{"id":477262,"date":"2024-04-03T17:22:55","date_gmt":"2024-04-03T09:22:55","guid":{"rendered":"https:\/\/law.asia\/?p=477262"},"modified":"2024-06-18T14:35:09","modified_gmt":"2024-06-18T06:35:09","slug":"healthtech-regulatory-issues-japan","status":"publish","type":"post","link":"https:\/\/law.asia\/ja\/healthtech-regulatory-issues-japan\/","title":{"rendered":"\u5317\u30a2\u30b8\u30a2\u3067\u306e\u30d8\u30eb\u30b9\u30c6\u30c3\u30af\u898f\u5236\u306b\u95a2\u3059\u308b\u554f\u984c\u306e\u6bd4\u8f03\uff1a\u65e5\u672c"},"content":{"rendered":"<table style=\"margin-top: 0px; height: 12px;\" width=\"700\">\n<tbody style=\"border: 1px solid transparent; width: 100%; background-color: #f79433;\">\n<tr style=\"border: 1px solid transparent;\">\n<td style=\"width: 25%; margin: 0px; padding-top: 5px; padding-bottom: 5px; border-right: 2px solid #ffffff;\" valign=\"middle\">\n<p style=\"margin-bottom: 0px; text-align: center;\"><b> \u65e5\u672c<\/b><\/p>\n<\/td>\n<td style=\"width: 25%; margin: 0px; padding-top: 5px; padding-bottom: 5px; border-right: 2px solid #ffffff;\" valign=\"middle\">\n<p style=\"margin-bottom: 0px; text-align: center;\"><a href=\"https:\/\/law.asia\/ja\/healthtech-regulatory-issues-korea\/\"><span style=\"color: #ffffff;\"><b> \u97d3\u56fd<\/b><\/span><\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p style=\"text-align: justify;\">\u533b\u7642\u6280\u8853\u306f\u65e5\u672c\u3067\u5927\u304d\u306a\u6ce8\u76ee\u3092\u96c6\u3081\u3066\u304a\u308a\u3001\u65e5\u672c\u306e\u533b\u7642\u7523\u696d\u306e\u5e02\u5834\u898f\u6a21\u306f\u4eca\u5f8c\u3082\u62e1\u5927\u3059\u308b\u3053\u3068\u304c\u898b\u8fbc\u307e\u308c\u307e\u3059\u3002\u7d4c\u6e08\u7523\u696d\u7701\u306e\u5831\u544a\u66f8\u306b\u3088\u308b\u3068\u3001\u533b\u7642\u7523\u696d\u306e\u7523\u696d\u4fa1\u5024\u306f2025\u5e74\u307e\u3067\u306b33\u5146\u5186\uff082300\u5104\u7c73\u30c9\u30eb\uff09\u306b\u9054\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u533b\u7642\u6280\u8853\u306b\u95a2\u3059\u308b\u7279\u8a31\u306e\u51fa\u9858\u4ef6\u6570\u306f\u7740\u5b9f\u306b\u5897\u52a0\u3057\u3066\u304a\u308a\u3001\u65e5\u672c\u7279\u8a31\u5e81\u306b\u3088\u308c\u3070\u30012013\u5e74\u304b\u30892019\u5e74\u306b\u304b\u3051\u3066\u4e16\u754c\u5168\u4f53\u3067\u500d\u5897\u3057\u3066\u3044\u307e\u3059\u3002\u65e5\u672c\u653f\u5e9c\u306f\u3001\u30d8\u30eb\u30b9\u30c6\u30c3\u30af\u304a\u3088\u3073\u533b\u7642\u30c7\u30b8\u30bf\u30eb\u30c8\u30e9\u30f3\u30b9\u30d5\u30a9\u30fc\u30e1\u30fc\u30b7\u30e7\u30f3\uff08\u4ee5\u4e0b\u300cDX\u300d\u3068\u3044\u3044\u307e\u3059\uff09\u3092\u63a8\u9032\u3057\u3066\u304a\u308a\u3001DX\u306e\u9032\u6357\u72b6\u6cc1\u3092\u5171\u6709\u30fb\u691c\u8a3c\u3059\u308b\u305f\u3081\u30012022\u5e74\u306b\u5185\u95a3\u5e9c\u306b\u3044\u308f\u3086\u308b\u300c\u533b\u7642DX\u63a8\u9032\u672c\u90e8\u300d\u3092\u8a2d\u7f6e\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u4efb\u52d9\u306f\u3001\u500b\u4eba\u5065\u5eb7\u8a18\u9332 (PHR) \u306e\u5229\u7528\u3092\u4fc3\u9032\u3059\u308b\u3053\u3068\u306e\u3088\u3046\u3067\u3042\u308a\u3001\u63a8\u9032\u672c\u90e8\u306f\u653f\u5e9c\u304c\u767a\u884c\u3059\u308bID\u30ab\u30fc\u30c9\u304c\u500b\u4eba\u5065\u5eb7\u8a18\u9332\u306e\u30dd\u30fc\u30bf\u30eb\u3068\u306a\u308b\u3053\u3068\u3092\u671f\u5f85\u3057\u3066\u3044\u307e\u3059\u3002\u3069\u306e\u3088\u3046\u306a\u65b9\u5411\u306b\u9032\u3080\u306b\u305b\u3088\u3001\u533b\u7642DX\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u30d8\u30eb\u30b9\u30c6\u30c3\u30af\u306b\u304a\u3044\u3066\u3001\u500b\u4eba\u60c5\u5831\u4fdd\u8b77\u306f\u91cd\u8981\u306a\u6cd5\u7684\u8ab2\u984c\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u60c5\u5831\u5171\u6709\u306b\u95a2\u3059\u308b\u554f\u984c<\/strong><\/span><\/h2>\n<figure id=\"attachment_469490\" aria-describedby=\"caption-attachment-469490\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469492 size-full\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/Koji-Sugimura.jpg\" alt=\"Koji Sugimura\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469490\" class=\"wp-caption-text\"><b> \u6749\u6751 \u5149\u55e3<\/b><br \/>\u30de\u30cd\u30fc\u30b8\u30f3\u30b0\u30d1\u30fc\u30c8\u30ca\u30fc\u3001\u5f01\u8b77\u58eb<br \/>\u5f01\u8b77\u58eb\u30fb\u5f01\u7406\u58eb<br \/>\u6749\u6751\u842c\u56fd\u7279\u8a31\u6cd5\u5f8b\u4e8b\u52d9\u6240<br \/>\u6771\u4eac<br \/>\u96fb\u5b50\u30e1\u30fc\u30eb\uff1a<a href=\"mailto:kjs@sugimura.partners\">kjs@sugimura.partners<\/a><\/figcaption><\/figure>\n<p style=\"text-align: justify;\">\u533b\u7642DX\u306f\u3001\u5927\u91cf\u306e\u533b\u7642\u60c5\u5831\u306e\u5165\u624b\u53ef\u80fd\u6027\u306e\u5411\u4e0a\u3068\u3001\u500b\u4eba\u60c5\u5831\u306e\u9069\u5207\u306a\u4fdd\u8b77\u3068\u3044\u3046\u76f8\u53cd\u3059\u308b\u8ab2\u984c\u3092\u540c\u6642\u306b\u89e3\u6c7a\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p style=\"text-align: justify;\">\u533b\u7642\u60c5\u5831\u306f\u5f53\u7136\u306e\u3053\u3068\u306a\u304c\u3089\u300c\u500b\u4eba\u60c5\u5831\u300d\u306b\u5206\u985e\u3055\u308c\u3001\u65e5\u672c\u306e\u500b\u4eba\u60c5\u5831\u306e\u4fdd\u8b77\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\uff08\u4ee5\u4e0b\u300c\u500b\u4eba\u60c5\u5831\u4fdd\u8b77\u6cd5\u300d\u3068\u3044\u3044\u307e\u3059\uff09\u306b\u57fa\u3065\u304d\u4fdd\u8b77\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u533b\u7642\u60c5\u5831\u306f\u300c\u8981\u914d\u616e\u500b\u4eba\u60c5\u5831\u300d\u3068\u3057\u3066\u3001\u3088\u308a\u53b3\u91cd\u306a\u4fdd\u8b77\u306e\u5bfe\u8c61\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u500b\u4eba\u60c5\u5831\u4fdd\u8b77\u6cd5\u3067\u306f\u3001\u539f\u5247\u3068\u3057\u3066\u3001\u8981\u914d\u616e\u500b\u4eba\u60c5\u5831\u3092\u7b2c\u4e09\u8005\u306b\u63d0\u4f9b\u3059\u308b\u306b\u306f\u30c7\u30fc\u30bf\u4e3b\u4f53\u306e\u540c\u610f\u3092\u5f97\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u500b\u5225\u306e\u30aa\u30d7\u30c8\u30a4\u30f3\u306b\u3088\u308b\u540c\u610f\u306e\u53d6\u5f97\u306f\u3001\u7814\u7a76\u7b49\u306e\u305f\u3081\u306b\u5927\u91cf\u306e\u533b\u7642\u60c5\u5831\u3092\u53ce\u96c6\u30fb\u5206\u6790\u3057\u305f\u3044\u3068\u8003\u3048\u308b\u533b\u7642\u6a5f\u95a2\u306b\u3068\u3063\u3066\u3001\u5b9f\u52d9\u4e0a\u56f0\u96e3\u306a\u4f5c\u696d\u3067\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u500b\u4eba\u60c5\u5831\u4fdd\u8b77\u6cd5\u3067\u306f\u3001\u3053\u308c\u306b\u5bfe\u3059\u308b\u4ee3\u66ff\u624b\u6bb5\u304c\u898f\u5b9a\u3055\u308c\u3066\u304a\u308a\u3001\u533b\u7642\u60c5\u5831\u3092\u542b\u3080\u8981\u914d\u616e\u500b\u4eba\u60c5\u5831\u306f\u3001\u500b\u4eba\u3092\u7279\u5b9a\u3067\u304d\u306a\u3044\u3088\u3046\u306b\u533f\u540d\u5316\u3055\u308c\u3066\u3044\u308c\u3070\u3001\u30c7\u30fc\u30bf\u4e3b\u4f53\u306e\u540c\u610f\u306a\u3057\u306b\u7b2c\u4e09\u8005\u306b\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u306e\u4ee3\u66ff\u624b\u6bb5\u3092\u7528\u3044\u308b\u5834\u5408\u3001\u5404\u533b\u7642\u6a5f\u95a2\u306f\u30c7\u30fc\u30bf\u3092\u533f\u540d\u5316\u3059\u308b\u3068\u3044\u3046\u8ca0\u62c5\u3092\u5f37\u3044\u3089\u308c\u307e\u3059\u3002\u3082\u3046\u4e00\u3064\u306e\u6b20\u70b9\u306f\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u306b\u306f\u76f8\u4e92\u53c2\u7167\u60c5\u5831\u304c\u6b20\u5982\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u3092\u53d7\u9818\u3057\u305f\u7814\u7a76\u6a5f\u95a2\u306f\u3001\u6a5f\u95a2\u6a2a\u65ad\u7684\u306a\u5206\u6790\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u3053\u3068\u3067\u3059\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u6b21\u4e16\u4ee3\u306e\u6cd5\u5f8b<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\">\u3053\u306e\u3088\u3046\u306a\u8ab2\u984c\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306b\u30012018\u5e745\u670811\u65e5\u306b\u3001\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\uff08\u6b63\u5f0f\u540d\u79f0\u300c\u533b\u7642\u5206\u91ce\u306e\u7814\u7a76\u958b\u767a\u306b\u8cc7\u3059\u308b\u305f\u3081\u306e\u533f\u540d\u52a0\u5de5\u533b\u7642\u60c5\u5831\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u300d\uff09\u304c\u65bd\u884c\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p style=\"text-align: justify;\">\u3053\u306e\u6cd5\u5f8b\u306f\u3001\u5065\u5eb7\u8a3a\u65ad\u7d50\u679c\u3084\u533b\u7642\u8a18\u9332\u7b49\u306e\u533f\u540d\u5316\u3055\u308c\u305f\u500b\u4eba\u533b\u7642\u60c5\u5831\u306e\u3001\u533b\u7642\u5206\u91ce\u306e\u7814\u7a76\u958b\u767a\u3078\u306e\u6d3b\u7528\u306e\u63a8\u9032\u3092\u76ee\u7684\u3068\u3057\u3066\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u540c\u6cd5\u3067\u306f\u3001\u7533\u8acb\u4e8b\u696d\u8005\u304c\u4e00\u5b9a\u306e\u6280\u8853\u7684\u57fa\u6e96\uff08\u9ad8\u5ea6\u306a\u60c5\u5831\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u5341\u5206\u306a\u533f\u540d\u5316\u6280\u8853\u3092\u6709\u3057\u3066\u3044\u308b\u304b\u7b49\uff09\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u5426\u304b\u3001\u304a\u3088\u3073\u7533\u8acb\u4e8b\u696d\u8005\u304c\u533b\u7642\u60c5\u5831\u306e\u7ba1\u7406\u30fb\u5229\u7528\u3092\u76ee\u7684\u3068\u3057\u3066\u3001\u533f\u540d\u5316\u3092\u9069\u5207\u304b\u3064\u78ba\u5b9f\u306b\u5b9f\u65bd\u3067\u304d\u308b\u304b\u5426\u304b\u3092\u3001\u653f\u5e9c\u304c\u5be9\u67fb\u3059\u308b\u8a8d\u8a3c\u5236\u5ea6\u306b\u3064\u3044\u3066\u3082\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u533b\u7642\u6a5f\u95a2\u306f\u3001\u30c7\u30fc\u30bf\u4e3b\u4f53\u304c\u533b\u7642\u60c5\u5831\u306e\u63d0\u4f9b\u3092\u62d2\u5426\uff08\u30aa\u30d7\u30c8\u30a2\u30a6\u30c8\uff09\u3057\u306a\u3044\u9650\u308a\u3001\u8a8d\u8a3c\u3055\u308c\u305f\u4e8b\u696d\u8005\u306b\u533b\u7642\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u4e8b\u696d\u8005\u306f\u3001\u60c5\u5831\u3092\u533f\u540d\u5316\u3057\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u3092\u533b\u7642\u7814\u7a76\u958b\u767a\u306e\u305f\u3081\u306b\u7814\u7a76\u6a5f\u95a2\u306b\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u3064\u307e\u308a\u3001\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\u306f\u3001\u500b\u4eba\u306e\u6a29\u5229\u3068\u5229\u76ca\u3092\u4fdd\u8b77\u3057\u3064\u3064\u3001\u30c7\u30fc\u30bf\u4e3b\u4f53\u304c\u533b\u7642\u60c5\u5831\u306e\u63d0\u4f9b\u3092\u62d2\u5426\u3057\u306a\u3044\u9650\u308a\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u4e8b\u696d\u8005\u306b\u306e\u307f\u533b\u7642\u60c5\u5831\u304c\u63d0\u4f9b\u3055\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u533b\u7642\u60c5\u5831\u306e\u5229\u7528\u3092\u4fc3\u9032\u3059\u308b\u4ed5\u7d44\u307f\u3092\u7b56\u5b9a\u3059\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u305f\u3082\u306e\u3067\u3059\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\u306e\u6539\u6b63<\/strong><\/span><\/h2>\n<figure id=\"attachment_469494\" aria-describedby=\"caption-attachment-469494\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469496 size-full\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/Mitsukuni-Terada.jpg\" alt=\"Mitsukuni Terada\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469494\" class=\"wp-caption-text\"><b> \u5bfa\u7530 \u5149\u90a6<\/b><br \/>\u6cd5\u52d9\u90e8\u9577<br \/>\u5f01\u8b77\u58eb<br \/>\u5f01\u8b77\u58eb\u30fb\u5f01\u7406\u58eb<br \/>\u6749\u6751\u842c\u56fd\u7279\u8a31\u6cd5\u5f8b\u4e8b\u52d9\u6240<br \/>\u6771\u4eac<br \/>\u96fb\u5b50\u30e1\u30fc\u30eb\uff1a<a href=\"mailto:m.terada@sugimura.partners\">m.terada@sugimura.partners<\/a><\/figcaption><\/figure>\n<p style=\"text-align: justify;\">\u3057\u304b\u3057\u3001\u8a8d\u8a3c\u3055\u308c\u305f\u4e8b\u696d\u8005\u304c\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u306e\u5f62\u3067\u3057\u304b\u7814\u7a76\u6a5f\u95a2\u306b\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3067\u304d\u306a\u3044\u3068\u3044\u3046\u8af8\u554f\u984c\u304c\u3001\u672a\u89e3\u6c7a\u306e\u307e\u307e\u53d6\u308a\u6b8b\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u610f\u5473\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">(1)\u7814\u7a76\u6a5f\u95a2\u304c\u3001\u5c11\u6570\u306e\u75c7\u4f8b\u306e\u30c7\u30fc\u30bf\u3084\u7279\u7570\u306a\u30c7\u30fc\u30bf\u3092\u5e0c\u671b\u3057\u3066\u3082\u3001\u305d\u306e\u3088\u3046\u306a\u30c7\u30fc\u30bf\u306f\u4ed6\u306e\u30c7\u30fc\u30bf\u3068\u7d44\u307f\u5408\u308f\u305b\u308b\u3068\u500b\u4eba\u304c\u7279\u5b9a\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u5b9f\u969b\u306b\u306f\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u305b\u3093\u3002<\/p>\n<p style=\"text-align: justify;\">(2) \u6539\u6b63\u524d\u306e\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\u3067\u306f\u3001\u7d4c\u6642\u7684\u306a\u75c5\u72b6\u306e\u5909\u5316\u3092\u8ffd\u8de1\u3059\u308b\u305f\u3081\u306b\u3001\u500b\u3005\u306e\u60a3\u8005\u306e\u533b\u7642\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3057\u7d9a\u3051\u308b\u3053\u3068\u306f\u307b\u307c\u4e0d\u53ef\u80fd\u3067\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">(3)\u7814\u7a76\u6a5f\u95a2\u304c\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3057\u305f\u7d50\u679c\u3001\u3055\u3089\u306b\u7814\u7a76\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u304c\u3068\u5224\u660e\u3057\u305f\u3068\u3057\u3066\u3082\u3001\u30c7\u30fc\u30bf\u4e3b\u4f53\u306e\u533b\u7642\u8a18\u9332\u304b\u3089\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u306e\u5f62\u5f0f\u3067\u4ed6\u306e\u533b\u7642\u60c5\u5831\u306e\u63d0\u4f9b\u3092\u53d7\u3051\u308b\u3053\u3068\u306f\u3001\u307b\u307c\u4e0d\u53ef\u80fd\u3067\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">(4)\u7279\u5b9a\u306e\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u3001\u533b\u7642\u8a18\u9332\u7b49\u306e\u5143\u306e\u533b\u7642\u60c5\u5831\u307e\u3067\u9061\u3063\u3066\u691c\u8a3c\u3059\u308b\u3053\u3068\u306f\u3001\u305d\u308c\u304c\u671b\u307e\u3057\u3044\u5834\u5408\u3067\u3042\u3063\u3066\u3082\u4e0d\u53ef\u80fd\u3067\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u3053\u306e\u3088\u3046\u306a\u554f\u984c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\u306f2023\u5e745\u6708\u306b\u6539\u6b63\u3055\u308c\u3001\u5f8c\u306b\u300c\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u300d\u3068\u540d\u4ed8\u3051\u3089\u308c\u308b\u30c7\u30fc\u30bf\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u65b0\u305f\u306b\u8ffd\u52a0\u3055\u308c\u307e\u3057\u305f\u3002\u6539\u6b63\u6cd5\u306f\u516c\u5e03\u304b\u30891\u5e74\u4ee5\u5185\u3001\u3064\u307e\u308a2024\u5e745\u6708\u307e\u3067\u306b\u65bd\u884c\u3055\u308c\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u3068\u306f\u3001\u4ed6\u306e\u60c5\u5831\u3068\u7167\u5408\u3057\u306a\u3044\u9650\u308a\u500b\u4eba\u3092\u7279\u5b9a\u3067\u304d\u306a\u3044\u3088\u3046\u306b\u51e6\u7406\u3055\u308c\u305f\u30c7\u30fc\u30bf\u3092\u3044\u3044\u307e\u3059\u3002\u3053\u306e\u65b0\u3057\u3044\u30c7\u30fc\u30bf\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5206\u985e\u3055\u308c\u308b\u305f\u3081\u306b\u3001\u500b\u4eba\u533b\u7642\u60c5\u5831\u304b\u3089\u56fa\u6709\u306e\u30c7\u30fc\u30bf\u3092\u524a\u9664\u3059\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305f\u3060\u3057\u3001\u6c0f\u540d\u3084\u305d\u306e\u4ed6\u306e\u8b58\u5225\u60c5\u5831\u306f\u524a\u9664\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\"><strong>\u6539\u6b63\u6cd5\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u4ed5\u7d44\u307f\u304c\u78ba\u7acb\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n<p style=\"text-align: justify;\">\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u3092\u4f5c\u6210\u30fb\u63d0\u4f9b\u3059\u308b\u4e8b\u696d\u8005\u3092\u8a8d\u5b9a\u3057\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u4e8b\u696d\u8005\u304c\u3001\u5b89\u5168\u7ba1\u7406\u7b49\u306e\u57fa\u6e96\u306b\u57fa\u3065\u304d\u653f\u5e9c\u306b\u3088\u3063\u3066\u8a8d\u5b9a\u3055\u308c\u305f\u5229\u7528\u8005\u306b\u5bfe\u3057\u3066\u306e\u307f\u3001\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u7b2c1\u306e\u4ed5\u7d44\u307f\u306f\u3001\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u3092\u4f5c\u6210\u30fb\u63d0\u4f9b\u3067\u304d\u308b\u4e8b\u696d\u8005\u3092\u653f\u5e9c\u304c\u8a8d\u5b9a\u3059\u308b\u3068\u3044\u3046\u3082\u306e\u3067\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u306e\u4ed5\u7d44\u307f\u3068\u5171\u901a\u306e\u69cb\u9020\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002\u4e00\u65b9\u3001\u7b2c2\u306e\u4ed5\u7d44\u307f\u306f\u3001\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u7279\u6709\u306e\u3082\u306e\u3067\u3059\u3002<\/p>\n<p style=\"text-align: justify;\">\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u306f\u3001\u533f\u540d\u5316\u3055\u308c\u305f\u533b\u7642\u30c7\u30fc\u30bf\u3088\u308a\u3082\u500b\u4eba\u3092\u7279\u5b9a\u3067\u304d\u308b\u30ea\u30b9\u30af\u304c\u9ad8\u3044\u305f\u3081\u3001\u653f\u5e9c\u306e\u8a8d\u8a3c\u306b\u3088\u308a\u5229\u7528\u8005\u3082\u5236\u9650\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306e\u305f\u3081\u306b\u3001\u8a8d\u8a3c\u3055\u308c\u305f\u5229\u7528\u8005\u306f\u3001\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u304a\u3088\u3073\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u306e\u4ed5\u7d44\u307f\u3092\u63a1\u7528\u3059\u308b\u5916\u56fd\u306e\u898f\u5236\u5f53\u5c40\u3092\u542b\u3080\u4ed6\u306e\u898f\u5236\u5f53\u5c40\u306b\u3001\u4eee\u540d\u5316\u533b\u7642\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u8a8d\u8a3c\u3055\u308c\u305f\u4e8b\u696d\u8005\u306f\u5f53\u5c40\u306b\u5143\u306e\u30c7\u30fc\u30bf\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"vantage-orange\"><strong>\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u985e\u4f3c\u6cd5\u4ee4<\/strong><\/span><\/h2>\n<figure id=\"attachment_469498\" aria-describedby=\"caption-attachment-469498\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"wp-image-469500 size-full\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2024\/02\/Takuya-Izumi.jpg\" alt=\"Takuya Izumi\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-469498\" class=\"wp-caption-text\"><b> \u6cc9 \u5353\u4e5f<\/b><br \/>\u56fd\u969b\u4e8b\u696d\u90e8\u9577<br \/>\u5f01\u7406\u58eb<br \/>\u6749\u6751\u842c\u56fd\u7279\u8a31\u6cd5\u5f8b\u4e8b\u52d9\u6240<br \/>\u6771\u4eac<br \/>\u96fb\u5b50\u30e1\u30fc\u30eb\uff1a<a href=\"mailto:t.izumi@sugimura.partners\">t.izumi@sugimura.partners<\/a><\/figcaption><\/figure>\n<p style=\"text-align: justify;\">\u6539\u6b63\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\u306b\u306f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u304c\u63d0\u6848\u3057\u3066\u3044\u308b\u6b27\u5dde\u533b\u7642\u30c7\u30fc\u30bf\u30b9\u30da\u30fc\u30b9\uff08\u4ee5\u4e0b\u300cEHDS\u300d\u3068\u3044\u3044\u307e\u3059\uff09\u3068\u5171\u901a\u70b9\u304c\u3042\u308b\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002EHDS\u306f\u533b\u7642\u30c7\u30fc\u30bf\u306e\u4e00\u6b21\u5229\u7528\u304a\u3088\u3073\u4e8c\u6b21\u5229\u7528\u3092\u898f\u5236\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u6ce8\uff1a<\/p>\n<p style=\"text-align: justify;\">\u4e00\u6b21\u5229\u7528\u3068\u306f\u3001\u30c7\u30fc\u30bf\u4e3b\u4f53\u306b\u3088\u308b\u5229\u7528\u3092\u6307\u3057\u3001\u60a3\u8005\u304c\u533b\u7642\u8a18\u9332\u3001\u51e6\u65b9\u7b8b\u304a\u3088\u3073\u691c\u67fb\u7d50\u679c\u3092EU\u52a0\u76df\u56fd\u9593\u3067\u4e92\u63db\u6027\u306e\u3042\u308b\u96fb\u5b50\u30c7\u30fc\u30bf\u3068\u3057\u3066\u4fdd\u6301\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u4e8c\u6b21\u5229\u7528\u3068\u306f\u3001\u7814\u7a76\u958b\u767a\u3084\u653f\u7b56\u7acb\u6848\u306a\u3069\u3067\u306e\u5229\u7528\u3092\u6307\u3057\u307e\u3059\u3002<\/p>\n<p style=\"text-align: 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