{"id":1147,"date":"2019-09-17T12:09:20","date_gmt":"2019-09-17T04:09:20","guid":{"rendered":"https:\/\/regask.com\/?p=1147"},"modified":"2024-11-16T05:12:39","modified_gmt":"2024-11-15T21:12:39","slug":"%e7%b1%b3%e5%9b%bd-eu-mra-%e3%82%a2%e3%83%83%e3%83%97%e3%83%87%e3%83%bc%e3%83%88","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/us-eu-mra-update\/","title":{"rendered":"\u6700\u65b0\u60c5\u5831\uff1a\u7c73\u56fd\u3068\u30ab\u30ca\u30c0\u9593\u306e\u76f8\u4e92\u627f\u8a8d\u5354\u5b9a\u2026"},"content":{"rendered":"<p>2019\u5e747\u670811\u65e5\u73fe\u5728\u3001\u79fb\u884c\u671f\u9593\u306f\u7d42\u4e86\u3057\u3066\u304a\u308a\u3001\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/mutual-recognition-agreements-mra#united-states-section\" target=\"_blank\" rel=\"noopener noreferrer\">\u76f8\u4e92\u627f\u8a8d\u5354\u5b9a<\/a>\u00a0\u7c73\u56fd\u3068\u6b27\u5dde\u9023\u5408\u306e\u9593\u3067\u7de0\u7d50\u3055\u308c\u305fMRA\uff08\u76f8\u4e92\u627f\u8a8d\u5354\u5b9a\uff09\u304c\u9032\u884c\u4e2d\u3067\u3059\u3002<\/p>\n<h2 class=\"h4\">\u306e <strong>\u79c1\u305f\u3061<\/strong> \u305d\u3057\u3066 <strong>\u6b27\u5dde\u9023\u5408<\/strong><\/h2>\n<p>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u9577\u5e74\u306e\u8abf\u67fb\u3092\u7d4c\u3066\u3001EU\u52a0\u76df28\u30ab\u56fd\u3059\u3079\u3066\u304c\u3001\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u305f\u65bd\u8a2d\u3067\u4eba\u7528\u533b\u85ac\u54c1\u3092\u88fd\u9020\u3059\u308b\u80fd\u529b\u304c\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u305f\u3002\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\" target=\"_blank\" rel=\"noopener noreferrer\">\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09<\/a>\u540c\u69d8\u306b\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\uff08EC\uff09\u306f\u3001FDA\u304cEU\u3068\u540c\u30ec\u30d9\u30eb\u306eGMP\u691c\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u624b\u9806\u3092\u6574\u5099\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u305f\u3002<\/p>\n<h2 class=\"h4\">\u3053\u308c\u306f\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u304b <strong>\u5e73\u5747<\/strong>?<\/h2>\n<p>\u305d\u306e\u7d50\u679c\u3001EU\u52a0\u76df\u56fd\u306fMRA\u306e\u5bfe\u8c61\u3068\u306a\u308b\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u30d0\u30c3\u30c1\u30c6\u30b9\u30c8\u3092\u884c\u3046\u7fa9\u52d9\u304c\u306a\u304f\u306a\u308a\u3001FDA\u306fEU\u306e\u691c\u67fb\u7d50\u679c\u306b\u983c\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u305f\u3081\u3001\u91cd\u8907\u3057\u305f\u63aa\u7f6e\u304c\u6392\u9664\u3055\u308c\u308b\u3002MRA\u306b\u3088\u308a\u3001FDA\u3068EU\u306f\u3001EU\u3067\u88fd\u9020\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u691c\u67fb\u306e\u53d6\u308a\u7d44\u307f\u3092\u96c6\u4e2d\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u00a0<a href=\"https:\/\/www.oncozine.com\/united-states-and-europe-reach-milestone-agreement-on-mutual-recognition-of-inspections\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u4ed6\u306e\u56fd\u306e\u65bd\u8a2d<\/a>.<\/p>\n<p>\u65b0\u3057\u3044\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u4e3b\u306b\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u3001\u751f\u7269\u88fd\u5264\u3001\u52d5\u7269\u7528\u533b\u85ac\u54c1\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u3044\u304f\u3064\u304b\u306e\u9664\u5916\u4e8b\u9805\u304c\u3042\u308a\u307e\u3059\u3002\u52d5\u7269\u7528\u88fd\u54c1\u306f\u73fe\u5728\u542b\u307e\u308c\u3066\u3044\u307e\u305b\u3093\u304c\u30012019 \u5e74 12 \u6708 15 \u65e5\u307e\u3067\u306b\u691c\u8a0e\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30ef\u30af\u30c1\u30f3\u3084\u8840\u6f3f\u7531\u6765\u88fd\u54c1\u3092\u88fd\u9020\u3059\u308b\u65bd\u8a2d\u306e\u73fe\u5728\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96 (CGMP) \u3082\u542b\u307e\u308c\u3066\u3044\u307e\u305b\u3093\u304c\u30012022 \u5e74 7 \u6708 15 \u65e5\u307e\u3067\u306b\u691c\u8a0e\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002\u6b21\u306e\u88fd\u54c1\u306f\u542b\u307e\u308c\u3066\u304a\u3089\u305a\u3001\u691c\u8a0e\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<\/p>\n<ul>\n<li>1. \u4eba\u9593\u306e\u8840\u6db2<\/li>\n<li>2. \u30d2\u30c8\u8840\u6f3f<\/li>\n<li>3. \u4eba\u9593\u306e\u7d44\u7e54\u3068\u81d3\u5668<\/li>\n<li>4. \u7363\u533b\u514d\u75ab\u5b66<\/li>\n<\/ul>\n<p>MRA\u306e\u5bfe\u8c61\u3068\u306a\u308b\u533b\u85ac\u54c1\u306e\u5b8c\u5168\u306a\u30ea\u30b9\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3053\u3092\u30af\u30ea\u30c3\u30af\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/mutual-recognition-agreements-mra#united-states-section\" target=\"_blank\" rel=\"noopener noreferrer\">\u3053\u3053<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>2019\u5e747\u670811\u65e5\u73fe\u5728\u3001\u79fb\u884c\u671f\u9593\u306f\u7d42\u4e86\u3057\u3001\u7c73\u56fd\u3068\u6b27\u5dde\u9023\u5408\u306e\u9593\u3067\u7de0\u7d50\u3055\u308c\u305f\u76f8\u4e92\u627f\u8a8d\u5354\u5b9a\uff08MRA\uff09\u306e\u65bd\u884c\u304c\u958b\u59cb\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u3068EU \u9577\u5e74\u306e\u5be9\u67fb\u3092\u7d4c\u3066\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001EU\u52a0\u76df28\u304b\u56fd\u3059\u3079\u3066\u304c\u3001\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff08GMP\uff09\u306b\u6e96\u62e0\u3057\u305f\u65bd\u8a2d\u3067\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u3092\u88fd\u9020\u3059\u308b\u80fd\u529b\u3092\u6709\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3057\u305f\u3002\u540c\u69d8\u306b\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\uff08EC\uff09\u306f\u3001FDA\u304cEU\u3068\u540c\u7b49\u306e\u30ec\u30d9\u30eb\u3067GMP\u691c\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u624b\u9806\u3092\u6574\u5099\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u4f55\u3092\u610f\u5473\u3059\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f \u305d\u306e\u7d50\u679c\u3001EU\u52a0\u76df\u56fd\u306f\u3082\u306f\u3084\u2026<\/p>","protected":false},"author":39,"featured_media":2207,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,30],"tags":[],"class_list":["post-1147","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-and-biotech-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US-EU Mutual Recognition Agreement | RegASK<\/title>\n<meta name=\"description\" content=\"Stay informed on the latest updates to the Mutual Recognition Agreement (MRA) between the US and EU with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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