{"id":1737,"date":"2020-07-21T08:58:59","date_gmt":"2020-07-20T23:58:59","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/2019%e5%b9%b4%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e6%96%b0%e8%96%ac%e3%81%ae%e6%89%bf%e8%aa%8d%e5%82%be%e5%90%91%e3%82%92%e5%88%86%e6%9e%90\/?lang=ja"},"modified":"2020-07-21T08:58:59","modified_gmt":"2020-07-20T23:58:59","slug":"2019-trends-in-regulatory-approvals-of-new-medicines-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/2019-trends-in-regulatory-approvals-of-new-medicines-2\/","title":{"rendered":"2019\u5e74\u306b\u304a\u3051\u308b\u65b0\u85ac\u306e\u627f\u8a8d\u50be\u5411\u3092\u5206\u6790"},"content":{"rendered":"
\"Jenny<\/span><\/div>\n
\n

JENNY SHARPE<\/p>\n

Senior Scientific Writer, CIRS<\/p>\n

Clarivate<\/p>\n<\/div>\n

 
\n 
\n 
\n 
\n\u82f1\u8a9e\u539f\u6587<\/a><\/p>\n

 <\/p>\n

Centre for Innovation in Regulatory Science\uff08CIRS\uff09\u306e\u7814\u7a76\u3067\u306f\u30016\u3064\u306e\u4e3b\u8981\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u65b0\u898f\u6d3b\u6027\u7269\u8cea\uff08NAS\uff09\u306e\u627f\u8a8d\u50be\u5411\u304c\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f1<\/sup> \u3002\u672c\u8abf\u67fb\u3067\u306f\u3001\u627f\u8a8d\u4ef6\u6570\u3084\u627f\u8a8d\u307e\u3067\u306e\u671f\u9593\u3092\u8ffd\u8de1\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u4f01\u696d\u6226\u7565\u3001\u5f53\u5c40\u306e\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306e\u5b9f\u65bd\u3068\u7a2e\u985e\u3001\u88fd\u54c1\u306e\u7a2e\u985e\u3084\u6cbb\u7642\u9818\u57df\u306a\u3069\u306e\u8981\u56e0\u306b\u3064\u3044\u3066\u3082\u8abf\u67fb\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n

CIRS\u306f\u30012002\u5e74\u304b\u3089\u898f\u5236\u5f53\u5c40\u306e\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u3092\u5b9f\u65bd\u3057\u3066\u304a\u308a\u3001\u5f53\u5c40\u3068\u5171\u540c\u3067\u958b\u767a\u3057\u305f\u65b9\u6cd5\u8ad6\u3092\u7528\u3044\u3066like-for-like\u306a\u6bd4\u8f03\u3092\u884c\u3063\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\u3068\u5b9f\u52d9\u306b\u95a2\u3059\u308b\u72ec\u81ea\u306e\u30a4\u30f3\u30b5\u30a4\u30c8\u3092\u63d0\u4f9b\u3057\u3001\u6539\u5584\u3059\u3079\u304d\u70b9\u3092\u7279\u5b9a\u3057\u3066\u4f01\u696d\u3068\u5f53\u5c40\u306e\u6226\u7565\u306b\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n

 <\/p>\n

\u898f\u5236\u5be9\u67fb\u306e\u627f\u8a8d\u6642\u9593<\/h3>\n

\u904e\u53bb20\u5e74\u9593\u3067\u306f\u53ce\u675f\u3057\u3066\u3044\u305f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u30012019\u5e74\u306b\u306f6\u3064\u306e\u6a5f\u95a2\u9593\u3067\u627f\u8a8d\u6642\u9593\u306b\u5dee\u304c\u3042\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u307e\u3057\u305f\uff08\u56f31\uff09\u3002\u3057\u304b\u3057\u3001\u63d0\u51fa\u304b\u3089\u79d1\u5b66\u7684\u8a55\u4fa1\u306e\u7d42\u4e86\u307e\u3067\u306e\u6642\u9593\u3092\u6bd4\u8f03\u3059\u308b\u3068\u3001\u6a5f\u95a2\u9593\u3067\u306e\u3070\u3089\u3064\u304d\u306f\u5c11\u306a\u3044\u7d50\u679c\u3068\u306a\u308a\u307e\u3057\u305f\uff08\u56f31\u4e2d\u3001\u62ec\u5f27\u5185\u306e\u6570\u5b57\uff09\u3002\u3053\u306e\u3053\u3068\u306f\u3001\u5c11\u306a\u304f\u3068\u3082\u4e00\u90e8\u306e\u6a5f\u95a2\u3067\u306f\u3001\u79d1\u5b66\u7684\u5be9\u67fb\u7d42\u4e86\u5f8c\u306b\u4e8b\u52d9\u7684\u306a\u51e6\u7406\u3084\u30b9\u30dd\u30f3\u30b5\u30fc\u3068\u306e\u8ffd\u52a0\u4ea4\u6e09\u306a\u3069\u3001\u5168\u4f53\u7684\u306a\u627f\u8a8d\u6642\u9593\u306b\u5f71\u97ff\u3059\u308b\u6d3b\u52d5\u304c\u3042\u308b\u3053\u3068\u304c\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n

\"Regulatory<\/p>\n

\u56f31 – 2010\u5e74\u304b\u30892019\u5e74\u307e\u3067\u306e6\u3064\u306e\u898f\u5236\u5f53\u5c40\u306b\u304a\u3051\u308bNAS\u306e\u627f\u8a8d\u6642\u9593\u306e\u4e2d\u592e\u5024<\/p>\n

 <\/p>\n

\u627f\u8a8d\u6570<\/h3>\n

\u8457\u8005\u3089\u306f6\u3064\u306e\u6a5f\u95a2\u3067\u627f\u8a8d\u3055\u308c\u305fNAS\u306e\u6570\u306f\u3001\u904e\u53bb10\u5e74\u9593\u3067\u6982\u306d\u5897\u52a0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u767a\u898b\u3057\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u904e\u53bb5\u5e74\u9593\u3060\u3051\u3092\u8003\u616e\u3059\u308b\u3068\u3001FDA\u4ee5\u5916\u306e\u3059\u3079\u3066\u306e\u6a5f\u95a2\u306b\u3088\u308b\u627f\u8a8d\u306b\u4f38\u3073\u60a9\u307f \u304c\u3042\u308a\u3001FDA\u306b\u304a\u3051\u308b\u627f\u8a8d\u6570\u306f\u5897\u52a0\u3057\u7d9a\u3051\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u3001FDA\u3067\u65e9\u671f\u627f\u8a8d\u5236\u5ea6 \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\u306e\u4e2d\u306b\u306f\u3001\u7279\u306b\u4e2d\u5c0f\u4f01\u696d\u304b\u3089\u627f\u8a8d\u3055\u308c\u305f\u3082\u306e\u304c\u56fd\u969b\u5316\u3055\u308c\u306a\u3044\u3082\u306e\u304c\u3042\u308b\u3053\u3068\u304c\u539f\u56e0\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n

 <\/p>\n

\u533b\u85ac\u54c1\u306e\u56fd\u969b\u5316<\/h3>\n

\u8457\u8005\u3089\u306f2010-2014\u5e74\u304b\u30892015-2019\u5e74\u306b\u304b\u3051\u3066\u30016\u3064\u306e\u6a5f\u95a2\u3059\u3079\u3066\u3067\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u306e\u6570\u304c36\uff05\u5897\u52a0\u3057\u3066\u304a\u308a\u3001\u3088\u308a\u591a\u304f\u306e\u88fd\u54c1\u304c\u56fd\u969b\u5316\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u767a\u898b\u3057\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u5897\u52a0\u306f2009-2013\u5e74\u304b\u30892014-2018\u5e74\u306b\u6bd4\u3079\u3066\u6709\u610f\u306b\u5c0f\u3055\u304f\u3001\u56fd\u969b\u5316\u306e\u30da\u30fc\u30b9\u304c\u920d\u5316\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u793a\u5506\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n

\u533b\u85ac\u54c1\u306e\u56fd\u969b\u5316\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u305f\u8981\u56e0\u306f\u3001\u63d0\u51fa\u6642\u671f\u306a\u3069\u306e\u4f01\u696d\u6226\u7565\u3068\u4f01\u696d\u898f\u6a21\u3067\u3057\u305f\u30022015\u5e74\u304b\u30892019\u5e74\u306e\u9593\u306bFDA\u306b\u63d0\u51fa\u3055\u308c\u305f182\u306eNAS\u306e\u3046\u3061\u300137\uff05\u306fFDA\u3067\u306e\u307f\u627f\u8a8d\u3055\u308c\u3001\u305d\u306e\u3046\u306175\uff05\u306f\u975e\u30c8\u30c3\u30d7\u4f01\u696d\uff08\u30c8\u30c3\u30d7\u4f01\u696d\uff1a2019\u5e74\u306b30\u5104\u30c9\u30eb\u4ee5\u4e0a\u306e\u7814\u7a76\u958b\u767a\u4e88\u7b97\u3092\u6709\u3059\u308b\u4f01\u696d\u3068\u5b9a\u7fa9\uff09\u304b\u3089\u306e\u3082\u306e\u3067\u3057\u305f\u3002\u3053\u306e\u3053\u3068\u304b\u3089\u3001FDA\u3067\u627f\u8a8d\u3055\u308c\u305f\u533b\u85ac\u54c1\u306e\u5927\u534a\u304c\u56fd\u969b\u5316\u3055\u308c\u308b\u3053\u3068\u304c\u793a\u5506\u3055\u308c\u307e\u3057\u305f\u304c\u3001\u975e\u30c8\u30c3\u30d7\u4f01\u696d\u304c\u958b\u767a\u3057\u305f\u533b\u85ac\u54c1\u306e\u5834\u5408\u306f\u3088\u308a\u6642\u9593\u304c\u304b\u304b\u308b\u53ef\u80fd\u6027\u304c\u8003\u3048\u3089\u308c\u307e\u3057\u305f\u3002<\/p>\n

 <\/p>\n

\u898f\u5236\u7d4c\u8def\u306e\u5186\u6ed1\u5316<\/h3>\n

Facilitated regulatory pathways\uff08FRP\uff09\u306f\u3001\u6a19\u6e96\u7684\u306a\u5be9\u67fb\u30eb\u30fc\u30c8\u306b\u4ee3\u308f\u308b\u4ee3\u66ff\u624b\u6bb5\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u30a2\u30f3\u30e1\u30c3\u30c8\u30fb\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30cb\u30fc\u30ba\u306e\u3042\u308b\u533b\u85ac\u54c1\u306e\u5165\u624b\u3001\u5be9\u67fb\/\u627f\u8a8d\u3092\u30b9\u30e0\u30fc\u30ba\u306b\u3059\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u30022019\u5e74\u306bFDA\u304c\u627f\u8a8d\u3057\u305fNAS\u306e70\uff05\u304c\u5c11\u306a\u304f\u3068\u30821\u3064\u306eFRP\u306e\u6069\u6075\u3092\u53d7\u3051\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u4ed6\u306e\u6a5f\u95a2\u3067\u306f26\uff05\uff08EMA\uff09\u304b\u308942\uff05\uff08PMDA\uff09\u3068\u306a\u3063\u3066\u3044\u307e\u3059\uff08\u56f32\uff09\u3002<\/p>\n

\"Proportion<\/p>\n

\u56f32 – 2019\u5e74\u306b\u627f\u8a8d\u3055\u308c\u305fNAS\u306e\u3046\u3061\u3001\u5c11\u306a\u304f\u3068\u30821\u3064\u306eFRP\u306e\u6069\u6075\u3092\u53d7\u3051\u305f\u5272\u5408\uff08\u30aa\u30fc\u30d5\u30a1\u30f3\u3092\u9664\u304f\uff09\u3002<\/p>\n

\u8457\u8005\u3089\u306f\u307e\u305f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u30fb\u30ab\u30ca\u30c0\u30fb\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u30fb\u30b9\u30a4\u30b9\uff08ACSS\uff09\u30b3\u30f3\u30bd\u30fc\u30b7\u30a2\u30e0\u304c\u8a2d\u7acb\u3057\u305f\u30ef\u30fc\u30af\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u3082\u8abf\u67fb\u3057\u307e\u3057\u305f\u304c\u3001\u3053\u308c\u306f\u4ed6\u306e\u5fd7\u3092\u540c\u3058\u304f\u3059\u308b\u6a5f\u95a2\u304c\u30ea\u30bd\u30fc\u30b9\u3092\u5171\u6709\u3057\u3001\u4f01\u696d\u9593\u306e\u3084\u308a\u53d6\u308a\u3092\u5408\u7406\u5316\u3059\u308b\u305f\u3081\u306e\u30e2\u30c7\u30eb\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002ACSS\u4e0b\u3067\u306e\u30ef\u30fc\u30af\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u306e\u53d6\u308a\u6c7a\u3081\u306e\u4e00\u90e8\u3068\u3057\u3066\u3001\u5404\u6a5f\u95a2\u306f\u66f8\u985e\u306e\u7570\u306a\u308b\u90e8\u5206\u3092\u5be9\u67fb\u3057\u307e\u3059\u304c\u3001\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u306b\u95a2\u3057\u3066\u306f\u72ec\u7acb\u3057\u305f\u5224\u65ad\u3092\u4e0b\u3057\u307e\u3059\u30022018\u5e74\u304b\u30892019\u5e74\u306e\u9593\u306b\u30013\u3064\u306eNAS\u304cACSS\u306e\u30ef\u30fc\u30af\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u3092\u901a\u3058\u3066\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u3068TGA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u30022\u3064\u306e\u6a5f\u95a2\u9593\u3067\u627f\u8a8d\u6642\u9593\u306e\u4e2d\u592e\u5024\u306b\u5dee\u304c\u3042\u308a\u307e\u3057\u305f\u304c\u3001\u3053\u308c\u306f\u30ef\u30fc\u30af\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u7684\u306a\u6027\u8cea\u306b\u3088\u3063\u3066\u8aac\u660e\u3067\u304d\u307e\u3059\u3002<\/p>\n

 <\/p>\n

COVID-19\u306e\u6f5c\u5728\u7684\u5f71\u97ff<\/h3>\n

2019\u5e74\u4ee5\u964d\u306e\u30c7\u30fc\u30bf\u3092\u542b\u3080\u4eca\u5f8c\u306b\u95a2\u3059\u308bCIRS\u306e\u5206\u6790\u3067\u306f\u3001COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u304cNAS\u627f\u8a8d\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3084\u533b\u85ac\u54c1\u306e\u56fd\u969b\u5316\u3078\u306e\u5909\u5316\u304c\u793a\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u8fc5\u901f\u5be9\u67fb\u3084\u305d\u306e\u4ed6\u306eFRP\u306e\u5229\u7528\u53ef\u80fd\u6027\u3068\u5229\u7528\u306f\u3001\u30a2\u30f3\u30e1\u30c3\u30c8\u30cb\u30fc\u30ba\u3084COVID-19\u306e\u3088\u3046\u306a\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306e\u9375\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n

CIRS\u304b\u3089\u306e\u30d6\u30ea\u30fc\u30d5\u30a3\u30f3\u30b0\u5168\u6587\u306f\u3053\u3061\u3089<\/a>\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n

 <\/p>\n

1<\/sup>The six agencies included in the study were the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).<\/p>\n","protected":false},"excerpt":{"rendered":"

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