{"version":"1.0","provider_name":"Tilleke &amp; Gibbins","provider_url":"https:\/\/www.tilleke.com\/ja","author_name":"Joel Akins","author_url":"https:\/\/www.tilleke.com\/ja\/author\/joel\/","title":"\u30d9\u30c8\u30ca\u30e0\u3001\u533b\u85ac\u54c1\u767b\u9332\u306b\u95a2\u3059\u308b\u65b0\u305f\u306a\u898f\u5247\u3092\u767a\u8868 - Tilleke &amp; Gibbins","type":"rich","width":600,"height":338,"html":"<blockquote class=\"wp-embedded-content\" data-secret=\"lge7Hr0I8j\"><a href=\"https:\/\/www.tilleke.com\/ja\/insights\/%e3%83%99%e3%83%88%e3%83%8a%e3%83%a0%e3%80%81%e5%8c%bb%e8%96%ac%e5%93%81%e7%99%bb%e9%8c%b2%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e6%96%b0%e3%81%9f%e3%81%aa%e8%a6%8f%e5%89%87%e3%82%92%e7%99%ba%e8%a1%a8\">\u30d9\u30c8\u30ca\u30e0\u3001\u533b\u85ac\u54c1\u767b\u9332\u306b\u95a2\u3059\u308b\u65b0\u305f\u306a\u898f\u5247\u3092\u767a\u8868<\/a><\/blockquote><iframe sandbox=\"allow-scripts\" security=\"restricted\" src=\"https:\/\/www.tilleke.com\/ja\/insights\/%e3%83%99%e3%83%88%e3%83%8a%e3%83%a0%e3%80%81%e5%8c%bb%e8%96%ac%e5%93%81%e7%99%bb%e9%8c%b2%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e6%96%b0%e3%81%9f%e3%81%aa%e8%a6%8f%e5%89%87%e3%82%92%e7%99%ba%e8%a1%a8\/embed\/#?secret=lge7Hr0I8j\" width=\"600\" height=\"338\" title=\"&#8220;\u30d9\u30c8\u30ca\u30e0\u3001\u533b\u85ac\u54c1\u767b\u9332\u306b\u95a2\u3059\u308b\u65b0\u305f\u306a\u898f\u5247\u3092\u767a\u8868&#8221; &#8212; Tilleke &amp; Gibbins\" data-secret=\"lge7Hr0I8j\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\" class=\"wp-embedded-content\"><\/iframe><script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\n\/*! This file is auto-generated *\/\n!function(d,l){\"use strict\";l.querySelector&&d.addEventListener&&\"undefined\"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!\/[^a-zA-Z0-9]\/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret=\"'+t.secret+'\"]'),o=l.querySelectorAll('blockquote[data-secret=\"'+t.secret+'\"]'),c=new RegExp(\"^https?:$\",\"i\"),i=0;i<o.length;i++)o[i].style.display=\"none\";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute(\"style\"),\"height\"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):\"link\"===t.message&&(r=new URL(s.getAttribute(\"src\")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener(\"message\",d.wp.receiveEmbedMessage,!1),l.addEventListener(\"DOMContentLoaded\",function(){for(var e,t,s=l.querySelectorAll(\"iframe.wp-embedded-content\"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute(\"data-secret\"))||(t=Math.random().toString(36).substring(2,12),e.src+=\"#?secret=\"+t,e.setAttribute(\"data-secret\",t)),e.contentWindow.postMessage({message:\"ready\",secret:t},\"*\")},!1)))}(window,document);\n\/* ]]> *\/\n<\/script>","description":"\u30d9\u30c8\u30ca\u30e0\u4fdd\u5065\u7701\uff08Ministry of Health \uff09\u306f\u30012025\u5e745\u670816\u65e5\u3001\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u54c1\u539f\u6599\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u901a\u9054\u7b2c12\/2025\/TT-BYT\uff08Circular No. 12\/2025\/TT-BYT on registration of drugs and drug materials\uff09\uff08\u4ee5\u4e0b\u3001\u901a\u9054\u7b2c12\u53f7\u3068\u3044\u3046\u3002\uff09\u3092\u516c\u5e03\u3057\u305f\u3002\u901a\u9054\u7b2c12\u53f7\u306f\u3001\u533b\u85ac\u54c1\u767b\u9332\u306b\u95a2\u3059\u308b\u73fe\u884c\u898f\u5247\u3067\u3042\u308b\u901a\u9054\u7b2c08\/2022\/TT-BYT\uff08\u6539\u6b63\u7248\uff09\u3001\u59d4\u8a17\u88fd\u9020\u53ca\u3073\u6280\u8853\u79fb\u8ee2\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u901a\u9054\u7b2c16\/2023\/TT-BYT\u3001\u4e26\u3073\u306b\u5e02\u8ca9\u85ac\u30ea\u30b9\u30c8\u3092\u516c\u8868\u3059\u308b\u901a\u9054\u7b2c07\/2017\/TT-BYT\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u3042\u308a\u30012025\u5e747\u67081\u65e5\u306b\u65bd\u884c\u3055\u308c\u308b\u3002 \u901a\u9054\u7b2c12\u53f7\u306e\u4e3b\u306a\u898f\u5b9a\u306e\u4e00\u90e8\u3092\u4ee5\u4e0b\u306b\u6982\u8aac\u3059\u308b\u3002 &nbsp; \u5e02\u8ca9\u85ac\u306e\u898f\u5236 \u901a\u9054\u7b2c12\u53f7\u306f\u3001\u5f93\u6765\u901a\u9054\u7b2c07\/2017\/TT-BYT\u3067\u898f\u5b9a\u3055\u308c\u3066\u3044\u305f\u5e02\u8ca9(over-the-counter)\u85ac\u306e\u8a73\u7d30\u306a\u30ea\u30b9\u30c8\u3092\u5ec3\u6b62\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u5206\u985e\u7528\u56fa\u5b9a\u30ea\u30b9\u30c8\u306b\u4f9d\u62e0\u3059\u308b\u65b9\u6cd5\u306b\u4ee3\u3048\u3066\u3001\u901a\u9054\u7b2c12\u53f7\u3067\u306f\u3001\u975e\u51e6\u65b9\u85ac\uff0f\u5e02\u8ca9\u85ac\u306e\u5206\u985e\u306b\u95a2\u3059\u308b\u539f\u5247\u3001\u57fa\u6e96\u3001\u304a\u3088\u3073\u5177\u4f53\u7684\u306a\u65b9\u6cd5\u306b\u57fa\u3065\u304f\u65b0\u305f\u306a\u67a0\u7d44\u307f\u3092\u5c0e\u5165\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u5b89\u5168\u6027\u306e\u5411\u4e0a\u3001\u8fc5\u901f\u306a\u30a2\u30af\u30bb\u30b9\u306e\u78ba\u4fdd\u3001\u5b9f\u969b\u306e\u4f7f\u7528\u72b6\u6cc1\u3068\u4f9b\u7d66\u72b6\u6cc1\u306e\u53cd\u6620\u3001\u305d\u3057\u3066\u56fd\u969b\u57fa\u6e96\u3078\u306e\u9069\u5408\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u308b\u3002 \u65e2\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u533b\u85ac\u54c1\u306f\u3001\u8ca9\u58f2\u627f\u8a8d\uff08marketing authorization\uff09\u306e\u6709\u52b9\u671f\u9593\u4e2d\u3001\u305d\u306e\u5206\u985e\uff08\u3059\u306a\u308f\u3061\u3001\u51e6\u65b9\u85ac\u307e\u305f\u306f\u975e\u51e6\u65b9\u85ac\uff09\u304c\u7dad\u6301\u3055\u308c\u3001\u8ca9\u58f2\u627f\u8a8d\u306e\u66f4\u65b0\u6642\u306b\u518d\u5206\u985e\u304c\u691c\u8a0e\u3055\u308c\u308b\u3002\u5206\u985e\u306e\u5909\u66f4\u3092\u7533\u8acb\u3059\u308b\u5834\u5408\u3001\u8ca9\u58f2\u627f\u8a8d\u4fdd\u6709\u8005\u306f\u30d9\u30c8\u30ca\u30e0\u533b\u85ac\u54c1\u7ba1\u7406\u5c40\uff08Drug Administration of Vietnam\uff09\u306b\u5909\u66f4\u7533\u8acb\u7528\u66f8\u985e\uff08variation registration dossier\uff09\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 \u73fe\u5728 \u30d9\u30c8\u30ca\u30e0\u533b\u85ac\u54c1\u7ba1\u7406\u5c40 \u306b\u3088\u3063\u3066\u8a55\u4fa1\u4e2d\u306e\u533b\u85ac\u54c1\u767b\u9332\u7528\u66f8\u985e\u306b\u3064\u3044\u3066\u306f\u3001\u901a\u9054\u7b2c12\u53f7\u306b\u5b9a\u3081\u3089\u308c\u305f\u65b0\u3057\u3044\u898f\u5b9a\u306b\u5f93\u3063\u3066\u5206\u985e\u304c\u8a55\u4fa1\u3055\u308c\u308b\u3002 &nbsp; 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\u898b\u89e3 \u901a\u9054\u7b2c12\u53f7\u306f\u3001\u30d9\u30c8\u30ca\u30e0\u306b\u304a\u3044\u3066\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u54c1\u539f\u6599\u3092\u88fd\u9020\u30fb\u53d6\u5f15\u3059\u308b\u4f01\u696d\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3002\u3053\u308c\u3089\u306e\u4f01\u696d\u306f\u3001\u6539\u6b63\u898f\u5b9a\u3092\u9069\u6642\u306b\u9075\u5b88\u3067\u304d\u308b\u3088\u3046\u3001\u65b0\u3057\u3044\u898f\u5247\u3092\u5fb9\u5e95\u7684\u306b\u691c\u8a0e\u3059\u308b\u3053\u3068\u3092\u63d0\u6848\u3059\u308b\u3002 &nbsp; \u5099\u8003\uff1a\u672c\u548c\u6587\u306f\u82f1\u6587\u8a18\u4e8b\u3092\u7ffb\u8a33\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u539f\u6587\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u30ea\u30f3\u30af\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002 Vietnam Issues New Regulations on Drug Registration"}