\u308b\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u4ee5\u4e0b\u306e\u8a18\u4e8b\u306f\u3001\u6700\u65b0\u306eCIRS R&amp;D\u30d6\u30ea\u30fc\u30d5\u30a3\u30f3\u30b0 \u300c<a href=\"https:\/\/cirsci.org\/publications\/cirs-rd-briefing-81-new-drug-approvals-in-six-major-authorities-2011-2020\/\" target=\"_blank\" rel=\"noopener\">New Drug approvals in six major authorities 2011-2020<\/a>\u300d\u304b\u3089\u5f97\u3089\u308c\u305f\u4e3b\u8981\u306a\u77e5\u898b\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3001\u65e5\u672c\u306e\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u3001\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u3001\u30b9\u30a4\u30b9\u533b\u85ac\u54c1\u5c40\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u6cbb\u7642\u85ac\u5c40\uff08TGA\uff09\u306e\u5be9\u67fb\u627f\u8a8d\u6642\u9593\u3092\u5206\u6790\u3057\u305f\u7d50\u679c\u30013\u3064\u306e\u5927\u304d\u306a\u50be\u5411\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>1. \u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u306b\u8981\u3059\u308b\u6642\u9593\u306f\u307e\u3060\u7570\u306a\u308b<\/strong><\/h3>\n<p>\u904e\u53bb20\u5e74\u9593\u306e\u898f\u5236\u306e\u53ce\u675f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u672c\u7814\u7a76\u3067\u306f\u30012020\u5e74\u306b\u306f6\u6a5f\u95a2\u306e\u9593\u3067\u627f\u8a8d\u6642\u9593\u306b\u307e\u3060\u5dee\u304c\u3042\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u307e\u3057\u305f\uff08\u56f31\uff09\u3002\u3053\u306e\u5dee\u306f\u3001\u4ed6\u306e4\u6a5f\u95a2\u306b\u6bd4\u3079\u3066\u6b27\u5dde\u306e\u898f\u5236\u5f53\u5c40\uff08EMA\u304a\u3088\u3073\u30b9\u30a4\u30b9\u533b\u85ac\u54c1\u5c40\uff09\u3067\u7279\u306b\u9855\u8457\u3067\u3057\u305f\u3002<\/p>\n<p>\u3057\u304b\u3057\u3001\u7533\u8acb\u304b\u3089\u79d1\u5b66\u7684\u8a55\u4fa1\u306e\u7d42\u4e86\u307e\u3067\u306e\u671f\u9593\u3092\u6bd4\u8f03\u3059\u308b\u3068\u30016\u6a5f\u95a2\u9593\u3067\u306e\u3070\u3089\u3064\u304d\u306f\u5927\u304d\u304f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\uff08\u56f31\u306e\u30ab\u30c3\u30b3\u5185\u306e\u6570\u5b57\uff09\u3002\u3053\u306e\u3053\u3068\u304b\u3089\u3001\u5c11\u306a\u304f\u3068\u3082\u4e00\u90e8\u306e\u6a5f\u95a2\u3067\u306f\u3001\u79d1\u5b66\u7684\u8a55\u4fa1\u306e\u7d42\u4e86\u5f8c\u306b\u3001\u4e8b\u52d9\u7684\u306a\u6d3b\u52d5\u3084\u30b9\u30dd\u30f3\u30b5\u30fc\u3068\u306e\u8ffd\u52a0\u7684\u306a\u8868\u793a\u306e\u4ea4\u6e09\u306a\u3069\u306e\u6d3b\u52d5\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p><span style=\"font-size: small\"><strong>\u56f31\uff1a2011\u5e74\uff5e2020\u5e74\u306b\u304a\u3051\u308b6\u3064\u306e\u898f\u5236\u5f53\u5c40\u306e\u65b0\u6709\u52b9\u6210\u5206\uff08NAS\uff09\u306e\u627f\u8a8d\u671f\u9593\u306e\u4e2d\u592e\u5024<\/strong><\/span><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-3300\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRS_image1.jpg\" alt=\"\" width=\"989\" height=\"507\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRS_image1.jpg 989w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRS_image1-300x154.jpg 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRS_image1-768x394.jpg 768w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRS_image1-78x40.jpg 78w\" sizes=\"auto, (max-width: 989px) 100vw, 989px\" \/><\/p>\n<p><span style=\"font-size: small\">\u51fa\u5178\uff1aCentre for Innovation in Regulatory Science Centre for Innovation in Regulatory Science (CIRS)<\/span><\/p>\n<p><span style=\"font-size: small\"><em>\u627f\u8a8d\u6642\u9593\u306f\u3001\u7533\u8acb\u65e5\u304b\u3089\u5f53\u5c40\u306b\u3088\u308b\u627f\u8a8d\u65e5\u307e\u3067\u3067\u8a08\u7b97\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u6642\u9593\u306b\u306f\u3001\u6a5f\u95a2\u3068\u4f01\u696d\u306e\u6642\u9593\u304c\u542b\u307e\u308c\u307e\u3059\u3002EMA\u306e\u627f\u8a8d\u6642\u9593\u306b\u306f\u3001EU\u59d4\u54e1\u4f1a\u306e\u6642\u9593\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002N1\uff1d2020\u5e74\u306b\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u306e\u627f\u8a8d\u6642\u9593\u306e\u4e2d\u592e\u5024\u3001\uff08N2\uff09\uff1d2020\u5e74\u306b\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u306e\u63d0\u51fa\u304b\u3089\u79d1\u5b66\u7684\u8a55\u4fa1\u306e\u7d42\u4e86\u307e\u3067\u306e\u6642\u9593\u306e\u4e2d\u592e\u5024\u3002<\/em><\/span><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>2. FDA\u306f\u6700\u3082\u591a\u304f\u306eNAS\u3092\u627f\u8a8d\u3057\u7d9a\u3051\u3066\u3044\u308b<\/strong><\/h3>\n<p>\u4eca\u56de\u306e\u8abf\u67fb\u3067\u306f\u30016\u6a5f\u95a2\u304c\u627f\u8a8d\u3057\u305fNAS\u306e\u6570\u306f\u3001\u904e\u53bb10\u5e74\u9593\u3067\u304a\u304a\u3080\u306d\u5897\u52a0\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u904e\u53bb5\u5e74\u9593\u306e\u307f\u3092\u8003\u616e\u3057\u305f\u5834\u5408\u3001FDA\u3092\u9664\u304f\u3059\u3079\u3066\u306e\u6a5f\u95a2\u3067\u627f\u8a8d\u6570\u306b\u30d7\u30e9\u30c8\u30fc\u304c\u898b\u3089\u308c\u3001\u5f15\u304d\u7d9a\u304d\u627f\u8a8d\u6570\u304c\u5897\u52a0\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u3001FDA\u3067\u4fc3\u9032\u3055\u308c\u305f\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30d1\u30b9\u30a6\u30a7\u30a4\u304c\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u3053\u3068\u3084\u3001FDA\u3067\u627f\u8a8d\u3055\u308c\u305f\u533b\u85ac\u54c1\u3001\u7279\u306b\u4e2d\u5c0f\u4f01\u696d\u306e\u533b\u85ac\u54c1\u304c\u56fd\u969b\u5316\u3055\u308c\u306a\u3044\u3053\u3068\u304c\u539f\u56e0\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>3. \u4f5c\u696d\u5206\u62c5\u306e\u91cd\u8981\u6027\u306e\u9ad8\u307e\u308a<\/strong><\/h3>\n<p>\u3044\u304f\u3064\u304b\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u898f\u5236\u8a55\u4fa1\u306e\u91cd\u8907\u3092\u907f\u3051\u3001\u8cc7\u6e90\u306e\u52b9\u7387\u7684\u306a\u5229\u7528\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b\u3001\u4f5c\u696d\u5206\u62c5\u306e\u305f\u3081\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3092\u958b\u767a\u3057\u3066\u3044\u308b\u304b\u3001\u958b\u767a\u4e2d\u3067\u3059\u3002\u30ef\u30fc\u30af\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u95a2\u4fc2\u6a5f\u95a2\u306f\u63d0\u51fa\u3055\u308c\u305f\u66f8\u985e\u306e\u3055\u307e\u3056\u307e\u306a\u90e8\u5206\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3066\u3044\u307e\u3059\u3002\u5be9\u67fb\u306f\u5171\u6709\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u65b0\u85ac\u306e\u627f\u8a8d\u306b\u95a2\u3057\u3066\u306f\u5404\u898f\u5236\u5f53\u5c40\u304c\u72ec\u7acb\u3057\u3066\u5224\u65ad\u3057\u307e\u3059\u3002<\/p>\n<p>\u4eca\u56de\u306eCIRS\u306e\u8abf\u67fb\u3067\u306f\u30016\u3064\u306e\u6a5f\u95a2\u306e\u4e00\u90e8\u3092\u5bfe\u8c61\u3068\u3057\u305f2\u3064\u306e\u30ef\u30fc\u30af\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u306e\u53d6\u308a\u7d44\u307f\u3001<a href=\"https:\/\/www.tga.gov.au\/australia-canada-singapore-switzerland-united-kingdom-access-consortium\" target=\"_blank\" rel=\"noopener\">Access Consortium<\/a>\u3068<a href=\"https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/project-orbis\" target=\"_blank\" rel=\"noopener\">Project Orbis<\/a>\u306e\u7d50\u679c\u3092\u8a73\u3057\u304f\u898b\u3066\u307f\u307e\u3057\u305f\u30022018\u5e74\u304b\u30892020\u5e74\u306e\u9593\u306b\u30017\u3064\u306eNAS\u304c\u30a2\u30af\u30bb\u30b9\u30b3\u30f3\u30bd\u30fc\u30b7\u30a2\u30e0\u306b\u53c2\u52a0\u3057\u3066\u3044\u308b\u6a5f\u95a2\u306e1\u3064\u4ee5\u4e0a\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u30022019\u5e74\u306e\u958b\u59cb\u4ee5\u6765\u3001Project Orbis\u306f3\u3064\u306eNAS\u306e\u627f\u8a8d\u3092\u4fc3\u9032\u3057\u307e\u3057\u305f\uff08\u56f32\uff09\u3002\u8208\u5473\u6df1\u3044\u3053\u3068\u306b\u3001NAS\u306f\u30aa\u30fc\u30d5\u30a1\u30f3\u6307\u5b9a\u3060\u3051\u3067\u306a\u304f\u3001\u5b9f\u65bd\u3055\u308c\u305f\u5be9\u67fb\u306e\u7a2e\u985e\uff08\u8fc5\u901f\u5be9\u67fb\u3068\u6a19\u6e96\u5be9\u67fb\uff09\u3082\u7570\u306a\u3063\u3066\u304a\u308a\u3001\u3053\u308c\u306f\u8fc5\u901f\u5be9\u67fb\u3084\u30aa\u30fc\u30d5\u30a1\u30f3\u6307\u5b9a\u3092\u53d7\u3051\u308b\u305f\u3081\u306e\u6a5f\u95a2\u306e\u57fa\u6e96\u3001\u5229\u7528\u53ef\u80fd\u306a\u30d7\u30ed\u30bb\u30b9\uff08\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u306f\u73fe\u5728\u30aa\u30fc\u30d5\u30a1\u30f3\u30dd\u30ea\u30b7\u30fc\u3092\u6301\u3063\u3066\u3044\u306a\u3044\uff09\u3001\u30d1\u30b9\u30a6\u30a7\u30a4\u3084\u6307\u5b9a\u3092\u7533\u8acb\u3059\u308b\u305f\u3081\u306e\u4f01\u696d\u6226\u7565\u306e\u9055\u3044\u3092\u6d6e\u304d\u5f6b\u308a\u306b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-size: small\"><strong>\u56f32\uff1a2020\u5e74\u306bProject Orbis\u306e\u30e1\u30f3\u30d0\u30fc\u304c\u627f\u8a8d\u3057\u305fNAS\u306e\u7533\u8acb\u30e9\u30b0\u3068\u627f\u8a8d\u307e\u3067\u306e\u6642\u9593<\/strong><\/span><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-3301\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRSimage2.png\" alt=\"\" width=\"940\" height=\"464\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRSimage2.png 940w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRSimage2-300x148.png 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRSimage2-768x379.png 768w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2021\/08\/CIRSimage2-81x40.png 81w\" sizes=\"auto, (max-width: 940px) 100vw, 940px\" \/><\/p>\n<p><span style=\"font-size: small\">\u51fa\u5178: Centre for Innovation in Regulatory Science (CIRS)<\/span><\/p>\n<p><span style=\"font-size: small\"><em>\u7533\u8acb\u30e9\u30b0\u306f\u3001\u6700\u521d\u306e\u898f\u5236\u6a5f\u95a2\u3067\u306e\u7533\u8acb\u65e5\u304b\u3089\u5bfe\u8c61\u6a5f\u95a2\u3078\u306e\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u65e5\u307e\u3067\u306e\u6642\u9593\u3068\u3057\u3066\u8a08\u7b97\u3055\u308c\u307e\u3059\u3002\u300c\u8fc5\u901f\u5be9\u67fb\u300d\u3068\u306f\u3001\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\/TGA\u306e\u300c\u512a\u5148\u5be9\u67fb\u300d\u3068\u30b9\u30a4\u30b9\u533b\u85ac\u54c1\u5c40\u306e\u300c\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u300d\u3092\u6307\u3057\u307e\u3059\u3002\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u306f\u73fe\u5728\u3001\u30aa\u30fc\u30d5\u30a1\u30f3\u30dd\u30ea\u30b7\u30fc\u3092\u8a2d\u3051\u3066\u3044\u307e\u305b\u3093\u3002\u627f\u8a8d\u307e\u3067\u306e\u671f\u9593\u306f\u3001\u7533\u8acb\u65e5\u304b\u3089\u5bfe\u8c61\u6a5f\u95a2\u306e\u627f\u8a8d\u65e5\u307e\u3067\u3067\u8a08\u7b97\u3057\u3066\u3044\u307e\u3059\u3002<\/em><\/span><\/p>\n<p>&nbsp;<\/p>\n<h3><strong>COVID-19\u306e\u5f71\u97ff<\/strong><\/h3>\n<p>&nbsp;<\/p>\n<p>COVID-19\u306e\u3088\u3046\u306a\u30a2\u30f3\u30e1\u30c3\u30c8\u30cb\u30fc\u30ba\u306e\u3042\u308b\u9818\u57df\u3084\u305d\u306e\u4ed6\u306e\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u8fc5\u901f\u306a\u898f\u5236\u7d4c\u8def\u3084\u305d\u306e\u4ed6\u306e\u4fc3\u9032\u3055\u308c\u305f\u898f\u5236\u7d4c\u8def\u3092\u5229\u7528\u30fb\u6d3b\u7528\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\uff08\u8a73\u7d30\u306f<a href=\"https:\/\/cirsci.org\/publications\/cirs-rd-briefing-75-emergency-use-pathways-eups\/\" target=\"_blank\" rel=\"noopener\">CIRS R&amp;D Briefing 75<\/a>\u3092\u53c2\u7167\uff09\u30022020\u5e74\u3001COVID-19\u6cbb\u7642\u85ac\u306e\u30ec\u30e0\u30c7\u30b7\u30d3\u30eb\u306f\u30016\u3064\u306e\u5168\u6a5f\u95a2\u3067\u6700\u3082\u65e9\u304f\u627f\u8a8d\u3055\u308c\u305f\u6297\u611f\u67d3\u75c7\u85ac\u306e\u4e00\u3064\u3067\u3042\u308a\u3001\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u3001FDA\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u3001\u30ed\u30fc\u30ea\u30f3\u30b0\u30ec\u30d3\u30e5\u30fc\u306e\u5229\u7528\u306a\u3069\u3001\u69d8\u3005\u306a\u8fc5\u901f\u5316\u30fb\u4fc3\u9032\u5316\u3055\u308c\u305f\u898f\u5236\u7d4c\u8def\u304c\u5229\u7528\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u65b0\u305f\u306a\u53d6\u308a\u7d44\u307f\u65b9\u6cd5\u304c\u6a21\u7d22\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001COVID-19\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u3068\u898f\u5236\u5f53\u5c40\u306e\u53cc\u65b9\u306b\u5927\u304d\u306a\u30d7\u30ec\u30c3\u30b7\u30e3\u30fc\u3092\u4e0e\u3048\u7d9a\u3051\u3066\u3044\u307e\u3059\uff08\u8a73\u7d30\u306f<a href=\"https:\/\/cirsci.org\/publications\/cirs-rd-briefing-80-reimagining-medicine-regulatory-models\/\" target=\"_blank\" rel=\"noopener\">CIRS R&amp;D Briefing 80<\/a>\u3092\u53c2\u7167\uff09\u3002\u4eca\u5f8c\u6570\u5e74\u9593\u306eCIRS\u306e\u5206\u6790\u3067\u306f\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u304c6\u3064\u306e\u898f\u5236\u6a5f\u95a2\u306b\u3088\u308bNAS\u306e\u627f\u8a8d\u306b\u4e0e\u3048\u305f\u5f71\u97ff\u3001\u4f8b\u3048\u3070\u627f\u8a8d\u6642\u9593\u306e\u5897\u52a0\u3084\u533b\u85ac\u54c1\u306e\u56fd\u969b\u5316\u306e\u6e1b\u5c11\u306a\u3069\u304c\u660e\u3089\u304b\u306b\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002<\/p>\n<p><a href=\"https:\/\/cirsci.org\/\" target=\"_blank\" rel=\"noopener\">CIRS<\/a>\u3067\u306f\u30012002\u5e74\u304b\u3089\u898f\u5236\u5f53\u5c40\u306e\u30d9\u30f3\u30c1\u30de\u30fc\u30ad\u30f3\u30b0\u3092\u884c\u3063\u3066\u304a\u308a\u3001\u540c\u7a2e\u306e\u6bd4\u8f03\u304c\u3067\u304d\u308b\u3088\u3046\u306b\u898f\u5236\u5f53\u5c40\u3068\u5171\u540c\u3067\u958b\u767a\u3057\u305f\u624b\u6cd5\u3092\u7528\u3044\u3066\u3044\u307e\u3059\u30022012\u5e74\u304b\u3089\u6bce\u5e74\u767a\u8868\u3055\u308c\u3066\u3044\u308b\u5206\u6790\u7d50\u679c\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u30d7\u30ed\u30bb\u30b9\u3084\u5b9f\u52d9\u306b\u3064\u3044\u3066\u72ec\u81ea\u306e\u6d1e\u5bdf\u3092\u4e0e\u3048\u3001\u6539\u5584\u3059\u3079\u304d\u70b9\u3092\u7279\u5b9a\u3057\u3001\u4f01\u696d\u3084\u898f\u5236\u5f53\u5c40\u306e\u6226\u7565\u306b\u5f79\u7acb\u3066\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u898f\u5236\u306b\u95a2\u3059\u308b\u3088\u308a\u8a73\u3057\u3044\u60c5\u5831\u306f\u3001\u30d6\u30ea\u30fc\u30d5\u30a3\u30f3\u30b0\u300c<a href=\"https:\/\/cirsci.org\/publications\/cirs-rd-briefing-81-new-drug-approvals-in-six-major-authorities-2011-2020\/\" target=\"_blank\" rel=\"noopener\">New drug approvals in six major authorities 2011-2020<\/a>\u300d\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/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; DR. JENNY SHARPE Senior Scientific Writer, Centre for Innovation in Regulatory Science, Clarivate &nbsp; Centre for Innovation in Regulatory Science\uff08CIRS\uff09\u306e\u65b0\u3057\u3044\u7814\u7a76\u306b\u3088\u308b\u3068\u3001\u904e\u53bb20\u5e74\u9593\u306e\u898f\u5236\u306e\u53ce\u675f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4e16\u754c\u306e\u898f\u5236\u5f53\u5c40\u9593\u3067\u627f\u8a8d\u307e\u3067\u306e\u6642\u9593\u306b\u4f9d\u7136\u3068\u3057\u3066\u5dee\u304c\u3042\u308b\u3053\u3068\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u4ee5\u4e0b\u306e\u8a18\u4e8b\u306f\u3001\u6700\u65b0\u306eCIRS R&amp;D\u30d6\u30ea\u30fc\u30d5\u30a3\u30f3\u30b0 \u300cNew Drug approvals in six major&#8230;<\/p>\n","protected":false},"author":161,"featured_media":3302,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1309,1297,1300,1228],"tags":[],"class_list":["post-3298","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","category-blog","category-cortellis","category-life-sciences-healthcare","clarivate-industry-life-sciences-and-healthcare","clarivate-product-biopharma"],"acf":[],"lang":"ja","translations":{"ja":3298},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/3298","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=3298"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/3298\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/3302"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=3298"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=3298"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=3298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}