{"id":6860,"date":"2026-08-25T02:04:59","date_gmt":"2026-08-25T02:04:59","guid":{"rendered":"https:\/\/tsubaki-jp.com\/?p=6860"},"modified":"2026-08-28T10:53:48","modified_gmt":"2026-08-28T10:53:48","slug":"japan-package-insert-revision-instruction-notices-2026-ja","status":"publish","type":"post","link":"https:\/\/tsubaki-jp.com\/ja\/japan-package-insert-revision-instruction-notices-2026-ja\/","title":{"rendered":"\u6dfb\u4ed8\u6587\u66f8\u306f\u3069\u3046\u6539\u8a02\u3055\u308c\u308b\u304b\u2014\u2014\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a\u901a\u77e5\u3068\u3044\u3046\u6bb5\u53d6\u308a"},"content":{"rendered":"<p>\u65e5\u672c\u3067\u306f\u3001\u6dfb\u4ed8\u6587\u66f8\u306f\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306e\u5224\u65ad\u3060\u3051\u3067\u6539\u8a02\u3055\u308c\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002\u591a\u304f\u306e\u5834\u5408\u306e\u8d77\u70b9\u306f\u3001\u539a\u751f\u52b4\u50cd\u7701\u304c\u767a\u51fa\u3059\u308b\u300c<strong>\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a<\/strong>\u300d\u901a\u77e5\u3067\u3042\u308b\u3002\u672c\u7a3f\u3067\u306f\u3001\u8ab0\u304c\u767a\u51fa\u3057\u3001\u305d\u306e\u5f8c\u306b\u4f55\u304c\u8d77\u304d\u308b\u306e\u304b\u30012026\u5e74\u5ea6\u306b\u3053\u308c\u307e\u3067\u767a\u51fa\u3055\u308c\u305f8\u4ef6\u3001\u305d\u3057\u3066\u8cb7\u3044\u624b\u304c\u898b\u843d\u3068\u3057\u3084\u3059\u3044\u300c\u63b2\u8f09\u307e\u3067\u306e\u30bf\u30a4\u30e0\u30e9\u30b0\u300d\u3092\u6574\u7406\u3059\u308b\u3002<\/p>\n\n<h2>\u6539\u8a02\u6307\u793a\u901a\u77e5\u3068\u306f\u4f55\u304b<\/h2>\n\n<p>\u6539\u8a02\u6307\u793a\u901a\u77e5\u306f\u3001\u539a\u751f\u52b4\u50cd\u7701\u304c\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306b\u5bfe\u3057\u3001\u6dfb\u4ed8\u6587\u66f8\u306e\u300c\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u300d\u306e\u6539\u8a02\u3092\u6307\u793a\u3059\u308b\u6587\u66f8\u3067\u3042\u308b\u3002\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u304c\u81ea\u30b5\u30a4\u30c8\u306b\u63b2\u8f09\u3057\u3001\u95a2\u4fc2\u3059\u308b\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306f\u3053\u306e\u901a\u77e5\u306b\u57fa\u3065\u304d\u6dfb\u4ed8\u6587\u66f8\u3092\u6539\u8a02\u3059\u308b\u3002\u901a\u77e5\u306f\u6307\u793a\u3067\u3042\u308a\u3001\u6539\u8a02\u5f8c\u306e\u6dfb\u4ed8\u6587\u66f8\u306f\u305d\u306e\u7d50\u679c\u306b\u3042\u305f\u308b\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--instruction-result\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-instruction-versus-revised-result.webp\" alt=\"Official revision instruction shown separately from the resulting revised package insert.\" class=\"wp-image-6878\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-instruction-versus-revised-result.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-instruction-versus-revised-result-300x200.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-instruction-versus-revised-result-1024x683.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-instruction-versus-revised-result-768x512.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-instruction-versus-revised-result-600x400.webp 600w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n\n<p>\u56de\u53ce\u3068\u306f\u5225\u306e\u5236\u5ea6\u3067\u3042\u308a\u3001\u30a4\u30a8\u30ed\u30fc\u30ec\u30bf\u30fc\u30fb\u30d6\u30eb\u30fc\u30ec\u30bf\u30fc\u3068\u547c\u3070\u308c\u308b\u7dca\u6025\u5b89\u5168\u6027\u60c5\u5831\u3068\u3082\u5225\u3067\u3042\u308b\u3002\u5f8c\u8005\u306b\u3064\u3044\u3066\u306f<a href=\"https:\/\/tsubaki-jp.com\/ja\/%e6%97%a5%e6%9c%ac%e3%81%ae%e5%8c%bb%e8%96%ac%e5%93%81%e5%9b%9e%e5%8f%8e%e3%83%bb%e5%ae%89%e5%85%a8%e6%80%a7%e6%83%85%e5%a0%b1%e3%81%ae%e8%aa%ad%e3%81%bf%e6%96%b9%ef%bc%9apmda%e3%81%ae%e5%9b%9e\/\">\u56de\u53ce\u3068\u5b89\u5168\u6027\u901f\u5831\u306e\u8aad\u307f\u65b9<\/a>\u3067\u5225\u9014\u6271\u3063\u305f\u3002\u6539\u8a02\u6307\u793a\u306f\u65e5\u5e38\u7684\u304b\u3064\u9ad8\u983b\u5ea6\u306e\u30c1\u30e3\u30cd\u30eb\u3067\u3042\u308a\u3001\u6708\u306b\u6570\u56de\u767a\u51fa\u3055\u308c\u3001\u5e02\u5834\u304b\u3089\u88fd\u54c1\u3092\u5f15\u304d\u4e0a\u3052\u308b\u306e\u3067\u306f\u306a\u304f\u6587\u66f8\u3092\u5909\u66f4\u3059\u308b\u3002<\/p>\n\n<h2>2026\u5e74\u5ea6\u306e8\u901a\u77e5<\/h2>\n\n<p>\u4e0b\u8868\u306fPMDA\u304c\u516c\u8868\u3059\u308b2026\u5e74\u5ea6\u4e00\u89a7\u3092\u30012026\u5e748\u670824\u65e5\u6642\u70b9\u3067\u78ba\u8a8d\u3057\u305f\u3046\u3048\u3067\u305d\u306e\u307e\u307e\u518d\u63b2\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u6210\u5206\u540d\u306f\u901a\u77e5\u306e\u8a18\u8f09\u3069\u304a\u308a\u3068\u3057\u305f\u3002\u5404\u6210\u5206\u304c\u4f55\u306b\u7528\u3044\u3089\u308c\u308b\u304b\u306b\u3064\u3044\u3066\u306f\u672c\u7a3f\u3067\u306f\u6271\u308f\u306a\u3044\u3002\u305d\u308c\u306f\u51e6\u65b9\u533b\u5e2b\u306b\u5411\u3051\u3066\u66f8\u304b\u308c\u305f\u6dfb\u4ed8\u6587\u66f8\u306e\u9818\u57df\u3067\u3042\u308b\u3002<\/p>\n\n<table>\n<thead><tr><th>\u901a\u77e5\u65e5<\/th><th>\u901a\u77e5\u756a\u53f7<\/th><th>\u5bfe\u8c61\u6210\u5206\u540d<\/th><\/tr><\/thead>\n<tbody>\n<tr><td>2026\u5e748\u670817\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0817\u7b2c1\u53f7<\/td><td>\u30c9\u30ca\u30cd\u30de\u30d6\uff08\u907a\u4f1d\u5b50\u7d44\u63db\u3048\uff09\u3001\u30ec\u30ab\u30cd\u30de\u30d6\uff08\u907a\u4f1d\u5b50\u7d44\u63db\u3048\uff09<\/td><\/tr>\n<tr><td>2026\u5e748\u67087\u65e5<\/td><td>\u533b\u85ac\u85ac\u5be9\u767a0807\u7b2c1\u53f7\uff0f\u533b\u85ac\u5b89\u767a0807\u7b2c1\u53f7<\/td><td>\u30d3\u30eb\u30c8\u30e9\u30eb\u30bb\u30f3<\/td><\/tr>\n<tr><td>2026\u5e747\u670814\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0714\u7b2c1\u53f7<\/td><td>\u30a8\u30bd\u30e1\u30d7\u30e9\u30be\u30fc\u30eb\u30de\u30b0\u30cd\u30b7\u30a6\u30e0\u6c34\u548c\u7269\u3001\u30aa\u30e1\u30d7\u30e9\u30be\u30fc\u30eb\u3001\u30dc\u30ce\u30d7\u30e9\u30b6\u30f3\u30d5\u30de\u30eb\u9178\u5869\u3001\u30e9\u30d9\u30d7\u30e9\u30be\u30fc\u30eb\u30ca\u30c8\u30ea\u30a6\u30e0\u3001\u30e9\u30f3\u30bd\u30d7\u30e9\u30be\u30fc\u30eb\uff08\u7d4c\u53e3\u5264\uff09\u307b\u304b<\/td><\/tr>\n<tr><td>2026\u5e746\u670830\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0630\u7b2c13\u53f7<\/td><td>\u30bb\u30d5\u30ab\u30da\u30f3\u30d4\u30dc\u30ad\u30b7\u30eb\u5869\u9178\u5869\u6c34\u548c\u7269\uff08\u5c0f\u5150\u7528\u88fd\u5264\uff09\u307b\u304b<\/td><\/tr>\n<tr><td>2026\u5e746\u670816\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0616\u7b2c1\u53f7<\/td><td>\u70ad\u9178\u30ea\u30c1\u30a6\u30e0\u3001\u30ab\u30eb\u30dc\u30ad\u30b7\u30de\u30eb\u30c8\u30fc\u30b9\u7b2c\u4e8c\u9244\u307b\u304b<\/td><\/tr>\n<tr><td>2026\u5e746\u67085\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0605\u7b2c1\u53f7<\/td><td>\u30c9\u30ca\u30cd\u30de\u30d6\uff08\u907a\u4f1d\u5b50\u7d44\u63db\u3048\uff09\u3001\u30ec\u30ab\u30cd\u30de\u30d6\uff08\u907a\u4f1d\u5b50\u7d44\u63db\u3048\uff09<\/td><\/tr>\n<tr><td>2026\u5e745\u670821\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0521\u7b2c1\u53f7<\/td><td>\u30a2\u30d0\u30b3\u30d1\u30f3<\/td><\/tr>\n<tr><td>2026\u5e744\u670821\u65e5<\/td><td>\u533b\u85ac\u5b89\u767a0421\u7b2c1\u53f7<\/td><td>\u30a4\u30f3\u30d5\u30ea\u30ad\u30b7\u30de\u30d6\uff08\u907a\u4f1d\u5b50\u7d44\u63db\u3048\uff09\u307b\u304b<\/td><\/tr>\n<\/tbody>\n<\/table>\n\n<p>\u4e00\u3064\u6307\u6458\u3057\u3066\u304a\u304d\u305f\u3044\u50be\u5411\u304c\u3042\u308b\u3002\u540c\u3058\u4e8c\u6210\u5206\u2014\u2014\u30c9\u30ca\u30cd\u30de\u30d6\u3068\u30ec\u30ab\u30cd\u30de\u30d6\u2014\u2014\u304c\u540c\u4e00\u5e74\u5ea6\u5185\u306b2\u56de\u30016\u67085\u65e5\u30688\u670817\u65e5\u306b\u767b\u5834\u3057\u3066\u3044\u308b\u3002\u6539\u8a02\u6307\u793a\u306f\u300c\u4e00\u5ea6\u51fa\u305b\u3070\u7d42\u308f\u308a\u300d\u306e\u624b\u7d9a\u3067\u306f\u306a\u3044\u3002\u88fd\u9020\u8ca9\u58f2\u5f8c\u306e\u8abf\u67fb\u304c\u7d9a\u304f\u54c1\u76ee\u3067\u306f\u3001\u6587\u66f8\u306f\u6570\u304b\u6708\u306e\u3046\u3061\u306b\u7e70\u308a\u8fd4\u3057\u958b\u304b\u308c\u3046\u308b\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--repeated-revisions\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-repeated-revisions.webp\" alt=\"A medicine safety dossier passing through two revision checkpoints in one review cycle.\" class=\"wp-image-6879\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-repeated-revisions.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-repeated-revisions-300x200.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-repeated-revisions-1024x683.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-repeated-revisions-768x512.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-repeated-revisions-600x400.webp 600w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n\n<h2>\u898b\u843d\u3068\u3055\u308c\u308b\u30bf\u30a4\u30e0\u30e9\u30b0<\/h2>\n\n<p>PMDA\u306f\u81ea\u3089\u306e\u30da\u30fc\u30b8\u306b\u3001\u6539\u8a02\u6307\u793a\u304c\u51fa\u3055\u308c\u3066\u304b\u3089\u540c\u30b5\u30a4\u30c8\u306e\u6dfb\u4ed8\u6587\u66f8\u60c5\u5831\u304c\u6539\u8a02\u3055\u308c\u308b\u307e\u3067\u306b\u306f\u3001\u3042\u308b\u7a0b\u5ea6\u306e\u6642\u9593\u304c\u304b\u304b\u308b\u3068\u660e\u8a18\u3057\u3066\u3044\u308b\u3002\u672c\u7a3f\u3067\u6700\u3082\u5b9f\u52d9\u7684\u306a\u4e00\u6587\u306f\u3053\u3053\u3067\u3042\u308b\u3002\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u898b\u3066\u6dfb\u4ed8\u6587\u66f8\u304c\u5909\u308f\u3063\u3066\u3044\u306a\u304f\u3066\u3082\u3001\u305d\u308c\u306f\u6307\u793a\u304c\u51fa\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u610f\u5473\u3057\u306a\u3044\u3002\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u304c\u8ffd\u3044\u3064\u3044\u3066\u3044\u306a\u3044\u3060\u3051\u304b\u3082\u3057\u308c\u306a\u3044\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--database-time-lag\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-database-update-time-lag.webp\" alt=\"Regulatory notice reaching reviewers before the public package insert database updates.\" class=\"wp-image-6880\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-database-update-time-lag.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-database-update-time-lag-300x200.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-database-update-time-lag-1024x683.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-database-update-time-lag-768x512.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-database-update-time-lag-600x400.webp 600w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n\n<p>\u5b9f\u52d9\u4e0a\u306e\u5e30\u7d50\u306f\u660e\u5feb\u3067\u3042\u308b\u3002<strong>\u901a\u77e5\u65e5\u3092\u57fa\u6e96\u3068\u3057\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u66f4\u65b0\u65e5\u6642\u3092\u57fa\u6e96\u3068\u3057\u306a\u3044\u3002<\/strong>\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u30b9\u30ca\u30c3\u30d7\u30b7\u30e7\u30c3\u30c8\u3067\u4f5c\u696d\u3057\u3066\u3044\u308b\u5378\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u5b9f\u969b\u306e\u7acb\u5834\u304b\u3089\u6570\u9031\u9593\u9045\u308c\u3046\u308b\u3002\u8d8a\u5883\u4f9b\u7d66\u306e\u305f\u3081\u306b\u54c1\u76ee\u6587\u66f8\u3092\u7dad\u6301\u3059\u308b\u7acb\u5834\u3067\u3042\u308c\u3070\u3001\u7a81\u5408\u3059\u3079\u304d\u306f\u6dfb\u4ed8\u6587\u66f8\u4e00\u89a7\u3067\u306f\u306a\u304f\u901a\u77e5\u4e00\u89a7\u3067\u3042\u308b\u3002<\/p>\n\n<h2>\u78ba\u8a8d\u3059\u308b\u9806\u5e8f<\/h2>\n\n<ol>\n<li><strong>\u5e74\u5ea6\u5225\u306e\u901a\u77e5\u4e00\u89a7\u3002<\/strong>PMDA\u306f\u6539\u8a02\u6307\u793a\u3092\u5e74\u5ea6\u5225\u306b\u63b2\u8f09\u3057\u3066\u304a\u308a\u30011998\u5e74\u5ea6\u307e\u3067\u9061\u308c\u308b\u3002\u73fe\u884c\u306f2026\u5e74\u5ea6\u306e\u30da\u30fc\u30b8\u3002<\/li>\n<li><strong>\u6708\u6b21\u306e\u6dfb\u4ed8\u6587\u66f8\u66f4\u65b0\u30da\u30fc\u30b8\u3002<\/strong>PMDA\u306e\u60c5\u5831\u63d0\u4f9b\u30b5\u30a4\u30c8\u306b\u306f\u300c\uff11\u30f6\u6708\u4ee5\u5185\u306b\u66f4\u65b0\u3055\u308c\u305f\u6dfb\u4ed8\u6587\u66f8\u60c5\u5831\u300d\u3068\u3044\u3046\u30da\u30fc\u30b8\u304c\u3042\u308a\u3001\u904e\u53bb\uff11\u9031\u9593\u30fb\u904e\u53bb\uff12\u9031\u9593\u30fb\u904e\u53bb\uff11\u30f6\u6708\u306e\u30b7\u30e7\u30fc\u30c8\u30ab\u30c3\u30c8\u3068\u3001\u300c\u63b2\u8f09\u5206\u300d\u300c\u524a\u9664\u5206\u300d\u306e\u533a\u5206\u304c\u3042\u308b\u3002<\/li>\n<li><strong>\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306f\u5225\u5efa\u3066\u3002<\/strong>\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306b\u5206\u985e\u3055\u308c\u308b\u54c1\u76ee\u306b\u306f\u72ec\u7acb\u3057\u305f\u6539\u8a02\u6307\u793a\u901a\u77e5\u30da\u30fc\u30b8\u304c\u3042\u308a\u3001\u540c\u3058\u304f\u5e74\u5ea6\u5225\u306b\u6574\u7406\u3055\u308c\u3066\u3044\u308b\u3002\u533b\u85ac\u54c1\u306e\u4e00\u89a7\u306b\u306f\u73fe\u308c\u306a\u3044\u3002<\/li>\n<li><strong>\u30e1\u30fc\u30eb\u914d\u4fe1\u3002<\/strong>PMDA\u306fPMDA\u30e1\u30c7\u30a3\u30ca\u30d3\u3068\u3044\u3046\u30e1\u30fc\u30eb\u914d\u4fe1\u30b5\u30fc\u30d3\u30b9\u3092\u904b\u7528\u3057\u3066\u3044\u308b\u3002\u78ba\u8a8d\u6642\u70b9\u3067\u306f\u306a\u304f\u767a\u51fa\u6642\u70b9\u3067\u77e5\u308b\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u306b\u7528\u3044\u308b\u3002<\/li>\n<\/ol>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--four-source-verification\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-four-source-verification.webp\" alt=\"Four regulatory information sources converging into one verified medicine record.\" class=\"wp-image-6881\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-four-source-verification.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-four-source-verification-300x200.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-four-source-verification-1024x683.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-four-source-verification-768x512.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-four-source-verification-600x400.webp 600w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n\n<h2>\u8abf\u9054\u30fb\u8f38\u5165\u306e\u5b9f\u52d9\u306b\u3068\u3063\u3066\u306e\u610f\u5473<\/h2>\n\n<p>\u8a31\u53ef\u3092\u6301\u3064\u5378\u3084\u6d77\u5916\u306e\u8cb7\u3044\u624b\u306b\u3068\u3063\u3066\u3001\u4ee5\u4e0a\u304b\u3089\u5c0e\u304b\u308c\u308b\u7fd2\u6163\u306f\u4e09\u3064\u3042\u308b\u3002\u7b2c\u4e00\u306b\u3001\u4e8b\u6848\u767a\u751f\u6642\u3067\u306f\u306a\u304f\u4e00\u5b9a\u306e\u5468\u671f\u3067\u901a\u77e5\u4e00\u89a7\u3068\u7a81\u5408\u3059\u308b\u3053\u3068\u3002\u7b2c\u4e8c\u306b\u3001\u65e5\u4ed8\u3060\u3051\u3067\u306a\u304f\u901a\u77e5\u756a\u53f7\u3092\u8a18\u9332\u3059\u308b\u3053\u3068\u2014\u2014\u540c\u3058\u65e5\u306b\u8907\u6570\u306e\u901a\u77e5\u304c\u51fa\u308b\u3053\u3068\u304c\u3042\u308b\u305f\u3081\u3067\u3042\u308b\u3002\u7b2c\u4e09\u306b\u3001\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u3092\u72ec\u7acb\u3057\u305f\u60c5\u5831\u7cfb\u7d71\u3068\u3057\u3066\u6271\u3046\u3053\u3068\u3002\u5b9f\u969b\u306b\u72ec\u7acb\u3057\u3066\u3044\u308b\u304b\u3089\u3067\u3042\u308b\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--procurement-reconciliation\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-procurement-reconciliation.webp\" alt=\"Procurement colleagues reconciling medicine revision notices with compliance records.\" class=\"wp-image-6882\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-procurement-reconciliation.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-procurement-reconciliation-300x200.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-procurement-reconciliation-1024x683.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-procurement-reconciliation-768x512.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/package-insert-procurement-reconciliation-600x400.webp 600w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n\n<p>\u672c\u7a3f\u306e\u4e8b\u5b9f\u306f\u539a\u751f\u52b4\u50cd\u7701\u304a\u3088\u3073PMDA\u306e\u516c\u958b\u8cc7\u6599\u306b\u57fa\u3065\u304f\u3002Tsubaki Trading\u306f\u6771\u4eac\u90fd\u77e5\u4e8b\u533b\u85ac\u54c1\u5378\u58f2\u8ca9\u58f2\u696d\u8a31\u53ef\uff08\u7b2c5313250689\u53f7\uff09\u3092\u4fdd\u6709\u3057\u3001\u3053\u308c\u3089\u306e\u898f\u5236\u6587\u66f8\u3092\u65e5\u5e38\u696d\u52d9\u3068\u3057\u3066\u53d6\u308a\u6271\u3063\u3066\u3044\u308b\u3002<\/p>\n\n<h2>FAQ<\/h2>\n\n<p><strong>\u6539\u8a02\u6307\u793a\u901a\u77e5\u306f\u8ab0\u304c\u767a\u51fa\u3059\u308b\u306e\u304b\u3002<\/strong><br>\n\u539a\u751f\u52b4\u50cd\u7701\u304c\u767a\u51fa\u3059\u308b\u3002PMDA\u304c\u81ea\u30b5\u30a4\u30c8\u306b\u63b2\u8f09\u3057\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u304c\u3053\u306e\u901a\u77e5\u306b\u57fa\u3065\u304d\u6dfb\u4ed8\u6587\u66f8\u3092\u6539\u8a02\u3059\u308b\u3002<\/p>\n\n<p><strong>\u6539\u8a02\u6307\u793a\u306f\u56de\u53ce\u3068\u540c\u3058\u304b\u3002<\/strong><br>\n\u7570\u306a\u308b\u3002\u6539\u8a02\u6307\u793a\u306f\u5e02\u5834\u306b\u6d41\u901a\u3057\u7d9a\u3051\u308b\u54c1\u76ee\u306e\u6587\u66f8\u3092\u5909\u66f4\u3059\u308b\u3002\u56de\u53ce\u306f\u88fd\u54c1\u3092\u5e02\u5834\u304b\u3089\u5f15\u304d\u4e0a\u3052\u308b\u3002\u5236\u5ea6\u3082\u63b2\u8f09\u30c1\u30e3\u30cd\u30eb\u3082\u5225\u3067\u3042\u308b\u3002<\/p>\n\n<p><strong>2026\u5e74\u5ea6\u306f\u4f55\u4ef6\u767a\u51fa\u3055\u308c\u305f\u304b\u3002<\/strong><br>\n2026\u5e748\u670824\u65e5\u6642\u70b9\u30678\u4ef6\u30014\u670821\u65e5\u304b\u30898\u670817\u65e5\u307e\u3067\u306e\u65e5\u4ed8\u3067\u3042\u308b\u3002\u4e00\u89a7\u306f\u5e74\u5ea6\u5225\u3067\u3001\u5e74\u5ea6\u5185\u306b\u5897\u3048\u3066\u3044\u304f\u3002<\/p>\n\n<p><strong>\u30b5\u30a4\u30c8\u306e\u6dfb\u4ed8\u6587\u66f8\u304c\u307e\u3060\u65e7\u7248\u306a\u306e\u306f\u306a\u305c\u304b\u3002<\/strong><br>\nPMDA\u306f\u3001\u6539\u8a02\u6307\u793a\u306e\u767a\u51fa\u304b\u3089\u540c\u30b5\u30a4\u30c8\u306e\u6dfb\u4ed8\u6587\u66f8\u60c5\u5831\u306e\u6539\u8a02\u307e\u3067\u306b\u4e00\u5b9a\u306e\u6642\u9593\u3092\u8981\u3059\u308b\u3068\u660e\u8a18\u3057\u3066\u3044\u308b\u3002\u898f\u5236\u5f53\u5c40\u306e\u7acb\u5834\u3092\u793a\u3059\u306e\u306f\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u66f4\u65b0\u65e5\u6642\u3067\u306f\u306a\u304f\u901a\u77e5\u65e5\u3067\u3042\u308b\u3002<\/p>\n\n<p><strong>\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u3082\u540c\u3058\u4e00\u89a7\u304b\u3002<\/strong><br>\n\u5225\u3067\u3042\u308b\u3002\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306fPMDA\u30b5\u30a4\u30c8\u4e0a\u306b\u72ec\u7acb\u3057\u305f\u6539\u8a02\u6307\u793a\u901a\u77e5\u30da\u30fc\u30b8\u3092\u6301\u3061\u3001\u540c\u3058\u304f\u5e74\u5ea6\u5225\u306b\u6574\u7406\u3055\u308c\u3066\u3044\u308b\u3002<\/p>\n\n<h2>References<\/h2>\n<ol>\n<li><a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/revision-of-precautions\/0001.html\" rel=\"noopener\" target=\"_blank\">\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a\u901a\u77e5\uff08\u533b\u85ac\u54c1\uff09<\/a>\uff0fPMDA<\/li>\n<li><a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/revision-of-precautions\/0375.html\" rel=\"noopener\" target=\"_blank\">2026\u5e74\u5ea6\u6307\u793a\u5206<\/a>\uff0fPMDA<\/li>\n<li><a href=\"https:\/\/www.pmda.go.jp\/safety\/info-services\/ctp\/0012.html\" rel=\"noopener\" target=\"_blank\">\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a\u901a\u77e5\uff08\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\uff09<\/a>\uff0fPMDA<\/li>\n<li><a href=\"https:\/\/www.info.pmda.go.jp\/psearch\/tenpulist.jsp\" rel=\"noopener\" target=\"_blank\">\uff11\u30f6\u6708\u4ee5\u5185\u306b\u66f4\u65b0\u3055\u308c\u305f\u6dfb\u4ed8\u6587\u66f8\u60c5\u5831<\/a>\uff0fPMDA\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u60c5\u5831\u63d0\u4f9b\u30db\u30fc\u30e0\u30da\u30fc\u30b8<\/li>\n<li><a href=\"https:\/\/www.pmda.go.jp\/0017.html\" rel=\"noopener\" target=\"_blank\">\u65b0\u7740\u60c5\u5831<\/a>\uff0fPMDA<\/li>\n<\/ol>\n<p><small>\u51fa\u5178\uff1a\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u30db\u30fc\u30e0\u30da\u30fc\u30b8\uff08https:\/\/www.pmda.go.jp\/\uff09\u3092\u52a0\u5de5\u3057\u3066\u4f5c\u6210\u3002<\/small><\/p>\n\n<p><em>\u672c\u7a3f\u306f\u60c5\u5831\u63d0\u4f9b\u3092\u76ee\u7684\u3068\u3057\u3001\u8a3a\u65ad\u30fb\u6cbb\u7642\u30fb\u670d\u85ac\u306b\u95a2\u3059\u308b\u52a9\u8a00\u3067\u306f\u306a\u304f\u3001\u533b\u7642\u7528\u533b\u85ac\u54c1\u306e\u5e83\u544a\u3067\u3082\u3042\u308a\u307e\u305b\u3093\u3002<a href=\"https:\/\/tsubaki-jp.com\/ja\/editorial-policy-ja\/\">\u7de8\u96c6\u65b9\u91dd<\/a>\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002\u60c5\u5831\u57fa\u6e96\u65e5\uff1a2026\u5e748\u670824\u65e5\u3002<\/em><\/p>\n<script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"BlogPosting\",\"headline\":\"\u6dfb\u4ed8\u6587\u66f8\u306f\u3069\u3046\u6539\u8a02\u3055\u308c\u308b\u304b\u2014\u2014\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a\u901a\u77e5\u3068\u3044\u3046\u6bb5\u53d6\u308a\",\"description\":\"\u539a\u751f\u52b4\u50cd\u7701\u304c\u767a\u51fa\u3059\u308b\u300c\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a\u300d\u3068\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306b\u3088\u308b\u6dfb\u4ed8\u6587\u66f8\u6539\u8a02\u30022026\u5e74\u5ea6\u306e8\u901a\u77e5\u3068\u3001\u78ba\u8a8d\u3059\u3079\u304d\u30da\u30fc\u30b8\u3092\u6574\u7406\u3057\u307e\u3059\u3002\",\"datePublished\":\"2026-08-25\",\"dateModified\":\"2026-08-25\",\"inLanguage\":\"ja\",\"articleSection\":\"\u85ac\u4e8b\u30cb\u30e5\u30fc\u30b9\",\"keywords\":\"\u6dfb\u4ed8\u6587\u66f8, \u96fb\u5b50\u6dfb\u6587, PMDA, \u539a\u751f\u52b4\u50cd\u7701, \u5b89\u5168\u5bfe\u7b56\",\"author\":{\"@type\":\"Organization\",\"name\":\"Tsubaki Trading \u7de8\u96c6\u90e8\"},\"publisher\":{\"@type\":\"Organization\",\"name\":\"Tsubaki Trading\"},\"mainEntityOfPage\":{\"@type\":\"WebPage\",\"@id\":\"https:\/\/tsubaki-jp.com\/ja\/japan-package-insert-revision-instruction-notices-2026-ja\/\"},\"citation\":[{\"@type\":\"WebPage\",\"name\":\"\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u306e\u6539\u8a02\u6307\u793a\u901a\u77e5\uff08\u533b\u85ac\u54c1\uff09\",\"url\":\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/revision-of-precautions\/0001.html\"},{\"@type\":\"WebPage\",\"name\":\"2026\u5e74\u5ea6\u6307\u793a\u5206\",\"url\":\"https:\/\/www.pmda.go.jp\/safety\/info-services\/drugs\/calling-attention\/revision-of-precautions\/0375.html\"},{\"@type\":\"WebPage\",\"name\":\"\uff11\u30f6\u6708\u4ee5\u5185\u306b\u66f4\u65b0\u3055\u308c\u305f\u6dfb\u4ed8\u6587\u66f8\u60c5\u5831\",\"url\":\"https:\/\/www.info.pmda.go.jp\/psearch\/tenpulist.jsp\"}]},{\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"\u6539\u8a02\u6307\u793a\u901a\u77e5\u306f\u8ab0\u304c\u767a\u51fa\u3059\u308b\u306e\u304b\u3002\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"\u539a\u751f\u52b4\u50cd\u7701\u304c\u767a\u51fa\u3059\u308b\u3002PMDA\u304c\u81ea\u30b5\u30a4\u30c8\u306b\u63b2\u8f09\u3057\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u304c\u3053\u306e\u901a\u77e5\u306b\u57fa\u3065\u304d\u6dfb\u4ed8\u6587\u66f8\u3092\u6539\u8a02\u3059\u308b\u3002\"}},{\"@type\":\"Question\",\"name\":\"\u6539\u8a02\u6307\u793a\u306f\u56de\u53ce\u3068\u540c\u3058\u304b\u3002\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"\u7570\u306a\u308b\u3002\u6539\u8a02\u6307\u793a\u306f\u5e02\u5834\u306b\u6d41\u901a\u3057\u7d9a\u3051\u308b\u54c1\u76ee\u306e\u6587\u66f8\u3092\u5909\u66f4\u3059\u308b\u3002\u56de\u53ce\u306f\u88fd\u54c1\u3092\u5e02\u5834\u304b\u3089\u5f15\u304d\u4e0a\u3052\u308b\u3002\u5236\u5ea6\u3082\u63b2\u8f09\u30c1\u30e3\u30cd\u30eb\u3082\u5225\u3067\u3042\u308b\u3002\"}},{\"@type\":\"Question\",\"name\":\"2026\u5e74\u5ea6\u306f\u4f55\u4ef6\u767a\u51fa\u3055\u308c\u305f\u304b\u3002\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"2026\u5e748\u670824\u65e5\u6642\u70b9\u30678\u4ef6\u30014\u670821\u65e5\u304b\u30898\u670817\u65e5\u307e\u3067\u306e\u65e5\u4ed8\u3067\u3042\u308b\u3002\u4e00\u89a7\u306f\u5e74\u5ea6\u5225\u3067\u3001\u5e74\u5ea6\u5185\u306b\u5897\u3048\u3066\u3044\u304f\u3002\"}},{\"@type\":\"Question\",\"name\":\"\u30b5\u30a4\u30c8\u306e\u6dfb\u4ed8\u6587\u66f8\u304c\u307e\u3060\u65e7\u7248\u306a\u306e\u306f\u306a\u305c\u304b\u3002\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"PMDA\u306f\u3001\u6539\u8a02\u6307\u793a\u306e\u767a\u51fa\u304b\u3089\u540c\u30b5\u30a4\u30c8\u306e\u6dfb\u4ed8\u6587\u66f8\u60c5\u5831\u306e\u6539\u8a02\u307e\u3067\u306b\u4e00\u5b9a\u306e\u6642\u9593\u3092\u8981\u3059\u308b\u3068\u660e\u8a18\u3057\u3066\u3044\u308b\u3002\u898f\u5236\u5f53\u5c40\u306e\u7acb\u5834\u3092\u793a\u3059\u306e\u306f\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u66f4\u65b0\u65e5\u6642\u3067\u306f\u306a\u304f\u901a\u77e5\u65e5\u3067\u3042\u308b\u3002\"}},{\"@type\":\"Question\",\"name\":\"\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u3082\u540c\u3058\u4e00\u89a7\u304b\u3002\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"\u5225\u3067\u3042\u308b\u3002\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306fPMDA\u30b5\u30a4\u30c8\u4e0a\u306b\u72ec\u7acb\u3057\u305f\u6539\u8a02\u6307\u793a\u901a\u77e5\u30da\u30fc\u30b8\u3092\u6301\u3061\u3001\u540c\u3058\u304f\u5e74\u5ea6\u5225\u306b\u6574\u7406\u3055\u308c\u3066\u3044\u308b\u3002\"}}]}]}<\/script>","protected":false},"excerpt":{"rendered":"<p>\u6539\u8a02\u6307\u793a\u901a\u77e5\u3068\u306f\u4f55\u304b\u30012026\u5e74\u5ea6\u306e8\u4ef6\u3001\u305d\u3057\u3066\u63b2\u8f09\u307e\u3067\u306e\u30bf\u30a4\u30e0\u30e9\u30b0\u306b\u3064\u3044\u3066\u3002<\/p>\n","protected":false},"author":2,"featured_media":6904,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[739],"tags":[],"class_list":["post-6860","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-news-ja"],"_links":{"self":[{"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/posts\/6860","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/comments?post=6860"}],"version-history":[{"count":3,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/posts\/6860\/revisions"}],"predecessor-version":[{"id":6911,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/posts\/6860\/revisions\/6911"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/media\/6904"}],"wp:attachment":[{"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/media?parent=6860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/categories?post=6860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tsubaki-jp.com\/ja\/wp-json\/wp\/v2\/tags?post=6860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}