{"id":1774,"date":"2020-04-06T15:09:33","date_gmt":"2020-04-06T06:09:33","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/%e6%96%b0%e8%a6%8f%e6%b4%bb%e6%80%a7%e7%89%a9%e8%b3%aa%ef%bc%88nas%ef%bc%89%e3%81%aeema%e3%81%a8fda%e3%81%ae%e3%83%ac%e3%83%93%e3%83%a5%e3%83%bc%e7%b5%90%e6%9e%9c%e3%81%af%e4%b8%80%e8%87%b4%e3%81%97\/?lang=ja"},"modified":"2020-04-06T15:09:33","modified_gmt":"2020-04-06T06:09:33","slug":"do-ema-and-fda-review-outcomes-for-new-active-substances-nass-align","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/do-ema-and-fda-review-outcomes-for-new-active-substances-nass-align\/","title":{"rendered":"\u65b0\u898f\u6d3b\u6027\u7269\u8cea\uff08NAS\uff09\u306eEMA\u3068FDA\u306e\u30ec\u30d3\u30e5\u30fc\u7d50\u679c\u306f\u4e00\u81f4\u3057\u3066\u3044\u308b\u304b\uff1f"},"content":{"rendered":"

\u82f1\u8a9e\u539f\u6587<\/a>
\n\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u3088\u308a\u78ba\u5b9f\u306a\u3082\u306e\u306b\u3059\u308b\u305f\u3081\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3068\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u6d3b\u52d5\u3068\u76ee\u6a19\u3092\u4e00\u81f4\u3055\u305b\u308b\u305f\u3081\u306e\u63aa\u7f6e\u3092\u8b1b\u3058\u3066\u3044\u307e\u3059\u3002Centre for Innovation in Regulatory Science\uff08CIRS\uff09<\/a>\u3068\u30b5\u30ce\u30d5\u30a3\u306f\u3001\u3053\u308c\u307e\u3067\u306e\u9032\u6357\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b\u7814\u7a76\u3067\u63d0\u643a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

 <\/p>\n

\u4e16\u754c\u4e2d\u306e\u898f\u5236\u6a5f\u95a2\u306e\u5171\u901a\u306e\u76ee\u6a19\u306f\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u76e3\u7763\u3059\u308b\u3053\u3068\u3067\u3001\u56fd\u6c11\u306e\u5065\u5eb7\u3068\u798f\u7949\u3092\u5b88\u308b\u3053\u3068\u3067\u3059\u3002\u540c\u3058\u30c7\u30fc\u30bf\u304c\u63d0\u4f9b\u3055\u308c\u305f\u5834\u5408\u3001\u898f\u5236\u6a5f\u95a2\u9593\u3067\u7d50\u679c\u306b\u5927\u304d\u306a\u5dee\u306f\u751f\u3058\u306a\u3044\u3053\u3068\u304c\u5408\u7406\u7684\u306b\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u70b9\u3092\u8003\u616e\u3057\u3066\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3068\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001\u691c\u67fb\u5831\u544a\u66f8\u3084\u88fd\u54c1\u5b89\u5168\u6027\u60c5\u5831\u306e\u5171\u6709\u3001\u4e26\u884c\u3057\u3066\u79d1\u5b66\u7684\u30a2\u30c9\u30d0\u30a4\u30b9\u3092\u63d0\u4f9b\u3059\u308b\u306a\u3069\u3001\u3044\u304f\u3064\u304b\u306e\u5171\u540c\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3067\u3001\u305d\u308c\u305e\u308c\u306e\u6d3b\u52d5\u3068\u76ee\u6a19\u3092\u4e00\u81f4\u3055\u305b\u308b\u305f\u3081\u306e\u63aa\u7f6e\u3092\u8b1b\u3058\u3066\u304d\u307e\u3057\u305f\u3002 \u3068\u306f\u3044\u3048\u3001\u5be9\u67fb\u4e2d\u306e\u610f\u601d\u6c7a\u5b9a\u306f\u4f9d\u7136\u3068\u3057\u3066EMA\u3068FDA\u3067\u72ec\u7acb\u3057\u3066\u884c\u308f\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u7d50\u679c\u3092\u6bd4\u8f03\u3059\u308b\u3055\u3089\u306a\u308b\u7814\u7a76\u306b\u3088\u308a\u30012\u3064\u306e\u6a5f\u95a2\u9593\u3067\u898f\u5236\u4e0a\u306e\u52e7\u544a\u304c\u4e56\u96e2\u3057\u3066\u3044\u308b\u5177\u4f53\u7684\u306a\u7406\u7531\u304c\u660e\u3089\u304b\u306b\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

 <\/p>\n

\u7d50\u679c\u306e\u6574\u5408\u6027\u306e\u6c7a\u5b9a<\/strong><\/h4>\n

CIRS\u3068Sanofi SA Global Regulatory Science and Policy\u3092\u4ee3\u8868\u3059\u308b\u8457\u8005\u3089\u306f\u3001\u65b0\u898f\u6d3b\u6027\u7269\u8cea\uff08NAS\uff09\u306b\u3064\u3044\u3066\u4e21\u6a5f\u95a2\u304b\u3089\u306e\u5be9\u67fb\u7d50\u679c\u304c\u4e00\u81f4\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u30012014\u5e74\u304b\u30892016\u5e74\u307e\u3067\u306bFDA\u3068EMA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305fNAS\u3092\u8a55\u4fa1\u3057\u3001\u5be9\u67fb\u7d50\u679c\u306e\u72b6\u6cc1\u30922017\u5e74\u307e\u3067\u8ffd\u8de1\u8abf\u67fb\u3057\u307e\u3057\u305f\u3002\u8457\u8005\u3089\u306f\u30012\u3064\u306e\u6a5f\u95a2\u3078\u306e\u300c\u540c\u6642\u7533\u8acb\u300d\u3092\u4e92\u3044\u306b3\u30f6\u6708\u4ee5\u5185\u306b\u767a\u751f\u3057\u305f\u3082\u306e\u3068\u5b9a\u7fa9\u3057\u3001Facilitated Regulatory Pathways\uff08FRPs\uff09\u3068\u30aa\u30fc\u30d5\u30a1\u30f3\u6307\u5b9a\u306e\u4f7f\u7528\u3001\u7533\u8acb\u3055\u308c\u305f\u9069\u5fdc\u75c7\u3068\u627f\u8a8d\u3055\u308c\u305f\u9069\u5fdc\u75c7\u3068\u306e\u6bd4\u8f03\u3001\u627f\u8a8d\u307e\u3067\u306e\u6642\u9593\u3092\u8a55\u4fa1\u3057\u307e\u3057\u305f\u3002<\/p>\n

 <\/p>\n

\u627f\u8a8d\u9593\u306e\u6574\u5408\u6027<\/strong><\/h4>\n

2014\u5e74\u304b\u30892016\u5e74\u306b\u304b\u3051\u3066115\u306eNAS\u304cEMA\u3082\u3057\u304f\u306fFDA\u3001\u307e\u305f\u306f\u305d\u306e\u4e21\u65b9\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u3046\u3061\u300182\u54c1\u76ee\u306fFDA\u3068EMA\u306e\u4e21\u65b9\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u3066\u304a\u308a\uff0871\uff05\uff09\u30012\u3064\u306e\u6a5f\u95a2\u306e\u9593\u3067\u4e00\u822c\u7684\u306a\u30ec\u30d9\u30eb\u306e\u6574\u5408\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001FDA\u304cEMA\u3088\u308a\u3082\u591a\u304f\u306e\u5316\u5408\u7269\u3092\u627f\u8a8d\u3057\u3066\u3044\u308b\u70b9\u306b\u9055\u3044\u304c\u3042\u308a\u300124\u306eNAS\u304cFDA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u304cEMA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305a\uff0821\uff05\uff09\u30019\u3064\u306eNAS\u304cEMA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u304cFDA\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u306a\u304b\u3063\u305f\uff088\uff05\uff09\u3068\u3044\u3046\u7d50\u679c\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u627f\u8a8d\u3055\u308c\u306a\u304b\u3063\u305f\u306e\u306fEMA\u3084FDA\u306b\u3088\u308b\u62d2\u7d76\u3067\u306f\u306a\u304f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u3088\u308b\u63d0\u51fa\u8cc7\u6599\u4e0d\u8db3\u3001\u63d0\u51fa\u3084\u627f\u8a8d\u304c\u8a66\u9a13\u671f\u9593\u5f8c\u306b\u767a\u751f\u3057\u305f\u3053\u3068\u3001\u307e\u305f\u306f\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u304c\u8a66\u9a13\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u306a\u304b\u3063\u305f\u3053\u3068\u306b\u8d77\u56e0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

 <\/p>\n

\u627f\u8a8d\u3055\u308c\u305f\u9069\u5fdc\u75c7\u306e\u9055\u3044<\/strong><\/h4>\n

EMA\u3068FDA\u306b\u540c\u6642\u306b\u63d0\u51fa\u3055\u308c\u305f46\u306eNAS\u306b\u3064\u3044\u3066\u3001\u9069\u5fdc\u75c7\u60c5\u5831\u3092\u53d6\u5f97\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u308946\u306eNAS\u306e\u3046\u3061\u300133\u306eNAS\uff0872\uff05\uff09\u3067\u306f\u540c\u3058\u9069\u5fdc\u75c7\u304cEMA\u3068FDA\u306b\u63d0\u51fa\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u6b8b\u308a\u306e13\u306eNAS\uff0828\uff05\uff09\u306f\u3001\u7570\u306a\u308b\u9069\u5fdc\u75c7\u3092\u8ffd\u6c42\u3059\u308b\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u3088\u3063\u3066\u63d0\u51fa\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n

\u540c\u3058\u9069\u5fdc\u75c7\u304c\u63d0\u51fa\u3055\u308c\u305f33\u306eNAS\u3067\u306f\u300124\u306eNAS\u3067EMA\u3068FDA\u306b\u540c\u3058\u9069\u5fdc\u75c7\u304c\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\uff0873\uff05\uff09\u3002\u8208\u5473\u6df1\u3044\u3053\u3068\u306b\u30019\u3064\u306eNAS\u3067\u306f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u304c\u540c\u3058\u9069\u5fdc\u75c7\u60c5\u5831\u3092\u63d0\u51fa\u3057\u305f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u7570\u306a\u308b\u9069\u5fdc\u75c7\u304c\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u30dd\u30a4\u30f3\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u4f8b\u3048\u3070\u627f\u8a8d\u5f8c\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3084\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u691c\u8a0e\u3059\u308b\u3053\u3068\u7b49\u306b\u3088\u3063\u3066\u3001\u3055\u3089\u306b\u8abf\u67fb\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u30012\u3064\u306e\u6a5f\u95a2\u304c\u305d\u308c\u305e\u308c\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u5206\u6790\u306b\u304a\u3044\u3066\u69d8\u3005\u306a\u8981\u7d20\u306b\u4e0e\u3048\u308b\u91cd\u8981\u6027\u306e\u9055\u3044\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n

 <\/p>\n

Facilitated Regulatory Pathways<\/strong><\/h4>\n

\u540c\u6642\u306b\u63d0\u51fa\u3055\u308c\u305f52\u54c1\u76ee\u306b\u3064\u3044\u3066\u306f\u3001FDA\u306f\u5be9\u67fb\u3092\u8fc5\u901f\u5316\u3057\u3001\u533b\u85ac\u54c1\u3092\u30aa\u30fc\u30d5\u30a1\u30f3\u306b\u6307\u5b9a\u3059\u308b\u50be\u5411\u304c\u5f37\u304b\u3063\u305f\u305f\u3081\u3001EMA\u306e\u57fa\u6e96\/\u5b9a\u7fa9\u306e\u53b3\u683c\u5316\u3084\u6307\u5b9a\u30d7\u30ed\u30bb\u30b9\u306e\u67d4\u8edf\u6027\u306e\u4f4e\u3055\u3092\u793a\u5506\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u4e21\u6a5f\u95a2\u306f52\u306eNAS\u306e\u3046\u306149\u306eNAS\u306b\u3064\u3044\u3066\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\uff08EMA\u306e\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u307e\u305f\u306fFDA\u306e\u8fc5\u901f\u627f\u8a8d\uff09\u306b\u5408\u610f\u3057\u307e\u3057\u305f\u3002<\/p>\n

 <\/p>\n

EMA<\/strong>\u306b\u3088\u308b\u627f\u8a8d\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u5ef6\u9577<\/strong><\/h4>\n

\u627f\u8a8d\u307e\u3067\u306e\u671f\u9593\u306e\u4e2d\u592e\u5024\u306f\u3001EMA\uff08409\u65e5\uff09\u3088\u308a\u3082FDA\uff08319\u65e5\uff09\u306e\u65b9\u304c90\u65e5\u65e9\u3044\u7d50\u679c\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u306f\u3044\u304f\u3064\u304b\u306e\u7406\u7531\u304c\u3042\u308a\u307e\u3059\u3002\u7b2c\u4e00\u306b\u3001FDA\u306f\u69d8\u3005\u306a\u72b6\u6cc1\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u5e45\u5e83\u3044\u8fc5\u901f\u5316\u30d7\u30ed\u30bb\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001EMA\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u59d4\u54e1\u4f1a\u306e\u610f\u898b\u66f8\u3068\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u6c7a\u5b9a\u3068\u3044\u30462\u3064\u306e\u6b63\u5f0f\u306a\u30b9\u30c6\u30c3\u30d7\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001EMA\u306e\u8fc5\u901f\u8a55\u4fa1\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u6700\u8fd1\u306e\u6539\u8a02\u3068Priority Medicines\u306e\u958b\u59cb\u306b\u3088\u308a\u3001\u3053\u308c\u3089\u306e\u9055\u3044\u306f\u7de9\u548c\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

 <\/p>\n

 <\/p>\n

\u672c\u7814\u7a76\u306e\u5168\u6587\u306f\u3053\u3061\u3089\u304b\u3089\u304a\u8aad\u307f\u3044\u305f\u3060\u3051\u307e\u3059\u3002<\/strong><\/h4>\n

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.<\/a><\/em><\/p>\n

 <\/p>\n

\u8457\u8005\u306b\u3064\u3044\u3066<\/strong><\/h4>\n

Professor Thomas K\u00fchler, Head of Regulatory Science and Policy, EU\/AMESA, Sanofi SA<\/p>\n

Dr Magda Bujar, Manager, Strategic Development, CIRS<\/p>\n

Dr Neil McAuslane, Director, CIRS<\/p>\n

Dr Lawrence Liberti, Head, Regulatory Collaborations, CIRS<\/p>\n

 <\/p>\n

 <\/p>\n

Centre for Innovation in Regulatory Science<\/strong>\uff08<\/strong>CIRS<\/strong>\uff09\u306b\u3064\u3044\u3066<\/strong><\/h4>\n

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\u82f1\u8a9e\u539f\u6587 \u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u3088\u308a\u78ba\u5b9f\u306a\u3082\u306e\u306b\u3059\u308b\u305f\u3081\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3068\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u6d3b\u52d5\u3068\u76ee\u6a19\u3092\u4e00\u81f4\u3055\u305b\u308b\u305f\u3081\u306e\u63aa\u7f6e\u3092\u8b1b\u3058\u3066\u3044\u307e\u3059\u3002Centre for Innovation in Regulatory Science\uff08CIRS\uff09\u3068\u30b5\u30ce\u30d5\u30a3\u306f\u3001\u3053\u308c\u307e\u3067\u306e\u9032\u6357\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b\u7814\u7a76\u3067\u63d0\u643a\u3057\u3066\u3044\u307e\u3059\u3002   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  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