{"id":9582,"date":"2026-03-03T21:42:52","date_gmt":"2026-03-03T13:42:52","guid":{"rendered":"https:\/\/regask.com\/?p=9582"},"modified":"2026-03-03T21:43:42","modified_gmt":"2026-03-03T13:43:42","slug":"%e3%83%9e%e3%83%ac%e3%83%bc%e3%82%b7%e3%82%a2npra%e3%81%af%e3%80%81%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a8%93%e8%a3%bd%e5%93%81%e3%81%aegmp%e9%81%b5%e5%ae%88%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e6%9c%89","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","title":{"rendered":"NPRA \u30de\u30ec\u30fc\u30b7\u30a2\u3001\u6709\u80fd\u306a\u4eba\u6750\u306e\u5ba3\u8a00\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e742\u670823\u65e5,<\/strong> \u305d\u306e <strong>\u56fd\u7acb\u533b\u85ac\u54c1\u898f\u5236\u5e81 (NPRA)<\/strong> \u533b\u85ac\u54c1\u304a\u3088\u3073\u5316\u7ca7\u54c1\u7ba1\u7406\u898f\u5236\u306b\u57fa\u3065\u304f\u65b0\u305f\u306a\u6307\u4ee4\u3092\u767a\u8868\u3057\u3001\u8ffd\u52a0\u306e <strong>\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09<\/strong> \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u4ef6 <strong>\u6cbb\u9a13\u85ac<\/strong> \u30de\u30ec\u30fc\u30b7\u30a2\u306e\u81e8\u5e8a\u8a66\u9a13\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u306e\u6307\u4ee4\u306f\u3001 <strong>\u30e1\u30fc\u30ab\u30fc\u3001\u8f38\u5165\u696d\u8005\u3001\u30b9\u30dd\u30f3\u30b5\u30fc<\/strong> \u7533\u8acb\u3059\u308b<strong> \u81e8\u5e8a\u8a66\u9a13\u8f38\u5165\u30e9\u30a4\u30bb\u30f3\u30b9\uff08CTIL\uff09 <\/strong>\u307e\u305f\u306f<strong> \u81e8\u5e8a\u8a66\u9a13\u514d\u9664\uff08CTX\uff09 <\/strong>\u305d\u3057\u3066<strong> \u5373\u6642\u767a\u52b9\u3057\u307e\u3059\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1033689385\">\n\n\t<div id=\"col-1126165639\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1734889461\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1734889461 {\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-1631512099\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1631512099 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u65b0\u3057\u3044\u6307\u4ee4\u3067\u306f\u3001\u7533\u8acb\u8005\u306f <strong>\u6709\u80fd\u306a\u4eba\u6750\u306e\u5ba3\u8a00<\/strong> \u6cbb\u9a13\u85ac\u304c\u3001\u5f53\u5c40\u304c\u516c\u5f0fGMP\u8a3c\u660e\u66f8\u3092\u767a\u884c\u3057\u3066\u3044\u306a\u3044\u7ba1\u8f44\u533a\u57df\u3067\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001GMP\u9069\u5408\u306e\u6b63\u5f0f\u306a\u8a3c\u62e0\u3068\u3057\u3066\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u56fd\u304b\u3089\u8abf\u9054\u3055\u308c\u305f\u88fd\u54c1\u3082\u542b\u307e\u308c\u307e\u3059\u3002 <strong>\u4e2d\u56fd\u3001\u7c73\u56fd\u3001ASEAN\u8af8\u56fd\u3001\u305d\u306e\u4ed6\u306e\u5730\u57df<\/strong> GMP\u8a8d\u8a3c\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306a\u3057\u3002.<\/p>\n<p>\u5ba3\u8a00\u3067\u306f\u3001\u88fd\u9020\u6d3b\u52d5\u304c <strong>ICH \u307e\u305f\u306f PIC\/S GMP \u6a19\u6e96\u306b\u76f8\u5f53\u3057\u307e\u3059\u3002.<\/strong> \u307e\u305f\u3001\u4ee5\u4e0b\u3082\u542b\u307e\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059 <strong>\u76e3\u67fb\u306e\u8a73\u7d30<\/strong> \u8cc7\u683c\u306e\u3042\u308b\u4eba\u54e1\u306b\u3088\u3063\u3066\u5b9f\u65bd\u3055\u308c\u308b\u304b\u3001\u76e3\u67fb\u304c\u5b9f\u65bd\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001 <strong>\u66f8\u9762\u306b\u3088\u308b\u6b63\u5f53\u5316<\/strong> \u6839\u62e0\u3092\u8aac\u660e\u3059\u308b\u3002\u63d0\u51fa\u3055\u308c\u305f\u7533\u544a\u306b\u57fa\u3065\u304d\u3001, <strong>\u88fd\u9020\u73fe\u5834\u306fNPRA\u306e\u691c\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/strong> \u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u74b0\u3068\u3057\u3066\u3002.<\/p>\n<p>\u5168\u3066 <strong>\u65b0\u3057\u3044CTIL\u304a\u3088\u3073CTX\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/strong> \u5f71\u97ff\u3092\u53d7\u3051\u308b\u5730\u57df\u304b\u3089\u306e\u6cbb\u9a13\u85ac\u306b\u95a2\u308f\u308b\u3059\u3079\u3066\u306e\u4f01\u696d\u306f\u3001\u3053\u308c\u3089\u306e\u898f\u5b9a\u3092\u9075\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1126165639 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1287481375\" 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-1972096866\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1972096866 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u6307\u4ee4\u306f <strong>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong> GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u306a\u3044\u56fd\u304b\u3089\u6cbb\u9a13\u85ac\u3092\u8abf\u9054\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u4f9d\u983c\u8005\u306e\u305f\u3081\u306b\u3001NPRA\u306f\u3001\u9069\u683c\u8005\u5ba3\u8a00\u3092\u901a\u3058\u3066\u4ee3\u66ffGMP\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u6b63\u5f0f\u306b\u627f\u8a8d\u3059\u308b\u3053\u3068\u3067\u3001 <strong>\u56fd\u969b\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u305f\u898f\u5236\u3001,<\/strong> \u5f37\u5316\u3059\u308b <strong>\u76e3\u7763\u306e\u52b9\u7387\u6027\u3001,<\/strong> \u81e8\u5e8a\u8a66\u9a13\u306e\u627f\u8a8d\u306b\u5bfe\u3059\u308b\u624b\u7d9a\u304d\u4e0a\u306e\u969c\u58c1\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u306a\u304c\u3089\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u4fdd\u8a3c\u3092\u7dad\u6301\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1287481375 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1259350171\" 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-1160157397\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1160157397 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001 <strong>\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u81e8\u5e8a\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30fc\u30e0\u3001,<\/strong> \u540c\u69d8\u306b <strong>\u30e1\u30fc\u30ab\u30fc\u3001\u8f38\u5165\u696d\u8005\u3001\u30b9\u30dd\u30f3\u30b5\u30fc<\/strong> \u30de\u30ec\u30fc\u30b7\u30a2\u3067\u306e\u81e8\u5e8a\u8a66\u9a13\u7528\u306e\u6cbb\u9a13\u85ac\u306e\u8f38\u5165\u307e\u305f\u306f\u88fd\u9020\u306b\u643a\u308f\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1259350171 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2116575031\" 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-227112372\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-227112372 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u73fe\u5728\u304a\u3088\u3073\u4eca\u5f8c\u306e <strong>CTIL\u3068CTX<\/strong> <strong>\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/strong> \u5f71\u97ff\u3092\u53d7\u3051\u308b\u7ba1\u8f44\u533a\u57df\u304b\u3089\u4f9b\u7d66\u3055\u308c\u305f\u6cbb\u9a13\u85ac\u3092\u7279\u5b9a\u3059\u308b\u3002\u898f\u5236\u95a2\u9023\u696d\u52d9\u30c1\u30fc\u30e0\u306f\u3001 <strong>\u54c1\u8cea\u4fdd\u8a3c<\/strong> \u5fc5\u8981\u306a\u3082\u306e\u3092\u6e96\u5099\u3059\u308b <strong>\u6709\u80fd\u306a\u8077\u54e1\u306e\u5ba3\u8a00\u3001,<\/strong> GMP\u540c\u7b49\u6027\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3001\u76e3\u67fb\u6587\u66f8\u3001\u307e\u305f\u306f\u66f8\u9762\u306b\u3088\u308b\u6839\u62e0\u304c\u5b8c\u5168\u3067\u3042\u308a\u3001NPRA\u306e\u671f\u5f85\u306b\u6cbf\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3001\u793e\u5185\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u683c\u8a8d\u5b9a\u304a\u3088\u3073\u6587\u66f8\u5316\u30d7\u30ed\u30bb\u30b9\u3082\u898b\u76f4\u3057\u3001\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u898f\u5236\u8981\u4ef6\u306f\u7ba1\u8f44\u533a\u57df\u3092\u8d8a\u3048\u3066\u9032\u5316\u3057\u7d9a\u3051\u3066\u304a\u308a\u3001, <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u30c1\u30fc\u30e0\u304c\u5730\u57df\u306e GMP \u306e\u671f\u5f85\u3068\u63d0\u51fa\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u7d9a\u3051\u308b\u3053\u3068\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002. <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u306e\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u306b\u7a4d\u6975\u7684\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8 AI \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\u3067\u3059\u3002. <strong>\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\u3068\u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> \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. <a href=\"http:\/\/regask.com\/ja\/\"><strong>\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b <\/strong><\/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\/\"><strong> \u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2116575031 > .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-531614350\">\n\n\t<div id=\"col-66762033\" 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-2141788496\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2141788496 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW229157140 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW229157140 BCX0\">NPRA \u6307\u4ee4\u306b\u57fa\u3065\u304f\u6709\u80fd\u306a\u8077\u54e1\u306e\u5ba3\u8a00\u3068\u306f\u4f55\u3067\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW229157140 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-1205713829\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1205713829 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u308c\u306f\u3001\u516c\u5f0f\u306e GMP \u8a3c\u660e\u66f8\u3092\u767a\u884c\u3057\u306a\u3044\u7ba1\u8f44\u533a\u57df\u3067\u88fd\u9020\u3055\u308c\u305f\u6cbb\u9a13\u85ac\u306e GMP \u6e96\u62e0\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u9808\u6587\u66f8\u3067\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-66762033 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1995151913\" 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>\u3053\u306e\u8981\u4ef6\u306e\u5f71\u97ff\u3092\u53d7\u3051\u308b\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3069\u308c\u3067\u3059\u304b?<\/h4>\n\t<div id=\"gap-1644659112\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1644659112 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3059\u3079\u3066\u65b0\u3057\u304f\u306a\u3063\u305f <strong>CTIL\u304a\u3088\u3073CTX\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/strong> \u5f71\u97ff\u3092\u53d7\u3051\u305f\u5730\u57df\u304b\u3089\u4f9b\u7d66\u3055\u308c\u305f\u6cbb\u9a13\u85ac\u306b\u95a2\u308f\u308b\u3082\u306e\u306f\u3001\u3053\u308c\u306b\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1995151913 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-619771882\" 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>\u5ba3\u8a00\u3067\u306f\u3069\u306e\u3088\u3046\u306a GMP \u57fa\u6e96\u3092\u53c2\u7167\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-5471330\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-5471330 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5ba3\u8a00\u306fGMP\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044<strong> ICH\u307e\u305f\u306fPIC\/S\u898f\u683c\u3001,<\/strong> \u76e3\u67fb\u306e\u8a73\u7d30\u307e\u305f\u306f\u66f8\u9762\u306b\u3088\u308b\u6b63\u5f53\u6027\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-619771882 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1214959878\" 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>RegASK \u306f\u3001\u7d44\u7e54\u304c\u3053\u306e NPRA \u6307\u4ee4\u306b\u6e96\u62e0\u3059\u308b\u306e\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3061\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-857709873\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-857709873 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> \u898f\u5236\u304a\u3088\u3073\u54c1\u8cea\u30c1\u30fc\u30e0\u304c NPRA \u306e\u66f4\u65b0\u3092\u8ffd\u8de1\u3057\u3001\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u9069\u7528\u6027\u3092\u8a55\u4fa1\u3057\u3001GMP \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5ba3\u8a00\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6587\u66f8\u5316\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5408\u7406\u5316\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1214959878 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 23 February 2026, the National Pharmaceutical Regulatory Agency (NPRA) published a new directive under the Drugs and Cosmetics Control Regulations introducing additional Good Manufacturing Practices (GMP) compliance requirements for investigational medicinal products used in clinical trials in Malaysia. The directive affects manufacturers, importers, and sponsors applying for Clinical Trial Import Licenses (CTIL) or Clinical Trial Exemptions (CTX) and is effective immediately.<\/p>","protected":false},"author":41,"featured_media":9584,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,584],"tags":[],"class_list":["post-9582","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-malaysia-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NPRA Malaysia Mandates Declaration of Competent Personnel<\/title>\n<meta name=\"description\" content=\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. 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