{"id":9628,"date":"2026-03-11T15:24:15","date_gmt":"2026-03-11T07:24:15","guid":{"rendered":"https:\/\/regask.com\/?p=9628"},"modified":"2026-03-11T15:24:15","modified_gmt":"2026-03-11T07:24:15","slug":"%e8%8b%b1%e5%9b%bd%e5%8c%bb%e8%96%ac%e5%93%81%e3%83%bb%e5%8c%bb%e7%99%82%e8%a3%bd%e5%93%81%e8%a6%8f%e5%88%b6%e5%ba%81%ef%bc%88mhra%ef%bc%89%e3%81%8c%e5%ae%87%e5%ae%99%e7%a9%ba%e9%96%93%e3%81%a7","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/uk-mhra-issues-guidance-on-regulatory-approval-for-space-manufactured-pharmaceuticals\/","title":{"rendered":"\u82f1\u56fdMHRA\u3001\u5b87\u5b99\u95a2\u9023\u6a5f\u5668\u306e\u898f\u5236\u627f\u8a8d\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u306e\u4e0a\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67085\u65e5<\/span><\/b><span data-contrast=\"auto\">, 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class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-929128639 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u8a73\u7d30<\/h2>\n\t<div id=\"gap-994770573\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-994770573 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u65b0\u305f\u306b\u5c0e\u5165\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u65e2\u5b58\u306e\u82f1\u56fd\u533b\u85ac\u54c1\u898f\u5236\u306f\u3001\u5fae\u5c0f\u91cd\u529b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u4f7f\u7528\u3057\u3066\u8ecc\u9053\u4e0a\u3067\u88fd\u9020\u3055\u308c\u308b\u533b\u85ac\u54c1\u306b\u3082\u9069\u7528\u3055\u308c\u308b\u3002<\/span><\/b><span data-contrast=\"auto\">. 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data-contrast=\"auto\">\u696d\u754c\u306e\u7406\u89e3\u3092\u3055\u3089\u306b\u6df1\u3081\u308b\u305f\u3081\u3001\u5404\u6a5f\u95a2\u306f\u4ee5\u4e0b\u3092\u516c\u958b\u3059\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u539f\u5247\u306b\u57fa\u3065\u3044\u305f\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5b87\u5b99\u7a7a\u9593\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u88fd\u9020\u306b\u95a2\u3059\u308b\u6f5c\u5728\u7684\u306a\u898f\u5236\u7d4c\u8def\u3092\u793a\u3059\u3002\u3053\u308c\u3089\u306e\u4e8b\u4f8b\u306f\u3001\u65e2\u5b58\u306e\u898f\u5236\u304c\u5fae\u5c0f\u91cd\u529b\u74b0\u5883\u306b\u304a\u3051\u308b\u69d8\u3005\u306a\u88fd\u9020\u30b7\u30ca\u30ea\u30aa\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u7d44\u7e54\u304c\u8a55\u4fa1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u3067\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">MHRA\u306e\u79d1\u5b66\u304a\u3088\u3073\u898f\u5236\u306b\u95a2\u3059\u308b\u52a9\u8a00\u30b5\u30fc\u30d3\u30b9\u3078\u306e\u65e9\u671f\u306e\u95a2\u4e0e<\/span><\/b><span data-contrast=\"auto\">, \u4f01\u696d\u304c\u958b\u767a\u8a08\u753b\u6bb5\u968e\u3067\u898f\u5236\u5f53\u5c40\u306b\u76f8\u8ac7\u3057\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u8981\u4ef6\u3092\u3088\u308a\u3088\u304f\u7406\u89e3\u3059\u308b\u3088\u3046\u4fc3\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6700\u5f8c\u306b\u3001\u3053\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u533b\u85ac\u54c1\u304a\u3088\u3073\u5b87\u5b99\u6280\u8853\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u306b\u308f\u305f\u308b\u9023\u643a\u5f37\u5316<\/span><\/b><span data-contrast=\"auto\">, \u5b87\u5b99\u7a7a\u9593\u3067\u88fd\u9020\u3055\u308c\u305f\u533b\u85ac\u54c1\u306e\u9577\u671f\u7684\u306a\u5546\u696d\u5316\u3092\u4fc3\u9032\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-107470760 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1685942498\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-1439860742\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1439860742 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">\u3053\u306e\u898f\u5236\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u3001\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>\u5fae\u5c0f\u91cd\u529b\u74b0\u5883\u3067\u88fd\u9020\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u3001\u65e2\u5b58\u306e\u82f1\u56fd\u306e\u533b\u85ac\u54c1\u304a\u3088\u3073\u5b87\u5b99\u98db\u884c\u898f\u5236\u304c\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u306b\u3064\u3044\u3066\u3001\u3088\u308a\u660e\u78ba\u306a\u8aac\u660e\u304c\u5fc5\u8981\u3002<\/strong><\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\"><strong>.<\/strong> \u306b\u3088\u308b\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u78ba\u7acb\u3059\u308b<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3001\u898f\u5236\u30b5\u30f3\u30c9\u30dc\u30c3\u30af\u30b9\u306a\u3069\u3001\u3053\u306e\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u652f\u63f4\u3057\u307e\u3059\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u7dad\u6301\u3059\u308b<\/span><span class=\"NormalTextRun SCXW10975365 BCX0\">\u00a0\u898f\u5236\u76e3\u7763\u3082\u4fc3\u9032\u3057\u307e\u3059\u3002<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">\u898f\u5236\u306e\u6574\u5408\u6027\u3001\u958b\u767a\u8a08\u753b\u306e\u6539\u5584\u3001\u305d\u3057\u3066\u5b87\u5b99\u6280\u8853\u3092\u6d3b\u7528\u3057\u305f\u65b0\u305f\u306a\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u6280\u8853\u306e\u305f\u3081\u306e\u52b9\u7387\u7684\u306a\u9053\u7b4b<\/span><\/span><span class=\"TextRun SCXW10975365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW10975365 BCX0\">.<\/span><\/span><span class=\"EOP SCXW10975365 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1685942498 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1830918101\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8ab0\u306b\u95a2\u4fc2\u304c\u3042\u308b\u304b<\/h2>\n\t<div id=\"gap-1443170070\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1443170070 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u7279\u306b\u4ee5\u4e0b\u306e\u4eba\u3005\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u88fd\u85ac\u4f1a\u793e\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u4f01\u696d\u3001\u304a\u3088\u3073\u5fae\u5c0f\u91cd\u529b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u63d0\u4f9b\u4f01\u696d<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0\u958b\u767a\u306e\u63a2\u6c42\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u751f\u7269\u88fd\u5264\u3001\u5148\u9032\u6cbb\u7642\u6cd5\u3001\u305d\u306e\u4ed6\u306e\u8907\u96d1\u306a\u533b\u85ac\u54c1<\/span><\/span><\/strong><span class=\"TextRun SCXW248171813 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0\u305d\u308c\u306f\u00a0<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">\u5229\u70b9<\/span><span class=\"NormalTextRun SCXW248171813 BCX0\">\u00a0\u5fae\u5c0f\u91cd\u529b\u88fd\u9020\u74b0\u5883\u304b\u3089\u3002.<\/span><\/span><span class=\"EOP SCXW248171813 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1830918101 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1757819785\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-372652628\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-372652628 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u95a2\u4fc2\u3059\u308b\u7d44\u7e54\u00a0<\/span><b><span data-contrast=\"auto\">\u5b87\u5b99\u7a7a\u9593\u3092\u5229\u7528\u3057\u305f\u533b\u85ac\u54c1\u88fd\u9020<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6982\u8aac\u3055\u308c\u305f\u898f\u5236\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u898b\u76f4\u3057\u3001\u73fe\u5728\u307e\u305f\u306f\u8a08\u753b\u4e2d\u306e\u53d6\u308a\u7d44\u307f\u304c\u65b0\u3057\u3044\u67a0\u7d44\u307f\u306b\u5408\u81f4\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u3088\u3046\u306a\u6280\u8853\u3092\u958b\u767a\u3057\u3066\u3044\u308b\u4f01\u696d\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">MHRA\u306e\u79d1\u5b66\u7684\u304a\u3088\u3073\u898f\u5236\u4e0a\u306e\u52a9\u8a00\u30b5\u30fc\u30d3\u30b9\u306b\u65e9\u671f\u304b\u3089\u95a2\u4e0e\u3059\u308b<\/span><\/b><span data-contrast=\"auto\">\u00a0\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u7d4c\u8def\u3001\u958b\u767a\u4e0a\u306e\u8003\u616e\u4e8b\u9805\u3001\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u4ef6\u3092\u3088\u308a\u6df1\u304f\u7406\u89e3\u3059\u308b\u305f\u3081\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u5b87\u5b99\u7a7a\u9593\u3067\u306e\u88fd\u9020\u3068\u3044\u3063\u305f\u65b0\u8208\u6280\u8853\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u9032\u5316\u3059\u308b\u306b\u3064\u308c\u3001\u898f\u5236\u62c5\u5f53\u30c1\u30fc\u30e0\u306f\u65b0\u305f\u306a\u6307\u91dd\u3084\u5206\u91ce\u6a2a\u65ad\u7684\u306a\u653f\u7b56\u52d5\u5411\u3092\u5e38\u306b\u628a\u63e1\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308b\u3002.\u00a0<a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a>\u00a0\u306f\u4e00\u6d41\u306e\u00a0<\/span><b><span data-contrast=\"auto\">\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u3001\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u3092\u7a4d\u6975\u7684\u306b\u4e57\u308a\u8d8a\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u9ad8\u5ea6\u306a\u00a0<\/span><b><span data-contrast=\"auto\">\u5c02\u9580\u5bb6\u304c\u95a2\u4e0e\u3059\u308b\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI<\/span><\/b><span data-contrast=\"auto\">,\u00a0<a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002.\u00a0<\/span><b><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/ja\/\">\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/a> \u307e\u305f\u306f <a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\">\u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/a><\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1757819785 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-976371184\">\n\n\t<div id=\"col-1461793890\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h3>\n\t<div id=\"gap-1446456049\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1446456049 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW283686 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW283686 BCX0\">\u5b87\u5b99\u7a7a\u9593\u3067\u88fd\u9020\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308bMHRA\uff08\u82f1\u56fd\u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u898f\u5236\u5e81\uff09\u306e\u6307\u91dd\u306f\u4f55\u3067\u3059\u304b\uff1f<\/span><\/span><span class=\"EOP SCXW283686 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-2146149603\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2146149603 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\">\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u65e2\u5b58\u306e\u82f1\u56fd\u306e\u533b\u85ac\u54c1\u304a\u3088\u3073\u5b87\u5b99\u98db\u884c\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u3001\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\">\u5fae\u5c0f\u91cd\u529b\u74b0\u5883<\/span><\/span><\/strong><span class=\"TextRun SCXW68796879 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW68796879 BCX0\"><strong>,<\/strong> \u958b\u767a\u3001\u898f\u5236\u5f53\u5c40\u3068\u306e\u9023\u643a\u3001\u305d\u3057\u3066\u88fd\u54c1\u306e\u5730\u7403\u3078\u306e\u5e30\u9084\u3092\u542b\u3080\u3002.<\/span><\/span><span class=\"EOP SCXW68796879 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1461793890 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1039535102\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW90362748 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW90362748 BCX0\">\u518d\u53c2\u5165\u898f\u5236\u30b5\u30f3\u30c9\u30dc\u30c3\u30af\u30b9\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/span><\/span><span class=\"EOP SCXW90362748 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1985906328\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1985906328 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">\u306e\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">\u518d\u53c2\u5165\u898f\u5236\u30b5\u30f3\u30c9\u30dc\u30c3\u30af\u30b9<\/span><\/span><\/strong><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\"><strong>\u00a0<\/strong>\u3053\u308c\u306f\u3001\u4f01\u696d\u304c\u5b89\u5168\u306a\u5fa9\u5e30\u306b\u5411\u3051\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u8a55\u4fa1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u305f\u898f\u5236\u30c6\u30b9\u30c8\u74b0\u5883\u3067\u3059\u3002<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">\u5b87\u5b99\u3067\u88fd\u9020\u3055\u308c\u305f\u533b\u85ac\u54c1<\/span><\/span><\/strong><span class=\"TextRun SCXW250166262 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250166262 BCX0\">\u00a0\u8ecc\u9053\u4e0a\u304b\u3089\u5730\u7403\u3078\u3002.<\/span><\/span><span class=\"EOP SCXW250166262 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1039535102 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1254824316\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW14021316 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW14021316 BCX0\">\u5fae\u5c0f\u91cd\u529b\u4e0b\u3067\u306e\u88fd\u9020\u306b\u6700\u3082\u95a2\u9023\u6027\u306e\u9ad8\u3044\u533b\u85ac\u54c1\u306e\u7a2e\u985e\u306f\u3069\u308c\u3067\u3059\u304b\uff1f<\/span><\/span><span class=\"EOP SCXW14021316 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1852024259\" class=\"gap-element 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The guidance aims to support companies developing space-enabled pharmaceutical manufacturing while clarifying regulatory expectations for approval and market access in the United Kingdom.\u00a0<\/p>","protected":false},"author":43,"featured_media":9629,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,526,35],"tags":[],"class_list":["post-9628","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-united-kingdom-regulations","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK MHRA Issues Guidance on Regulatory Approval<\/title>\n<meta name=\"description\" content=\"Explore the UK MHRA guidance on regulatory approval for space-manufactured 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