{"id":263,"date":"2023-07-06T11:59:02","date_gmt":"2023-07-06T03:59:02","guid":{"rendered":"https:\/\/consulting-hmk.com\/products\/simple-ways-to-protect-our-planet-copy-6\/"},"modified":"2024-02-20T14:13:02","modified_gmt":"2024-02-20T06:13:02","slug":"drug-consulting","status":"publish","type":"products","link":"https:\/\/www.consulting-hmk.com\/ja\/products\/%e3%83%89%e3%83%a9%e3%83%83%e3%82%b0%e3%82%b3%e3%83%b3%e3%82%b5%e3%83%ab%e3%83%86%e3%82%a3%e3%83%b3%e3%82%b0\/","title":{"rendered":"NMPA\u85ac\u54c1\u767b\u9332"},"content":{"rendered":"

\u00a0 \u00a0 \u00a0 \u539f\u6750\u6599\u85ac\u54c1\uff08\u4ee5\u4e0b\u306fAPIs\u3068\u7565\u3059\u308b\uff09\u3068\u85ac\u54c1\u5305\u88c5\u6750\u6599\u306e\u767b\u9332\u8005\u306f\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u85ac\u54c1\u5be9\u67fb\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\uff08\u4ee5\u4e0b\u306fCDE\u3092\u7565\u3059\u308b\uff09\u3067\u767b\u9332\u3057\u3001\u4e14\u3064\u95a2\u9023\u8cc7\u6599\u306e\u63d0\u51fa\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n

\u00a0 \u00a0 \u00a0 \u539f\u6750\u6599\u85ac\u54c1\uff08\u4ee5\u4e0b\u306fAPIs\u3068\u7565\u3059\u308b\uff09\u3068\u85ac\u54c1\u5305\u88c5\u6750\u6599\u306e\u767b\u9332\u8005\u306f\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u85ac\u54c1\u5be9\u67fb\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\uff08\u4ee5\u4e0b\u306fCDE\u3068\u7565\u3059\u308b\uff09\u306e\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u95a2\u9023\u8cc7\u6599\u306e\u767b\u9332\u3068\u63d0\u51fa\u3092\u884c\u3063\u305f\u5f8c\u3067\u3001\u5f62\u5f0f\u5be9\u67fb\u306b\u9069\u3057\u305f\u85ac\u7528\u88dc\u52a9\u6750\u6599\u3068\u85ac\u54c1\u5305\u88c5\u6750\u6599\u306f\u300cI\u72b6\u614b\u306e\u767b\u9332\u756a\u53f7\u300d\u3092\u53d6\u5f97\u3057\u3001\u88fd\u5264\u95a2\u9023\u5be9\u67fb\u8a55\u4fa1\u306e\u969b\u306b\u6280\u8853\u5be9\u67fb\u3092\u7d4c\u3066\u304b\u3089\u3001\u767b\u9332\u72b6\u614b\u306f\u300cI\u300d\u304b\u3089\u300cA\u300d\u306b\u5909\u308f\u308a\u307e\u3059\u3002CDE\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u4e0a\u3067\u767b\u9332\u756a\u53f7\u3001\u88fd\u54c1\u540d\u79f0\u3001\u4f01\u696d\u540d\u79f0\u3068\u751f\u7523\u4f4f\u6240\u7b49\u306e\u57fa\u672c\u60c5\u5831\u304c\u516c\u793a\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n

\u00a0 \u00a0 \u00a0 \u56fd\u5185\u751f\u7523\u30e1\u30fc\u30ab\u30fc\u306f\u767b\u9332\u8005\u3068\u3057\u3066\u6240\u6709\u306e\u3059\u3079\u3066\u306e\u88fd\u54c1\u306b\u5bfe\u3057\u3001\u81ea\u4e3b\u767b\u9332\u3092\u3059\u3079\u304d\u3067\u3059\u3002 <\/span><\/p>\n

\u00a0 \u00a0 \u00a0 \u56fd\u5916\u751f\u7523\u30e1\u30fc\u30ab\u30fc\u306f\u4e2d\u56fd\u4ee3\u7406\u6a5f\u95a2\u306b\u767b\u9332\u696d\u52d9\u3092\u59d4\u8a17\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n

\u85ac\u54c1\u767b\u9332\u3068\u5c4a\u3051\u51fa\u306e\u6cd5\u5f8b\u6cd5\u898f\u306e\u6839\u62e0<\/span><\/strong><\/span><\/h2>\n
    \n
  • \u300a\u4e2d\u83ef\u4eba\u6c11\u5171\u548c\u56fd\u85ac\u54c1\u7ba1\u7406\u65b9\u6cd5\u300b<\/span><\/li>\n
  • \u300a\u4e2d\u83ef\u4eba\u6c11\u5171\u548c\u56fd\u85ac\u54c1\u7ba1\u7406\u65b9\u6cd5\u300b<\/span><\/li>\n
  • \u300a\u4e2d\u83ef\u4eba\u6c11\u5171\u548c\u56fd\u85ac\u54c1\u7ba1\u7406\u65b9\u6cd5\u300b<\/span><\/li>\n
  • \u300a\u7dcf\u5c40\u306f\u539f\u6750\u6599\u85ac\u3001\u85ac\u7528\u88dc\u52a9\u6750\u6599\u3068\u85ac\u5305\u6750\u5be9\u67fb\u8a55\u4fa1\u3001\u627f\u8a8d\u8a31\u53ef\u4e8b\u9805\u306b\u95a2\u3057\u3066\u8abf\u6574\u3059\u308b\u516c\u544a <\/span>\uff082017\u5e74\u7b2c146\u53f7\uff09\u300b <\/span><\/li>\n
  • \u300a\u56fd\u5bb6\u85ac\u76e3\u5c40\u306f\u66f4\u306b\u85ac\u54c1\u95a2\u9023\u5be9\u67fb\u8a55\u4fa1\u3001\u627f\u8a8d\u8a31\u53ef\u3068\u76e3\u7763\u7ba1\u7406\u95a2\u9023\u4e8b\u9805\u306b\u95a2\u3057\u3066\u5b8c\u5099\u3059\u308b\u516c\u544a <\/span>\uff082019\u5e74\u7b2c56\u53f7\uff09\u300b\u7b49\u3002<\/span><\/li>\n<\/ul>\n

    \u85ac\u54c1\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9<\/span><\/strong><\/span><\/h2>\n

    \u00a0 \u00a0 \u00a0 HMK\u306f\u6570\u793e\u306e\u88fd\u85ac\u4f1a\u793e\u306b\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u4e2d\u56fd\u5e02\u5834\u30ed\u30fc\u30f3\u30c1\u306e\u305f\u3081\u306e\u5be9\u67fb\u3001\u85ac\u54c1\u30de\u30b9\u30bf\u30fc\u767b\u9332\u8a8d\u8a3c\uff08DMF\uff09\u3001\u4e2d\u56fd\u826f\u597d\u751f\u7523\u898f\u7bc4\uff08GMP\uff09\u306e\u5dee\u7570\u5206\u6790\u3001CMC\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u3001\u305d\u306e\u4ed6\u8cea\u91cf\u3068\u76e3\u7763\u7ba1\u7406\u7b49\u3092\u542b\u307e\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u4e2d\u56fd\u56fd\u5185\u306e\u6cd5\u5b9a\u4ee3\u7406\u4eba\u30b5\u30fc\u30d3\u30b9\u3082\u63d0\u4f9b\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n
    \u30b5\u30fc\u30d3\u30b9\u5185\u5bb9<\/b><\/strong><\/span><\/td>\n<\/tr>\n
    \u7533\u8acb\u8cc7\u6599\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3001\u5dee\u7570\u5206\u6790\u3092\u884c\u3063\u305f\u4e0a\u3067\u54c1\u8cea\u60c5\u5831\u306e\u4eee\u5be9\u67fb\u3068\u7d50\u5408\u3057\u3001 <\/span><\/p>\n

    \u8cc7\u6599\u5185\u5bb9\u3092\u5b8c\u5099\u3055\u305b\u308b\u3088\u3046\u306b\u6307\u5c0e\u3059\u308b<\/span><\/td>\n<\/tr>\n

    \u5916\u56fd\u8a9e\u306e\u8cc7\u6599\u7ffb\u8a33\u3001\u6821\u95b2<\/span><\/td>\n<\/tr>\n
    \u7533\u8acb\u8cc7\u6599\u306e\u7de8\u6210\u3001\u6574\u7406\u3068\u63d0\u51fa\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001<\/span><\/p>\n

    \u8a3c\u62e0\u8cc7\u6599\u3068\u66f8\u985e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306e\u4f5c\u6210\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b<\/span><\/td>\n<\/tr>\n

    CDE\u7533\u8acb\u306e\u9032\u6357\u72b6\u6cc1\u3092\u968f\u6642\u30d5\u30a9\u30ed\u30fc\u3059\u308b<\/span><\/td>\n<\/tr>\n
    \u6280\u8853\u5be9\u67fb\u904e\u7a0b\u306b\u304a\u3051\u308b\u8cc7\u6599\u6539\u6b63\/\u8ffd\u52a0\u4f5c\u6210\u53ca\u3073\u66f8\u985e\u63d0\u51fa<\/span><\/td>\n<\/tr>\n
    \u767b\u9332\u691c\u8a3c\u7528\u30b5\u30f3\u30d7\u30eb\u54c1\u306e\u901a\u95a2\u624b\u7d9a\u304d\u3001\u904b\u9001\uff06\u4fdd\u5b58\uff1b <\/span><\/p>\n

    \u30b5\u30f3\u30d7\u30eb\u63d0\u51fa\u3001\u691c\u8a3c\u30d5\u30a9\u30ed\u30fc\u3068\u8cea\u7591\u5fdc\u7b54\u306a\u3069\u306e\u554f\u3044\u5408\u308f\u305b\u5bfe\u5fdc<\/span><\/td>\n<\/tr>\n

    \u767b\u9332\u8cc7\u6599\u5185\u5bb9\u306e\u5909\u66f4\u306a\u3069\uff08\u91cd\u5927\u3001\u4e2d\u3001\u5fae\u53ca\u3073\u57fa\u790e\u60c5\u5831\u5909\u66f4\u306a\u3069\u5404\u30ec\u30d9\u30eb\u3092\u542b\u3080\uff09\u3068\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9<\/span><\/td>\n<\/tr>\n
    \u5e74\u6b21\u5831\u544a\u66f8\u306e\u63d0\u51fa<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

    \u539f\u6750\u6599\u3001\u88dc\u52a9\u6750\u6599\u3001\u5305\u6750\u767b\u9332\u8cc7\u6599\u53ca\u3073\u5be9\u67fb\u30d5\u30ed\u30fc<\/span><\/strong><\/span><\/h2>\n

    \u00a0 \u00a0 \u00a0 \u300c\u539f\u88dc\u5305\u300d\u306e\u82f1\u8a9e\u7701\u7565\u8868\u8a18\u306fAEP\u3067\u3001\u85ac\u539f\u6750\u6599\u3001\u85ac\u88dc\u52a9\u6750\u6599\u3001\u76f4\u63a5\u85ac\u54c1\u3068\u63a5\u89e6\u3059\u308b\u5305\u88c5\u6750\u6599\u3068\u5bb9\u5668\u306e\u7dcf\u79f0\u3067\u3059\u3002\u00a0\u00a0<\/span><\/p>\n

    \u00a0 \u00a0 \u00a0 \u4e0b\u8a18\u306e\u8868\u306f\u5316\u5b66\u85ac\u54c1\u3068\u751f\u7269\u88fd\u54c1\u306e\u7533\u8acb\u30d5\u30ed\u30fc\u3068\u306a\u308a\u307e\u3059\u3002\u66f4\u306b\u8a73\u3057\u3044\u60c5\u5831\u3092\u77e5\u308a\u305f\u3044\u5834\u5408\u3001\u304a\u6c17\u8efd\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n

    \"\u85ac\u54c1\"<\/span><\/p>\n

    \u304a\u554f\u3044\u5408\u308f\u305b<\/span><\/strong><\/span><\/h2>\n

    \u00a0 \u00a0 \u00a0 \u3042\u306a\u305f\u6216\u3044\u306f\u8cb4\u793e\u306f\u73fe\u5728\u4e0b\u8a18\u306e\u60a9\u307f\u3092\u6301\u3063\u3066\u3044\u308c\u3070\u3001\u305c\u3072\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span><\/p>\n

      \n
    • \u7533\u8acb\u4e2d\u306e\u88fd\u85ac\u4f01\u696d\u3067NMPA\u304b\u3089\u88dc\u8db3\u901a\u77e5\u66f8\u304c\u5c4a\u304d\u30012\u56de\u76ee\u306e\u6280\u8853\u5be9\u67fb\u306e\u66f8\u985e\u3092\u6e96\u5099\u3057\u3066\u3044\u308b\u3068\u3053\u308d\u3067\u3059<\/span><\/li>\n
    • \u691c\u67fb\u30b5\u30f3\u30d7\u30eb\u3092\u4e2d\u56fd\u306e\u8a66\u9a13\u6a5f\u95a2\u306b\u90f5\u9001\u3057\u305f\u3044\u306e\u3067\u3059\u304c\u3001\u901a\u95a2\u624b\u7d9a\u304d\u306f\u3069\u3046\u3059\u308c\u3070\u3044\u3044\u304b\u5206\u304b\u308a\u307e\u305b\u3093<\/span><\/li>\n
    • \u4e2d\u56fd\u3067\u884c\u3046\u5fc5\u8981\u306e\u3042\u308b\u691c\u67fb\u9805\u76ee\u306f\u78ba\u5b9a\u3067\u304d\u307e\u305b\u3093<\/span><\/li>\n
    • \u9069\u3057\u3066\u3044\u308b\u691c\u67fb\u30c6\u30b9\u30c8\u6a5f\u95a2\u304c\u898b\u3064\u304b\u308a\u307e\u305b\u3093<\/span><\/li>\n
    • \u88fd\u54c1\u304c\u4e2d\u56fd\u306b\u304a\u3051\u308b\u767b\u9332\u671f\u9593\u3092\u77e5\u308a\u305f\u3044\u3067\u3059<\/span><\/li>\n
    • \u4e2d\u56fd\u3067\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u306e\u3042\u308b\u66f8\u985e\u306e\u7a2e\u985e\u3092\u77e5\u308a\u305f\u3044\u3067\u3059<\/span><\/li>\n
    • \u4e2d\u56fd\u85ac\u54c1\u5e02\u5834\u306e\u95a2\u9023\u60c5\u5831\u3092\u77e5\u308a\u305f\u3044\u3067\u3059<\/span><\/li>\n
    • NMPA\u4ee3\u7406\u4eba\u3092\u3069\u3046\u9078\u3079\u3070\u3044\u3044\u304b\u3001\u5206\u304b\u308a\u307e\u305b\u3093<\/span><\/li>\n
    • \u88fd\u54c1\u6210\u5206\u306f\u4e2d\u56fd\u57fa\u6e96\u306b\u9069\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3001\u78ba\u5b9a\u3067\u304d\u307e\u305b\u3093<\/span><\/li>\n
    • \u8a00\u8449\u3068\u6587\u5316\u306e\u5dee\u7570\u3084\u5730\u57df\u5236\u9650\u7b49\u306e\u8981\u56e0\u3067NMPA\u3068\u30b9\u30e0\u30fc\u30ba\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u53d6\u308c\u306a\u3044\u3053\u3068\u3067\u88fd\u54c1\u306f\u767b\u9332\u3067\u304d\u306a\u3044\u3068\u306e\u60a9\u307f\u3084\u5fc3\u914d\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n
    • \u85ac\u54c1\u5305\u88c5\u6216\u3044\u306f\u88dc\u52a9\u6750\u6599\u306e\u751f\u7523\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u3001\u4e2d\u56fd\u306eDMF\u767b\u9332\u60c5\u5831\u3092\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n
    • \u4e2d\u6587\u306e\u6cd5\u5f8b\u898f\u5b9a\u3092\u65e5\u672c\u8a9e\u306b\u6216\u3044\u306f\u82f1\u8a9e\u306b\u7ffb\u8a33\u3057\u3066\u307b\u3057\u3044\u3067\u3059\u3002<\/span><\/li>\n<\/ul>\n

      \u30b5\u30fc\u30d3\u30b9\u30d5\u30ed\u30fc<\/span><\/strong><\/span><\/p>\n

      Setp 1 \u554f\u3044\u5408\u308f\u305b\u3084\u30cb\u30fc\u30ba\u306e\u9001\u4ed8<\/span><\/strong><\/p>\n

      \u968f\u6642\u554f\u3044\u5408\u308f\u305b\u8868\u3092\u8a18\u5165\u3057\u3001\u30e1\u30fc\u30eb\u6216\u3044\u306f\u96fb\u8a71\u3067\u3054\u9023\u7d61\u304f\u3060\u3055\u3044<\/span><\/p>\n

      Step 2 \u30cb\u30fc\u30ba\u306e\u78ba\u5b9a<\/span><\/strong><\/p>\n

      \u696d\u52d9\u9700\u8981\u3092\u53d7\u3051\u53d6\u3063\u305f\u5f8c\u306b\u3001\u5177\u4f53\u7684\u306a\u8981\u6c42\u306b\u3064\u3044\u3066\u78ba\u8a8d\u3068\u5354\u8b70\u3092\u3057\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u79d8\u5bc6\u4fdd\u6301\u5951\u7d04\u3092\u7de0\u7d50\u3057\u307e\u3059\u3002<\/span><\/p>\n

      Step 3 \u5b9f\u65bd\u6848\u3092\u4f5c\u6210\u3059\u308b<\/span><\/strong><\/p>\n

      Step2\u306b\u57fa\u3065\u304d\u3001\u30b5\u30fc\u30d3\u30b9\u5b9f\u65bd\u6848\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u5bfe\u9762\u4f1a\u8ac7\u6216\u3044\u306f\u96fb\u8a71\u3084\u30e1\u30fc\u30eb\u3092\u901a\u3058\u3066\u3001\u8a73\u7d30\u5185\u5bb9\u3092\u8aac\u660e\u3057\u307e\u3059\u3002<\/span><\/p>\n

      Step 4 \u5951\u7d04\u7de0\u7d50<\/span><\/strong><\/p>\n

      \u59d4\u8a17\u5951\u7d04\u3092\u7de0\u7d50\u3057\u307e\u3059<\/span><\/p>\n

      Step 5 \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u958b\u59cb<\/span><\/strong><\/p>\n

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      Step 6 \u4f5c\u696d\u306e\u9032\u6357\u5831\u544a<\/span><\/strong><\/p>\n

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