{"id":1078,"date":"2024-07-17T14:17:16","date_gmt":"2024-07-17T06:17:16","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=1078"},"modified":"2024-07-17T14:46:50","modified_gmt":"2024-07-17T06:46:50","slug":"summary-of-common-technical-deficiencies-in-api-nmpa-cde-registration","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/summary-of-common-technical-deficiencies-in-api-nmpa-cde-registration\/","title":{"rendered":"API NMPA\/CDE\u767b\u9332\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u6280\u8853\u7684\u6b20\u9665\u306e\u6982\u8981"},"content":{"rendered":"<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u4e2d\u56fd\u306e\u65b0\u653f\u7b56\u304c\u5f90\u3005\u306b\u5b9f\u65bd\u3055\u308c\u3001\u65bd\u884c\u3055\u308c\u3064\u3064\u3042\u308b\u3002 <a href=\"https:\/\/www.samr.gov.cn\/zw\/zfxxgk\/fdzdgknr\/fgs\/art\/2023\/art_3275cb2a929d4c34ac8c0421b2a9c257.html\" rel=\"nofollow noopener\" target=\"_blank\">\u533b\u85ac\u54c1\u884c\u653f\u6cd5<\/a> \u3068\u305d\u306e\u95a2\u9023\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u5236\u5b9a\u3055\u308c\u3001\u533b\u85ac\u54c1\u958b\u767a\u306e\u5168\u904e\u7a0b\u306b\u304a\u3051\u308b\u7814\u7a76\u4f5c\u696d\u306e\u7db2\u7f85\u6027\u304c\u3088\u308a\u5f37\u304f\u6c42\u3081\u3089\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u3002\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306e\u4e2d\u3001\u30d8\u30a2\u30d4\u30f3\u767a\u751f\u4e8b\u4f8b\u3092\u628a\u63e1\u30fb\u5206\u6790\u3057\u305f\u7d50\u679c\u3001\u30d8\u30a2\u30d4\u30f3\u767a\u751f\u306b\u306f\u4e00\u822c\u7684\u306b\u5171\u901a\u3057\u305f\u7279\u5fb4\u304c\u3042\u308b\u3053\u3068\u304c\u308f\u304b\u308a\u307e\u3057\u305f\u3002\u305d\u3053\u3067\u3001\u539f\u85ac\u306eNMPA\u767b\u9332\u306e\u904e\u7a0b\u3067\u8d77\u3053\u308a\u3046\u308b\u30d8\u30a2\u30d4\u30f3\u5185\u5bb9\u3092\u3001\u7533\u544a\u66f8\u306e\u4f5c\u6210\u9806\u306b\u307e\u3068\u3081\u307e\u3057\u305f\u3002(\u306a\u304a\u3001\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306f\u69d8\u3005\u306a\u8981\u56e0\u306b\u5f71\u97ff\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u305f\u3081\u3001\u540c\u3058\u554f\u984c\u3067\u3082\u5be9\u67fb\u3059\u308b\u5148\u751f\u306b\u3088\u3063\u3066\u30b9\u30b1\u30fc\u30eb\u304c\u7570\u306a\u308b\u3053\u3068\u306b\u3054\u7559\u610f\u304f\u3060\u3055\u3044\u3001 <a href=\"https:\/\/www.consulting-hmk.com\/ja\/%e3%82%b3%e3%83%b3%e3%82%bf%e3%82%af%e3%83%88\/\">\u3054\u9023\u7d61\u304f\u3060\u3055\u3044<\/a>.)<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong><b>\u5178\u578b\u7684\u306a\u6b20\u96651\uff1a\u8a8d\u8a3c\u6587\u66f8\u304c\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u306a\u3044<\/b><\/strong><\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u8f38\u5165\u539f\u85ac\u306e\u6d77\u5916\u627f\u8a8d\u30ea\u30b9\u30c8\u8a3c\u660e\u66f8\u3001GMP\u9069\u5408\u8a3c\u660e\u66f8\u3092\u63d0\u51fa\u3057\u3066\u3044\u306a\u3044\u3001\u307e\u305f\u306f\u8a3c\u660e\u66f8\u985e\u306b\u4e0d\u5099\u304c\u3042\u308b\u3002\u516c\u8a3c\u6e08\u307f\u8a3c\u660e\u66f8\u3001\u8a3c\u660e\u66f8\u306e\u6709\u52b9\u671f\u9650\u5207\u308c\u3001\u4f4f\u6240\u60c5\u5831\u306e\u4e0d\u4e00\u81f4\u306a\u3069\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong>\u4e00\u822c\u8981\u4ef6<\/strong>: <\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u8a3c\u660e\u66f8\u306b\u306f\u4ee5\u4e0b\u306e\u7d44\u307f\u5408\u308f\u305b\u304c\u3042\u308b\uff1a<\/span><\/p>\n<ol>\n<li style=\"list-style-type: none;\">\n<ol style=\"list-style-type: lower-alpha;\">\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">WHO\u30d5\u30a9\u30fc\u30de\u30c3\u30c8CPP<\/span><\/li>\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">\u975eWHO\u30d5\u30a9\u30fc\u30de\u30c3\u30c8 CPP + GMP\uff08\u516c\u8a3c\u6e08\u307f\u8a3c\u660e\u66f8\uff09<\/span><\/li>\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">CEP+GMP\uff08\u516c\u8a3c\u6e08\u307f\u8a3c\u660e\u66f8\uff09<\/span><\/li>\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">FSC + GMP\uff08\u516c\u8a3c\u6e08\u307f\u8a8d\u8a3c\uff09<\/span><\/li>\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">\u539f\u85ac\u306eDMF\u756a\u53f7\uff0b\u539f\u85ac\u3092\u7528\u3044\u3066\u88fd\u9020\u3055\u308c\u305f\u88fd\u5264\u306eGMP\uff0bCPP\uff08\u516c\u8a3c\u3055\u308c\u305f\u8a3c\u660e\u66f8\uff09<\/span><\/li>\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">GMP\uff0fISO9000\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u6587\u66f8\u3078\u306e\u6e96\u62e0\uff0b\u8ca9\u58f2\u8a31\u53ef\u8a3c\uff08\u98df\u54c1\u3068\u3057\u3066\u7ba1\u7406\u3055\u308c\u308b\u5916\u56fd\u5316\u5b66\u539f\u85ac\u306b\u9650\u308b\u3002\uff09<\/span><\/li>\n<li><span style=\"font-size: 12pt; font-family: arial, helvetica, sans-serif;\">\u305d\u306e\u4ed6\u306e\u8cc7\u6599<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u6ce8\u610f\u3059\u3079\u304d\u70b9CPP\u306f\u7d19\u5a92\u4f53\u304b\u96fb\u5b50\u5a92\u4f53\u304b\uff1f\u7d19\u306e\u539f\u672c\u3067\u3042\u308a\u3001WHO\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3084\u305d\u306e\u4ed6\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u516c\u8a3c\u306e\u5fc5\u8981\u306f\u306a\u3044\u3002GMP\u306f\u516c\u8a3c\u3068\u8a8d\u8a3c\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\u4e00\u90e8\u306eCPP\u306fGMP\u60c5\u5831\u3092\u542b\u3093\u3067\u304a\u308a\u3001GMP\u8a3c\u660e\u66f8\u306a\u3057\u3067\u63d0\u51fa\u53ef\u80fd\u3067\u3042\u308b\u304c\u3001CPP\u304c\u65e2\u306bGMP\u95a2\u9023\u60c5\u5831\u3092\u542b\u3093\u3067\u3044\u308b\u3053\u3068\u3092\u660e\u8a18\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u5178\u578b\u7684\u306a\u6b20\u96652\uff1a\u51fa\u767a\u539f\u6599\u306e\u9078\u629e\u306b\u5341\u5206\u306a\u6839\u62e0\u304c\u306a\u3044\u3001\u7533\u544a\u3055\u308c\u305f\u30eb\u30fc\u30c8\u304c\u77ed\u3059\u304e\u308b\u54c1\u7a2e\u304c\u3042\u308b\u3001\u51fa\u767a\u539f\u6599\u306e\u9078\u629e\u304c\u4e0d\u5408\u7406\u3067\u3042\u308b\u3002<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong>\u4e00\u822c\u8981\u4ef6<\/strong>: <\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u7533\u8acb\u8005\u306f\u3001\u539f\u85ac\u304b\u3089\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3092\u5b8c\u5168\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u3092\u8003\u616e\u3057\u3001ICH Q11\u53ca\u3073EU\u306e\u95a2\u9023\u3059\u308b\u6280\u8853\u7684\u8981\u6c42\u4e8b\u9805\u3092\u53c2\u7167\u3057\u3066\u51fa\u767a\u539f\u6599\u3092\u5408\u7406\u7684\u306b\u9078\u629e\u3057\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u7406\u89e3\u3068\u7d44\u307f\u5408\u308f\u305b\u3066GMP\u6761\u4ef6\u4e0b\u3067\u306e\u88fd\u9020\u5de5\u7a0b\u3092\u5408\u7406\u7684\u306b\u6c7a\u5b9a\u3057\u3001\u51fa\u767a\u539f\u6599\u306e\u9078\u629e\u306b\u95a2\u3059\u308b\u95a2\u9023\u3059\u308b\u88cf\u4ed8\u3051\u3068\u306a\u308b\u7814\u7a76\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3057\u3001\u533b\u85ac\u54c1\u5be9\u67fb\u6a5f\u95a2\u3068\u306e\u5408\u610f\u306b\u9054\u3059\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u540c\u3058\u51fa\u767a\u539f\u6599\u306e\u88fd\u9020\u696d\u8005\u304c\u8907\u6570\u3042\u308b\u5834\u5408\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u63a1\u7528\u3059\u308b\u8abf\u88fd\u5de5\u7a0b\u306b\u5408\u308f\u305b\u3066\u3001\u5bfe\u5fdc\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u8981\u4ef6\u3092\u7b56\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u5ba3\u8a00\u3055\u308c\u305f\u5de5\u7a0b\u306f\u3001\u5b89\u5168\u6027\u53c8\u306f\uff0f\u53ca\u3073\u6709\u52b9\u6027\u306b\u91cd\u5927\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u5168\u3066\u306e\u5408\u6210\u5de5\u7a0b\u3092\u7db2\u7f85\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u4f8b\u3048\u3070\u3001\u907a\u4f1d\u6bd2\u6027\u7269\u8cea\u306e\u4f7f\u7528\u3084\u30b9\u30c6\u30c3\u30d7\u306e\u751f\u6210\u306f\u3001\u539f\u85ac\u30b9\u30c6\u30c3\u30d7\u306e\u7acb\u4f53\u5316\u5b66\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3002\u8907\u96d1\u306a\u5316\u5b66\u5408\u6210\u306e\u51fa\u767a\u539f\u6599\u306f\u3001\u305d\u306e\u4f9b\u7d66\u6e90\u3001\u7269\u7406\u5316\u5b66\u7684\u6027\u8cea\u53ca\u3073\u88fd\u9020\u5de5\u7a0b\u7b49\u3068\u7d44\u307f\u5408\u308f \u305b\u3066\u3001\u5408\u7406\u7684\u306a\u51fa\u767a\u539f\u6599\u306e\u54c1\u8cea\u57fa\u6e96\u3092\u7b56\u5b9a\u3057\u3001\u4f9b\u7d66\u8005\u304c\u63d0\u4f9b\u3059\u308b\u5b9f\u969b\u306e\u5de5\u7a0b\u306b\u95a2\u3059\u308b \u60c5\u5831\u3068\u7d44\u307f\u5408\u308f\u305b\u3066\u4f9b\u7d66\u8005\u76e3\u67fb\u5831\u544a\u66f8\u3092\u63d0\u4f9b\u3057\u3001\u88fd\u9020\u5de5\u7a0b\u3067\u5c0e\u5165\u3055\u308c\u308b\u6709\u6bd2\u306a\u8a66\u85ac\/\u6eb6\u5a92\u7b49\u3092\u660e \u3089\u304b\u306b\u3057\u3001\u4e0d\u7d14\u7269\u306e\u5206\u6790\u53ca\u3073\u7ba1\u7406\u3092\u3055\u3089\u306b\u5f37\u5316\u3059\u3079\u304d\u3067\u3042\u308b\u3002 \u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u5178\u578b\u7684\u306a\u6b20\u96653\uff1a\u69cb\u9020\u78ba\u8a8d\u7814\u7a76\u304c\u4e0d\u5341\u5206\u3067\u3001\u5316\u5408\u7269\u306e\u69cb\u9020\u3092\u8a3c\u660e\u3059\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3002<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong>\u4e00\u822c\u8981\u4ef6\uff1a<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u4e00\u90e8\u306e\u8f38\u5165\u539f\u85ac\u306f\u69cb\u9020\u78ba\u8a8d\u304c\u7c21\u7d20\u3067\u3001IR\u3001NMR\uff081H NMR 13C NMR\uff09\u3001\u8cea\u91cf\u5206\u6790\u3001PXRD\u306e\u307f\u3067\u3042\u308b\u3053\u3068\u304c\u591a\u304f\u3001\u5143\u7d20\u5206\u6790\uff08\u307e\u305f\u306f\u504f\u5dee\u306e\u5927\u304d\u3044\u69cb\u9020\u306e\u5143\u7d20\u5206\u6790\uff09\u3001\u71b1\u5206\u6790\u3001\u304a\u3088\u3073\u7acb\u4f53\u914d\u7f6e\u3068\u7279\u5b9a\u306e\u7d50\u6676\u7814\u7a76\u60c5\u5831\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u3002\u6d77\u5916\u306b\u4e0a\u5834\u3055\u308c\u3001\u4e2d\u56fd\u306b\u4e0a\u5834\u3055\u308c\u3066\u3044\u306a\u3044\u5316\u5b66\u533b\u85ac\u54c1\u306e\u533b\u85ac\u54c1\u306e\u7814\u7a76\u53ca\u3073\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u6280\u8853\u7684\u8981\u4ef6\u306b\u95a2\u3059\u308b\u901a\u9054\uff08\u8a66\u884c\u5b9f\u65bd\u7528\uff09\uff082021\u5e74\u7b2c21\u53f7\uff09\u306b\u3088\u308b\u3068\u3001\u7533\u8acb\u8005\u306f\u3001\u30d7\u30ed\u30bb\u30b9\u30eb\u30fc\u30c8\u3068\u69d8\u3005\u306a\u5206\u6790\u8a66\u9a13\u6cd5\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u539f\u85ac\u306e\u5316\u5b66\u69cb\u9020\u3092\u7dcf\u5408\u7684\u306b\u5206\u6790\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u7acb\u4f53\u914d\u7f6e\u3001\u591a\u7d50\u6676\u578b\u3001\u6676\u6790\u6c34\u53ca\u3073\uff0f\u53c8\u306f\u6676\u6790\u6eb6\u5a92\u7b49\u306e\u7d44\u307f\u5408\u308f\u305b\u306e\u53ef\u80fd\u6027\u304c\u3042\u308b\u539f\u85ac\u306b\u3064\u3044\u3066\u306f\u3001\u69cb\u9020\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u9069\u5207\u306a\u5206\u6790\u8a66\u9a13\u6cd5\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"font-size: 14pt; 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font-family: arial, helvetica, sans-serif;\">\u5178\u578b\u7684\u306a\u6b20\u96656\uff1a\u539f\u85ac\u306e\u54c1\u8cea\u57fa\u6e96\u306e\u7ba1\u7406\u304c\u4e0d\u5b8c\u5168\u3001\u4e0d\u5408\u7406\u306a\u898f\u5236\u5024\u8a2d\u5b9a\u307e\u305f\u306f\u898f\u5236\u5024\u8a2d\u5b9a\u306e\u6839\u62e0\u304c\u4e0d\u5341\u5206<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong>\u4e00\u822c\u8981\u4ef6\uff1a<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u7533\u8acb\u8005\u306fICH Q6A\u53ca\u3073\u305d\u306e\u4ed6\u306e\u95a2\u9023\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u53c2\u7167\u3057\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u898f\u683c\u3092\u8a2d\u5b9a\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u539f\u85ac\u306e\u30bf\u30a4\u30d7\u306e\u69cb\u9020\u306b\u57fa\u3065\u3044\u3066\u3001\u539f\u85ac\u306e\u54c1\u8cea\u57fa\u6e96\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u4e3b\u8981\u306a\u54c1\u8cea\u5c5e\u6027\u306f\u3001\u4e3b\u306b\u3044\u304f\u3064\u304b\u306e\u539f\u85ac\u306e\u7d50\u6676\u5f62\u72b6\u3001\u5869\u5f62\u6210\u6bd4\u3001\u7c92\u5f84\u53ca\u3073\u7c92\u5ea6\u5206\u5e03\u3001\u95a2\u9023\u7269\u8cea\u3001\u7570\u6027\u4f53\u306e\u4e0d\u7d14\u7269\u306a\u3069\u306e\u5b58\u5728\u306e\u3088\u3046\u306a\u3044\u304f\u3064\u304b\u306e\u7ba1\u7406\u9805\u76ee\u306b\u7279\u5225\u306a\u6ce8\u610f\u3092\u6255\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u9805\u76ee\u3092\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u7533\u8acb\u8005\u306f\u3001\u539f\u85ac\u306e\u54c1\u8cea\u898f\u683c\u306e\u5408\u7406\u7684\u306a\u8a31\u5bb9\u9650\u754c\u306e\u958b\u767a\u306e\u305f\u3081\u306eICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u53c2\u7167\u3057\u3001\u904e\u53bb\u306e\u30d0\u30c3\u30c1\u8a66\u9a13\u30c7\u30fc\u30bf\u306b\u5f93\u3063\u3066\u3001\u54c1\u8cea\u898f\u683c\u306e\u9650\u754c\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u5b89\u5b9a\u6027\u3092\u53c2\u7167\u3057\u306a\u304c\u3089\u3001\u5408\u7406\u7684\u306a\u5206\u6790\u65b9\u6cd5\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306b\u3001\u85ac\u5c40\u65b9\u6cd5\u306e\u6bd4\u8f03\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u6ce8\u5c04\u7528\u539f\u85ac\u306e\u54c1\u8cea\u898f\u683c\u306f\u3001\u4e00\u822c\u7684\u306b\u5fae\u751f\u7269\u5b66\u7684\u9650\u754c\u5024\u53ca\u3073\u7d30\u83cc\u6027\u30a8\u30f3\u30c9\u30c8\u30ad\u30b7\u30f3\u306e\u30c1\u30a7\u30c3 \u30af\u3092\u542b\u3080\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u5178\u578b\u7684\u306a\u6b20\u96657\uff1a\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong>\u4e00\u822c\u8981\u4ef6\uff1a<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u54c1\u8cea\u6a19\u6e96\u7269\u8cea\u3068COA\u306b\u52a0\u3048\u3066\u3001\u542b\u6709\u91cf\u6c7a\u5b9a\u306b\u4f7f\u7528\u3055\u308c\u308b\u4f5c\u696d\u5bfe\u7167\u7269\u8cea\u306f\u3001\u6821\u6b63\u306e\u5272\u308a\u5f53\u3066\u30d7\u30ed \u30bb\u30b9\u3092\u63d0\u4f9b\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\uff1b\u307e\u305f\u306f\u3001\u81ea\u5bb6\u88fd\u306e\u4e0d\u7d14\u7269\u5bfe\u7167\u7269\u8cea\u306f\u3001\u5fc5\u8981\u306a\u69cb\u9020\u78ba\u8a8d\u3092\u53d7\u3051 \u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u5178\u578b\u7684\u306a\u6b20\u96658\uff1a\u5b89\u5b9a\u6027\u8abf\u67fb\u306b\u304a\u3051\u308b\u91cd\u8981\u306a\u691c\u67fb\u9805\u76ee\u306e\u6f0f\u308c<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\"><strong>\u4e00\u822c\u8981\u4ef6\uff1a<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u539f\u85ac\u306e\u767b\u9332\u7533\u8acb\u3092\u884c\u3046\u5834\u5408\u3001\u7533\u8acb\u8005\u306f\u901a\u5e383\u30d0\u30c3\u30c1\u5206\u306e\u30b5\u30f3\u30d7\u30eb6\u30f6\u6708\u52a0\u901f\u8a66\u9a13\u53ca\u30736\u30f6\u6708\u4ee5\u4e0a\u306e\u9577\u671f\u8a66 \u9a13\u5b89\u5b9a\u6027\u8a66\u9a13\u60c5\u5831\uff08\u4ee3\u8868\u7684\u306a\u30c1\u30e3\u30fc\u30c8\u3092\u542b\u3080\uff09\u3092\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u7279\u5b9a\u306e\u7d50\u6676\u6027\u539f\u85ac\u304c\u6307\u5b9a\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u3067\u7d50\u6676\u5f62\u614b\u3092\u691c\u8a0e\u3057\u306a\u304b\u3063\u305f\u5834\u5408\u3001\u30d8\u30a2\u30d5\u30a3\u30eb\u306b\u306a\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">\u53c2\u8003\u6587\u732e<\/span><\/strong><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">[1] \u4e2d\u56fd\u56fd\u5916\u306b\u4e0a\u5834\u3055\u308c\u3001\u4e2d\u56fd\u56fd\u5185\u306b\u4e0a\u5834\u3055\u308c\u3066\u3044\u306a\u3044\u5316\u5b66\u533b\u85ac\u54c1\u306e\u533b\u85ac\u54c1\u306e\u7814\u7a76\u304a\u3088\u3073\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u6280\u8853\u7684\u8981\u4ef6\u306b\u95a2\u3059\u308b\u901a\u9054\uff08\u8a66\u884c\u5b9f\u65bd\u7528\uff09\uff082021\u5e74\u7b2c21\u53f7\uff09\uff08cde.org.cn\uff09<\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">[2] <a href=\"https:\/\/www.cde.org.cn\/main\/news\/viewInfoCommon\/9706a7a9df0842dfe6219890a9ace657\" rel=\"nofollow noopener\" target=\"_blank\">\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u7dcf\u5c40\u85ac\u4e8b\u5be9\u67fb\u30bb\u30f3\u30bf\u30fc\u304c\u767a\u5e03\u3057\u305f\u300c\u9769\u65b0\u7684\u5316\u5b66\u533b\u85ac\u54c1\u306e\u5e02\u8ca9\u524d\u7533\u8acb\u4f1a\u8b70\u306b\u304a\u3051\u308b\u5171\u901a\u85ac\u4e8b\u554f\u984c\u3068\u95a2\u9023\u6280\u8853\u8981\u6c42\u306b\u95a2\u3059\u308b\u901a\u9054\u300d\uff082021\u5e74\u7b2c48\u53f7\uff09<\/a>(cde.org.cn)\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">[3] \u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u85ac\u54c1\u5be9\u67fb\u30bb\u30f3\u30bf\u30fc\u306f\u3001\u300c\u5316\u5b66\u85ac\u54c1\u306e\u9769\u65b0\u7684\u533b\u85ac\u54c1\u306e\u7b2cIII\u76f8\u81e8\u5e8a\u8a66\u9a13\uff08\u8a66\u884c\uff09\u524d\u4f1a\u8b70\u85ac\u5c40\u306e\u85ac\u7406\u5b66\u4e0a\u306e\u5171\u901a\u554f\u984c\u3068\u95a2\u9023\u6280\u8853\u8981\u6c42\u306b\u95a2\u3059\u308b\u901a\u9054\u300d\u3092\u516c\u5e03\u3057\u305f\uff082023\u5e74\u7b2c23\u53f7\uff09(cde.org.cn)<\/span><\/p>\n<p><span style=\"font-size: 14pt; font-family: arial, helvetica, sans-serif;\">[4] <a href=\"https:\/\/www.nmpa.gov.cn\/xxgk\/fgwj\/gzwj\/gzwjyp\/20050318010101201.html\" rel=\"nofollow noopener\" target=\"_blank\">\u5316\u5b66\u533b\u85ac\u54c1\u539f\u85ac\u306e\u8abf\u88fd\u304a\u3088\u3073\u69cb\u9020\u78ba\u8a8d\u8a66\u9a13\u306b\u95a2\u3059\u308b\u6280\u8853\u6307\u91dd<\/a> (cde.org.cn)\u3002<\/span><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>\u4e2d\u56fd\u306e\u65b0\u85ac\u7269\u7ba1\u7406\u6cd5\u3068\u305d\u306e\u95a2\u9023\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u6bb5\u968e\u7684\u306a\u5b9f\u65bd\u30fb\u65bd\u884c\u306b\u4f34\u3044\u3001\u533b\u85ac\u54c1\u958b\u767a\u306e\u5168\u904e\u7a0b\u306b\u95a2\u308f\u308b\u7814\u7a76\u4f5c\u696d\u306e\u5305\u62ec\u6027\u304c\u3088\u308a\u5f37\u304f\u6c42\u3081\u3089\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u3002\u79c1\u305f\u3061\u306f\u3001\u696d\u52d9\u306e\u904e\u7a0b\u3067\u906d\u9047\u3057\u305f\u30d8\u30a2\u30d4\u30f3\u306e\u4e8b\u4f8b\u3092\u7406\u89e3\u3057\u3001\u5206\u6790\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u3053\u306e\u3088\u3046\u306a\u6b20\u9665\u306b\u306f\u4e00\u822c\u7684\u306b\u5171\u901a\u306e\u7279\u5fb4\u304c\u3042\u308b\u3053\u3068\u3092\u767a\u898b\u3057\u307e\u3057\u305f\u3002\u305d\u3053\u3067\u3001\u539f\u85ac\u306eNMPA\u767b\u9332\u306e\u904e\u7a0b\u3067\u8d77\u3053\u308a\u3046\u308b\u30d8\u30a2\u30d4\u30f3\u5185\u5bb9\u3092\u3001\u7533\u544a\u66f8\u306e\u4f5c\u6210\u9806\u306b\u307e\u3068\u3081\u307e\u3057\u305f\u3002(\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306f\u69d8\u3005\u306a\u8981\u56e0\u306b\u5f71\u97ff\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u305f\u3081\u3001\u540c\u3058\u554f\u984c\u3067\u3082[...]\u5834\u5408\u304c\u3042\u308b\u3053\u3068\u306b\u3054\u7559\u610f\u304f\u3060\u3055\u3044\uff09\u3002<\/p>","protected":false},"author":4,"featured_media":1079,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[70,200],"tags":[589,595,596,597],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/1078"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/comments?post=1078"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/1078\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/1079"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=1078"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/categories?post=1078"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/tags?post=1078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}