{"id":6255,"date":"2018-03-03T05:34:53","date_gmt":"2018-03-02T20:34:53","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=fszblog&#038;p=6255"},"modified":"2025-11-12T20:45:16","modified_gmt":"2025-11-12T11:45:16","slug":"pharmaceutical10","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=pharmaceutical10","title":{"rendered":"FDA\uff5c\u533b\u85ac\u54c1\u6d41\u901a\uff08GDP\uff09\u306e\u6587\u66f8\u8a18\u9332\u306e\u6a19\u6e96\u5316\u624b\u9806"},"content":{"rendered":"<p>Standardization of Data and Documentation Practices for Product Tracing<br \/>\nMarch 2018<\/p>\n<p>\u300c\u533b\u85ac\u54c1\u306e\u6d41\u901a\u6642\u306e\u8ffd\u8de1\u306e\u7528\u306edata\u3068\u6587\u66f8\u5316(\u8a18\u9332)\u306e\u6a19\u6e96\u5316\u624b\u9806\u300d\u3068\u984c\u3055\u308c\u308b\u3001FDA\u306eGDP\u306b\u95a2\u9023\u3059\u308bguide\u306edraft\u304c3\u67081\u65e5\u306b\u767a\u51fa\u3055\u308c\u305f\u3002<br \/>\n\u3053\u306edraft\u3078\u306ecomment\u306f\u30014\u6708\u672b\u307e\u3067\u306bFDA\u306b\u9001\u4ed8\u3059\u308b\u3053\u3068\u3002<\/p>\n<p>\u25a0\u524d\u66f8\u304d<br \/>\n\u3053\u306eguide\u306e\u4e3b\u65e8\u30fb\u76ee\u7684\u3092\u3001FDA\u306f\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u300c\u7b2c582\u6761\u306e\u533b\u85ac\u54c1\u8ffd\u8de1\u8981\u4ef6\u304c\u30012015\u5e741\u670827\u65e5\u3088\u308a\u524d\u306b\u533b\u85ac\u54c1\u6d41\u901a\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u5165\u3063\u305f\u533b\u85ac\u85ac\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u300d\u3092\u3001\u793a\u3059\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>\u3053\u306e\u5bfe\u8c61\u306b\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u306b\u8f38\u51fa\u3055\u308c\u308b\u533b\u85ac\u54c1\u3082\u542b\u307e\u308c\u308b\u3053\u3068\u306b\u306a\u308b\u305f\u3081\u3001\u56fd\u5185\u306e\u533b\u85ac\u4f01\u696d\u3001\u8f38\u51fa\u5546\u793e\u306b\u3082\u95a2\u9023\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u7c21\u5358\u306b\u307e\u3068\u3081\u3066\u307f\u305f\u3002<\/p>\n<p>\u25a0\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u7bc4\u56f2<br \/>\n\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001FD\uff06C\u6cd5\u7b2c582\u6761\u306e\u8981\u4ef6\u306b\u57fa\u3065\u3044\u3066\u3001\u6b21\u306e\u6240\u6709\u8005\u3001FDA\u3001\u307e\u305f\u306f\u4ed6\u306e\u9069\u5207\u306a\u5dde\u307e\u305f\u306f\u9023\u90a6\u5f53\u5c40\u8005\u306b\u6355\u6349\u3055\u308c\u3001\u7dad\u6301\u3055\u308c\u3001\u63d0\u4f9b\u3055\u308c\u308b\u533b\u85ac\u54c1\u8ffd\u8de1\u60c5\u5831\u3092\u6307\u3059\u3002<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u53d6\u308a\u6271\u8005(\u6d41\u901a\u696d\u8005)\u304c\u3001\u6b21\u306e\u53d6\u308a\u6271\u8005(\u6d41\u901a\u696d\u8005)\u306b\u9023\u7d61\u3059\u3079\u304d\u533b\u85ac\u54c1\u30c8\u30ec\u30fc\u30b9\u60c5\u5831\u3001\u305d\u306e\u60c5\u5831\u306b\u542b\u3081\u308b\u3079\u304d\u30c7\u30fc\u30bf\u8981\u7d20\u3092\u4f8b\u793a\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>\u307e\u305f\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u6d41\u901a\u696d\u8005\u304c\u7b2c582\u6761\u306e\u533b\u85ac\u54c1\u30c8\u30ec\u30fc\u30b9\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u4f7f\u7528\u3067\u304d\u308b\u6587\u66f8\u3092\u6a19\u6e96\u5316\u3059\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u63a8\u5968\u4e8b\u9805\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u53d6\u5f15\u60c5\u5831\u3001\u53d6\u5f15\u5c65\u6b74\u3001\u53d6\u5f15\u660e\u7d30\u306e\u76f8\u4e92\u4ea4\u63db\u304c\u5bb9\u6613\u306b\u306a\u308b\u3068\u3053\u3068\u3092\u671f\u5f85\u3057\u3066\u3044\u308b\u3002<\/p>\n<p>\u7b2c582\u6761\u306b\u5f93\u3063\u305f\u533b\u85ac\u54c1\u306e\u6d41\u901a\u4e0a\u306e\u60c5\u5831\u3068\u306f\u3001<\/p>\n<div class=\"s_table\"><table>\n<tbody>\n<tr>\n<td width=\"213\">A. Standardizing the Transaction Information<\/td>\n<td width=\"212\">A.\u53d6\u5f15\u60c5\u5831\u306e\u6a19\u6e96\u5316<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">1. Proprietary or Established Name of the Product<\/td>\n<td width=\"212\">1.\u533b\u85ac\u54c1\u306e\u6240\u6709\u8005\u307e\u305f\u306f\u767b\u9332\u3055\u308c\u305f\u540d\u79f0<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">2. Strength and Dosage Form of the Product<\/td>\n<td width=\"212\">2.\u533b\u85ac\u54c1\u306e\u529b\u4fa1\u3068\u5264\u578b<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">3. National Drug Code Number of the Product.<\/td>\n<td width=\"212\">3.\u533b\u85ac\u54c1\u306eNDC\u756a\u53f7<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">4. Container Size<\/td>\n<td width=\"212\">4.\u5bb9\u5668(\u5305\u88c5\uff09\u306e\u30b5\u30a4\u30ba<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">5. Number of Containers8<\/td>\n<td width=\"212\">5.\u5bb9\u5668(\u5305\u88c5\uff09\u306e\u6570<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">6. Lot Number of the Product<\/td>\n<td width=\"212\">6.\u533b\u85ac\u54c1\u306e\u30ed\u30c3\u30c8\u756a\u53f7<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">7. Date of the Transaction<\/td>\n<td width=\"212\">7.\u53d6\u5f15\u65e5<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">8. Date of the Shipment, If More Than 24 Hours After the Date of the Transaction<\/td>\n<td width=\"212\">8.\u53d6\u5f15\u65e5\u3088\u308a24\u6642\u9593\u4ee5\u4e0a\u7d4c\u904e\u3057\u305f\u5834\u5408\u306e\u51fa\u8377\u65e5<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">9. Business Name and Address of the Person From Whom Ownership Is Being Transferred<\/td>\n<td width=\"212\">9.\u6240\u6709\u6a29\u3092\u8b72\u6e21\u30fb\u79fb\u52d5\u3059\u308b\uff1b\u4e8b\u696d\u8005\u540d\u304a\u3088\u3073\u4f4f\u6240<\/td>\n<\/tr>\n<tr>\n<td width=\"213\">10. Business Name and Address of the Person to Whom Ownership Is Being Transferred<\/td>\n<td width=\"212\">10.\u6240\u6709\u6a29\u3092\u8b72\u6e21\u3055\u308c\u308b\u4e8b\u696d\u8005\u540d\u3068\u4f4f\u6240<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u25a0\u305d\u306e\u60c5\u5831\u306e\u8aac\u660e<\/p>\n<ol>\n<li>\u533b\u85ac\u54c1\u306e\u6240\u6709\u8005\u307e\u305f\u306f\u767b\u9332\u3055\u308c\u305f\u540d\u79f0<\/li>\n<\/ol>\n<p>\u5546\u7528\u306b\u5c0e\u5165\u3055\u308c\u305f\u533b\u85ac\u54c1\u306e\u6700\u521d\u306e\u53d6\u5f15\u60c5\u5831\u3092\u4f5c\u6210\u3057\u3066\u3044\u308b\u88fd\u9020\u696d\u8005\u307e\u305f\u306f\u518d\u5305\u88c5\u696d\u8005\u306f\u3001\u533b\u85ac\u54c1\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u6240\u6709\u540d\u307e\u305f\u306f\u767b\u9332\u3055\u308c\u305f\u540d\u524d\u3092\u3001\u7d9a\u304f\u8cfc\u5165\u8005\u306b\u63d0\u4f9b\u3059\u308b\u53d6\u5f15\u60c5\u5831\u306b\u4f7f\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u7d9a\u304f\u53d6\u5f15\u5148\u306f\u3001\u533b\u85ac\u54c1\u306e\u524d\u306e\u6240\u6709\u8005\u304b\u3089\u53d7\u3051\u53d6\u3063\u305f\u53d6\u5f15\u60c5\u5831\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u540d\u524d\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3002<\/p>\n<ol start=\"2\">\n<li>\u533b\u85ac\u54c1\u306e\u542b\u91cf\u30fb\u529b\u4fa1\u3068\u5264\u578b<\/li>\n<\/ol>\n<p>\u5f7c\u3089\u304c\u5546\u696d\u5316\u306b\u5c0e\u5165\u3057\u3066\u3044\u308b\u533b\u85ac\u54c1\u306e\u6700\u521d\u306e\u53d6\u5f15\u60c5\u5831\u3092\u4f5c\u6210\u3057\u3066\u3044\u308b\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u518d\u5305\u88c5\u696d\u8005\u306f\u3001\u7d9a\u304f\u8cfc\u5165\u8005\u306b\u63d0\u4f9b\u3059\u308b\u53d6\u5f15\u60c5\u5831\u306e\u533b\u85ac\u54c1\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u533b\u85ac\u54c1\u306e\u529b\u4fa1\u304a\u3088\u3073\u5264\u5f62\u3092\u4f7f\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u542b\u91cf\u30fb\u529b\u4fa1<\/li>\n<\/ul>\n<p>\u53d6\u5f15\u60c5\u5831\u306b\u542b\u307e\u308c\u308b\u533b\u85ac\u54c1\u306e\u529b\u4fa1\u306b\u306f\u3001\u5404API\u306e\u542b\u91cf\u3068\u305d\u308c\u306b\u5bfe\u5fdc\u3059\u308b\u6e2c\u5b9a\u5358\u4f4d\uff08\u4f8b\uff1a500 mg\uff09\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5264\u5f62<\/li>\n<\/ul>\n<p>\u5264\u578b\u306f\u3001\u305d\u306e\u7269\u7406\u7684\u5f62\u614b\uff08\u4f8b\u3048\u3070\u3001\u9320\u5264\u3001\u30ab\u30d7\u30bb\u30eb\u3001\u6eb6\u6db2\u307e\u305f\u306f\u7c89\u672b\uff09\u306e\u533b\u85ac\u54c1\u3092\u540c\u5b9a\u3059\u308b\u3053\u3068\u3002\u7565\u8a9e\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001\u5c11\u306a\u304f\u3068\u30823\u6587\u5b57\u3067\u69cb\u6210\u3059\u308b\u3053\u3068\u3002<\/p>\n<ol start=\"3\">\n<li>\u533b\u85ac\u54c1\u306e\u30ca\u30b7\u30e7\u30ca\u30eb\u30fb\u30c9\u30e9\u30c3\u30b0\u30fb\u30b3\u30fc\u30c9\u756a\u53f7<\/li>\n<\/ol>\n<p>\u30ca\u30b7\u30e7\u30ca\u30eb\u30c9\u30e9\u30c3\u30b0\u30b3\u30fc\u30c9\uff08NDC\uff09\u306f\u3001\u30e9\u30d9\u30e9\u30fc\u30b3\u30fc\u30c9\u3001\u88fd\u54c1\u30b3\u30fc\u30c9\u3001\u304a\u3088\u3073\u30d1\u30c3\u30b1\u30fc\u30b8\u30b3\u30fc\u30c9\u3067\u69cb\u6210\u3055\u308c\u308b3\u30bb\u30b0\u30e1\u30f3\u30c8\u756a\u53f7\u3002<\/p>\n<ol start=\"4\">\n<li>\u5bb9\u5668\u306e\u30b5\u30a4\u30ba<\/li>\n<\/ol>\n<p>\u5bb9\u5668\u306e\u5927\u304d\u3055\u306f\u3001\u7bb1\u3001\u30b1\u30fc\u30b9\u3001\u30c8\u30fc\u30c8\u306a\u3069\u306e\u3088\u308a\u5927\u304d\u306a\u7269\u54c1\u306e\u51fa\u8377\u5358\u4f4d\u3067\u306f\u306a\u304f\u3001\u300c\u500b\u3005\u306e\u8ca9\u58f2\u53ef\u80fd\u306a\u5358\u4f4d\u300d\u306e\u5305\u88c5\u69cb\u6210\u3092\u53cd\u6620\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 \u5bb9\u5668\u30b5\u30a4\u30ba\u306f\u3001\u5bb9\u5668\u5f53\u305f\u308a\u306e\u5264\u306e\u6570\u3067\u3042\u308b\u3002<\/p>\n<ol start=\"5\">\n<li>\u5bb9\u5668(\u5305\u88c5\uff09\u306e\u6570<\/li>\n<\/ol>\n<p>\u5bb9\u5668(\u5305\u88c5\uff09\u306e\u6570\u306f\u3001\u53d6\u5f15\u306b\u542b\u307e\u308c\u308b\u540c\u3058\u30ed\u30c3\u30c8\u756a\u53f7\u306e\u533b\u85ac\u54c1\u306e\u500b\u3005\u306e\u8ca9\u58f2\u53ef\u80fd\u306a\u5358\u4f4d\u306e\u6570\u91cf\u3002<\/p>\n<ol start=\"6\">\n<li>\u533b\u85ac\u54c1\u306e\u30ed\u30c3\u30c8\u756a\u53f7<\/li>\n<\/ol>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u76ee\u7684\u4e0a\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u306f\u3001\u88fd\u9020\u696d\u8005\u307e\u305f\u306f\u518d\u5305\u88c5\u696d\u8005\u304c\u30d0\u30c3\u30c1\u3001\u307e\u305f\u306f\u30d0\u30c3\u30c1\u306e\u7279\u5b9a\u306e\u7279\u5b9a\u90e8\u5206\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306b\u5272\u308a\u5f53\u3066\u3089\u308c\u305f\u82f1\u6570\u5b57\u306e\u96c6\u5408\u3067\u3042\u308a\u3001\u7279\u5b9a\u306e\u9650\u5ea6\u5185\u3067\u4e00\u69d8\u306a\u6027\u8cea\u304a\u3088\u3073\u54c1\u8cea\u3092\u6709\u3059\u308b\u533b\u85ac\u54c1\u3092\u793a\u3059\u3002<\/p>\n<ol start=\"7\">\n<li>\u53d6\u5f15\u65e5<\/li>\n<\/ol>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u76ee\u7684\u4e0a\u3001\u53d6\u5f15\u65e5\u306f\u3001\u53d6\u5f15\u306b\u95a2\u4e0e\u3059\u308b\u533b\u85ac\u54c1\u306e\u6240\u6709\u6a29\u304c\u53d6\u5f15\u5148\u9593\u3067\u79fb\u8ee2\u3055\u308c\u305f\u65e5\u3002<\/p>\n<ol start=\"8\">\n<li>\u53d6\u5f15\u65e5\u3088\u308a24\u6642\u9593\u4ee5\u4e0a\u7d4c\u904e\u3057\u305f\u5834\u5408\u306e\u51fa\u8377\u65e5<\/li>\n<\/ol>\n<p>\u51fa\u8377\u65e5\u306b\u306f\u3001\u533b\u85ac\u54c1\u3092\u53d7\u9818\u3059\u308b\u53d6\u308a\u6271\u8005(\u6d41\u901a\u696d\u8005)\u306b\u51fa\u8377\u3055\u308c\u305f\u65e5\u4ed8\u304c\u53cd\u6620\u3055\u308c\u307e\u3059\u3002<\/p>\n<ol start=\"9\">\n<li>\u6240\u6709\u6a29\u3092\u8b72\u6e21\u30fb\u79fb\u52d5\u3059\u308b\uff1b\u4e8b\u696d\u8005\u540d\u304a\u3088\u3073\u4f4f\u6240<\/li>\n<\/ol>\n<p>FDA\u306f\u3001\u533b\u85ac\u54c1\u306e\u6240\u6709\u6a29\u3092\u79fb\u8ee2\u3059\u308b\u6d41\u901a\u696d\u8005\u304c\u3001\u53d6\u5f15\u60c5\u5831\u306b\u3069\u306e\u4f4f\u6240\u3092\u63d0\u4f9b\u3059\u308b\u304b\uff08\u4f8b\u3048\u3070\u3001\u672c\u793e\u307e\u305f\u306f\u4f1a\u793e\u306e\u4f4f\u6240\u3001\u8acb\u6c42\u5148\u4f4f\u6240\u3001\u914d\u9001\u5148\u4f4f\u6240\uff09\u306b\u95a2\u3059\u308b\u8907\u6570\u306e\u9078\u629e\u80a2\u3092\u6709\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3002<\/p>\n<ol start=\"10\">\n<li>\u6240\u6709\u6a29\u3092\u8b72\u6e21\u3055\u308c\u308b\u4e8b\u696d\u8005\u540d\u3068\u4f4f\u6240<\/li>\n<\/ol>\n<p>FDA\u306f\u3001\u6240\u6709\u6a29\u304c\u79fb\u8ee2\u3055\u308c\u3066\u3044\u308b\u6d41\u901a\u696d\u8005\u306f\u3001\u53d6\u5f15\u60c5\u5831\u306b\u3069\u306e\u4f4f\u6240\u3092\u63d0\u4f9b\u3059\u308b\u304b\uff08\u4f8b\u3048\u3070\u3001\u672c\u793e\u307e\u305f\u306f\u4f1a\u793e\u306e\u4f4f\u6240\u3001\u8acb\u6c42\u5148\u4f4f\u6240\u3001\u914d\u9001\u5148\u4f4f\u6240\uff09\u306b\u95a2\u3059\u308b\u8907\u6570\u306e\u9078\u629e\u80a2\u3092\u6301\u3064\u3053\u3068\u3002<\/p>\n<p>B.\u53d6\u5f15\u5c65\u6b74\u306e\u6a19\u6e96\u5316<\/p>\n<p>\u5404\u53d6\u5f15\u306b\u3064\u3044\u3066\u3001\u53d6\u5f15\u60c5\u5831\u306f\u53d6\u5f15\u5c65\u6b74\u3068\u306f\u5225\u306b\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 \u53d6\u5f15\u5c65\u6b74\u306f\u3001FD\uff06C\u6cd5\u306e\u30bb\u30af\u30b7\u30e7\u30f3581\uff0825\uff09\u306b\u304a\u3044\u3066\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u5143\u306b\u8fd4\u9001\u3055\u308c\u308b\u5404\u524d\u53d6\u5f15\u306e\u53d6\u5f15\u60c5\u5831\u3092\u542b\u3080\u3001\u7d19\u5f62\u5f0f\u307e\u305f\u306f\u96fb\u5b50\u5f62\u5f0f\u306e\u660e\u7d30\u66f8\u3068\u3057\u3066\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u3002 \u4e00\u822c\u306b\u3001\u533b\u85ac\u54c1\u306e\u30c8\u30e9\u30f3\u30b6\u30af\u30b7\u30e7\u30f3\u5c65\u6b74\u306f\u3001\u305d\u306e\u533b\u85ac\u54c1\u306b\u95a2\u9023\u3059\u308b\u305d\u308c\u305e\u308c\u306e\u305d\u308c\u307e\u3067\u306e\u30c8\u30e9\u30f3\u30b6\u30af\u30b7\u30e7\u30f3\u306e\u30c8\u30e9\u30f3\u30b6\u30af\u30b7\u30e7\u30f3\u60c5\u5831\u306e\u96c6\u8a08\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<p>\u3055\u3089\u306bFDA\u304c\u5f37\u8abf\u3057\u3066\u3044\u308b\u3053\u3068\u306f\u3001\u300cC.\u53d6\u5f15\u660e\u7d30\u66f8\u306e\u6a19\u6e96\u5316\u300d\uff1b\u3002<\/p>\n<p>FD\uff06C\u6cd5\u306e\u30bb\u30af\u30b7\u30e7\u30f3582\uff08b\uff09\uff081\uff09\u3001\uff08c\uff09\uff081\uff09\u3001\uff08d\uff09\uff081\uff09\u3001\u304a\u3088\u3073\uff08e\uff09\uff081\uff09\u306b\u5f93\u3063\u3066\u3001\u53d6\u308a\u6271\u8005(\u6d41\u901a\u696d\u8005)\u306f\u3001\u53d6\u5f15\u524d\u307e\u305f\u306f\u53d6\u5f15\u6642\u70b9\u3067\u306e\u53d6\u5f15\u660e\u7d30\u66f8\u3002\u6d41\u901a\u696d\u8005\u306f\u3001\u3053\u306e\u53d6\u5f15\u660e\u7d30\u66f8\u306e\u4ea4\u63db\u6642\u306b\u4e0b\u8a18\u306e\u63a8\u5968\u4e8b\u9805\u306b\u5f93\u3046\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<p>1.\u53d6\u5f15\u660e\u7d30\u66f8<\/p>\n<p>\u53d6\u5f15\u660e\u7d30\u66f8\u306f\u3001FD\uff06C\u6cd5\u306e\u30bb\u30af\u30b7\u30e7\u30f3581\uff0827\uff09\u3067\u6b21\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u3002<\/p>\n<p>\u7d19\u307e\u305f\u306f\u96fb\u5b50\u5f62\u5f0f\u3067\u3001\u4f01\u696d\u304c\u53d6\u5f15\u3067\u6240\u6709\u6a29\u3092\u79fb\u8ee2\u3059\u308b\u3053\u3068\u3002<\/p>\n<p>\uff08A\uff09\u306f\u3001\u533b\u85ac\u54c1\u4f9b\u7d66\u9023\u9396\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u6cd5\u306b\u57fa\u3065\u304d\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u8a8d\u53ef\u3055\u308c\u3066\u3044\u308b\u3002<\/p>\n<p>\uff08B\uff09Drug Supply Chain Security Act\u306e\u4e0b\u3067\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u627f\u8a8d\u3055\u308c\u305f\u8005\u304b\u3089\u533b\u85ac\u54c1\u3092\u53d7\u3051\u53d6\u3063\u305f\u3002<\/p>\n<p>\uff08C\uff09\u30bb\u30af\u30b7\u30e7\u30f3582\u3067\u8981\u6c42\u3055\u308c\u308b\u3088\u3046\u306b\u3001\u533b\u85ac\u54c1\u306e\u524d\u6240\u6709\u8005\u304b\u3089\u53d6\u5f15\u60c5\u5831\u3068\u53d6\u5f15\u660e\u7d30\u66f8\u3092\u53d7\u3051\u53d6\u3063\u305f\u3002<\/p>\n<p>\uff08D\uff09\u4e0d\u5be9\u306a\u307e\u305f\u306f\u9055\u6cd5\u306a\u533b\u85ac\u54c1\u3092\u610f\u56f3\u7684\u306b\u51fa\u8377\u3057\u3066\u3044\u306a\u3044\u3002<\/p>\n<p>\uff08E\uff09\u30bb\u30af\u30b7\u30e7\u30f3582\u306b\u57fa\u3065\u304f\u691c\u8a3c\u8981\u4ef6\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u3068\u30d7\u30ed\u30bb\u30b9\u3092\u6709\u3057\u3066\u3044\u305f\u3002<\/p>\n<p>\uff08F\uff09\u610f\u56f3\u7684\u306b\u8aa4\u3063\u305f\u53d6\u5f15\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u306a\u304b\u3063\u305f\u3002<\/p>\n<p>\uff08G\uff09\u53d6\u5f15\u5c65\u6b74\u3092\u6545\u610f\u306b\u5909\u66f4\u3057\u306a\u304b\u3063\u305f\u3002<\/p>\n<p>\u3053\u308c\u3089\u3092\u3001\u96fb\u5b50\u7684\u82e5\u3057\u304f\u306f\u7269\u7406\u7684(\u7d19\u306b\u8a18\u9332)\u306b\u3001\u8a18\u9332\u30fb\u4fdd\u7ba1\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u308b\u3002<\/p>\n<p>\u4ee5\u4e0a<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-drugs-gen\/documents\/document\/ucm598734.pdf\">https:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-drugs-gen\/documents\/document\/ucm598734.pdf<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-6255","news","type-news","status-publish","hentry","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/6255","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=6255"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=6255"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}