{"id":478,"date":"2024-09-06T23:44:06","date_gmt":"2024-09-06T14:44:06","guid":{"rendered":"https:\/\/www.hiro-clinic.or.jp\/ed\/?p=478"},"modified":"2025-01-16T10:24:06","modified_gmt":"2025-01-16T01:24:06","slug":"exporting-pharmaceuticals-india-to-eu","status":"publish","type":"post","link":"https:\/\/www.hiro-clinic.or.jp\/ed\/exporting-pharmaceuticals-india-to-eu\/","title":{"rendered":"\u30a4\u30f3\u30c9\u304b\u3089EU\u3078\u306e\u533b\u85ac\u54c1\u8f38\u51fa"},"content":{"rendered":"

\n\"\"
\n<\/a><\/figure>\n<\/div>\n\n\n\n

\u30a4\u30f3\u30c9\u306e\u898f\u5236\u8981\u4ef6<\/h2>\n\n\n\n
    \n
  1. \u8f38\u51fa\u8a31\u53ef<\/strong>: \u30a4\u30f3\u30c9\u306e\u4e2d\u592e\u85ac\u54c1\u6a19\u6e96\u7ba1\u7406\u6a5f\u69cb\uff08CDSCO\uff09<\/strong><\/span>\u304b\u3089\u306e\u8f38\u51fa\u8a31\u53ef\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u88fd\u54c1\u304c\u30a4\u30f3\u30c9\u56fd\u5185\u3067\u306e\u627f\u8a8d\u3092\u53d7\u3051\u3066\u3044\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u88fd\u9020\u65bd\u8a2d\u304c\u9069\u5207\u306a\u88fd\u9020\u5b9f\u8df5\u57fa\u6e96\uff08GMP\uff09\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u8a3c\u660e\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/li>\n\n\n\n
  2. \u54c1\u8cea\u4fdd\u8a3c<\/strong>: \u8f38\u51fa\u3055\u308c\u308b\u85ac\u54c1\u304c\u56fd\u969b\u7684\u306a\u54c1\u8cea\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u54c1\u8cea\u4fdd\u8a3c\u66f8\u985e\uff08Certificate of Analysis, CoA\uff09\u3068GMP\u8a3c\u660e\u66f8\u304c\u5fc5\u8981\u3067\u3059\u3002<\/li>\n<\/ol>\n\n\n
    \n
    \"\"<\/figure><\/div>\n\n\n

    \u30e8\u30fc\u30ed\u30c3\u30d1\u9023\u5408\uff08EU\uff09\u306e\u898f\u5236\u8981\u4ef6<\/h2>\n\n\n\n
      \n
    1. \u533b\u85ac\u54c1\u767b\u9332<\/strong>: EU\u5e02\u5834\u306b\u85ac\u54c1\u3092\u8f38\u5165\u3059\u308b\u306b\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u307e\u305f\u306f\u5404\u52a0\u76df\u56fd\u306e\u5f53\u5c40\u306b\u3088\u308b\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u3001\u5305\u62ec\u7684\u306a\u6587\u66f8\u63d0\u51fa\u3068\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u54c1\u8cea\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/li>\n\n\n\n
    2. \u8f38\u5165\u30e9\u30a4\u30bb\u30f3\u30b9<\/strong>: EU\u52a0\u76df\u56fd\u306b\u3088\u3063\u3066\u306f\u3001\u8f38\u5165\u696d\u8005\u306b\u8f38\u5165\u30e9\u30a4\u30bb\u30f3\u30b9\u304c\u5fc5\u8981\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u8f38\u5165\u696d\u8005\u304c\u9069\u5207\u306a\u8a31\u53ef\u3068\u65bd\u8a2d\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3059\u3002<\/li>\n\n\n\n
    3. GMP\u9075\u5b88<\/strong>: EU\u306f\u8f38\u5165\u3055\u308c\u308b\u85ac\u54c1\u306e\u88fd\u9020\u65bd\u8a2d\u304cEU\u306eGMP\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8981\u6c42\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u901a\u5e38\u3001EU\u5f53\u5c40\u306b\u3088\u308b\u73fe\u5730\u691c\u67fb\u306b\u3088\u3063\u3066\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002<\/li>\n\n\n\n
    4. \u8a3c\u660e\u66f8<\/strong>: EU\u306b\u8f38\u5165\u3059\u308b\u969b\u306b\u306f\u3001\u88fd\u54c1\u306e\u88fd\u9020\u304c\u9069\u5207\u306a\u898f\u5236\u57fa\u6e96\u306b\u5f93\u3063\u3066\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u8f38\u51fa\u56fd\u306e\u898f\u5236\u5f53\u5c40\u304b\u3089\u767a\u884c\u3055\u308c\u305fCertificate of Pharmaceutical Product (CPP)\u304c\u5fc5\u8981\u3067\u3059\u3002<\/li>\n<\/ol>\n\n\n

      \n\"\"
      \n<\/a><\/figure>\n<\/div>\n\n\n\n

      \u30e8\u30fc\u30ed\u30c3\u30d1\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09<\/h2>\n\n\n\n

      \u30e8\u30fc\u30ed\u30c3\u30d1\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u9023\u5408\uff08EU\uff09\u306e\u5168\u52a0\u76df\u56fd\u306b\u5bfe\u3057\u3066\u85ac\u54c1\u306e\u8a55\u4fa1\u3068\u76e3\u8996\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002EMA\u306e\u6d3b\u52d5\u306fEU\u52a0\u76df\u56fd\u3060\u3051\u3067\u306a\u304f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u306e\u56fd\u3005\u306b\u3082\u53ca\u3073\u307e\u3059\u3002EEA\u306fEU\u52a0\u76df\u56fd\u306b\u52a0\u3048\u3066\u3001\u30ce\u30eb\u30a6\u30a7\u30fc\u3001\u30a2\u30a4\u30b9\u30e9\u30f3\u30c9\u3001\u30ea\u30d2\u30c6\u30f3\u30b7\u30e5\u30bf\u30a4\u30f3\u3092\u542b\u3093\u3067\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

      EMA\u304c\u898f\u5236\u3059\u308b\u4e3b\u306a\u56fd\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/p>\n\n\n\n

        \n
      1. EU\u52a0\u76df\u56fd<\/strong>: \u73fe\u5728\uff082024\u5e74\u306e\u6642\u70b9\u3067\uff09\u3001EU\u306b\u306f27\u306e\u52a0\u76df\u56fd\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u5927\u304d\u306a\u7d4c\u6e08\u56fd\u3067\u3042\u308b\u30c9\u30a4\u30c4\u3001\u30d5\u30e9\u30f3\u30b9\u3001\u30a4\u30bf\u30ea\u30a2\u3001\u30b9\u30da\u30a4\u30f3\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/li>\n\n\n\n
      2. EEA\u52a0\u76df\u56fd<\/strong>: EU\u52a0\u76df\u56fd\u306b\u52a0\u3048\u3066\u3001\u30ce\u30eb\u30a6\u30a7\u30fc\u3001\u30a2\u30a4\u30b9\u30e9\u30f3\u30c9\u3001\u30ea\u30d2\u30c6\u30f3\u30b7\u30e5\u30bf\u30a4\u30f3\u3082EMA\u306e\u898f\u5236\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002<\/li>\n<\/ol>\n\n\n\n

        EMA\u306e\u627f\u8a8d\u3092\u53d7\u3051\u305f\u85ac\u54c1\u306f\u3001\u3053\u308c\u3089\u306e\u56fd\u3005\u3067\u81ea\u7531\u306b\u6d41\u901a\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002\u307e\u305f\u3001EMA\u306f\u3053\u308c\u3089\u306e\u56fd\u3005\u3067\u306e\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\u7d71\u4e00\u3055\u308c\u305f\u57fa\u6e96\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3068\u76e3\u8996\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306bEMA\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u5e83\u7bc4\u306a\u5730\u57df\u3067\u85ac\u54c1\u306e\u898f\u5236\u3092\u7d71\u62ec\u3057\u3066\u304a\u308a\u3001\u305d\u306e\u5f71\u97ff\u529b\u306f\u5927\u304d\u3044\u3067\u3059\u3002<\/p>\n\n\n


        \n\"\"
        \n<\/a><\/figure>\n<\/div>\n\n\n\n

        \u7d50\u8ad6<\/h2>\n\n\n\n

        \u30a4\u30f3\u30c9\u304b\u3089EU\u306b\u85ac\u3092\u8f38\u51fa\u3059\u308b\u306b\u306f\u3001\u8907\u6570\u306e\u7279\u6b8a\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u3068\u898f\u5236\u9075\u5b88\u304c\u5fc5\u8981<\/span>\u3067\u3042\u308a\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u8907\u96d1\u3067\u6642\u9593\u3092\u8981\u3057\u307e\u3059\u3002\u30a4\u30f3\u30c9\u3068EU\u306e\u4e21\u65b9\u3067\u9069\u5207\u306a\u898f\u5236\u5f53\u5c40\u306e\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3001\u305d\u308c\u306b\u9075\u5b88\u3059\u308b\u3053\u3068\u304c\u6210\u529f\u306e\u9375\u3067\u3059\u3002\u307e\u305f\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u898f\u5236\u5c02\u9580\u5bb6\u3084\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306e\u5229\u7528\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

        \u30a4\u30f3\u30c9\u306e\u898f\u5236\u8981\u4ef6 \u30e8\u30fc\u30ed\u30c3\u30d1\u9023\u5408\uff08EU\uff09\u306e\u898f\u5236\u8981\u4ef6 \u30e8\u30fc\u30ed\u30c3\u30d1\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09 \u30e8\u30fc\u30ed\u30c3\u30d1\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u9023\u5408\uff08EU\uff09\u306e\u5168\u52a0\u76df\u56fd\u306b\u5bfe\u3057\u3066\u85ac\u54c1\u306e\u8a55\u4fa1\u3068\u76e3\u8996\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002EMA\u306e\u6d3b\u52d5\u306fEU\u52a0\u76df\u56fd\u3060\u3051\u3067\u306a\u304f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u306e\u56fd\u3005\u306b\u3082\u53ca\u3073\u307e\u3059\u3002EEA\u306fEU\u52a0\u76df\u56fd\u306b\u52a0\u3048\u3066\u3001\u30ce\u30eb\u30a6\u30a7\u30fc\u3001\u30a2\u30a4\u30b9\u30e9\u30f3\u30c9\u3001\u30ea\u30d2\u30c6\u30f3\u30b7\u30e5\u30bf\u30a4\u30f3\u3092\u542b\u3093\u3067\u3044\u307e\u3059\u3002 EMA\u304c\u898f\u5236\u3059\u308b\u4e3b\u306a\u56fd\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a EMA\u306e\u627f\u8a8d\u3092\u53d7\u3051\u305f\u85ac\u54c1\u306f\u3001\u3053\u308c\u3089\u306e\u56fd\u3005\u3067\u81ea\u7531\u306b\u6d41\u901a\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3059\u3002\u307e\u305f\u3001EMA\u306f\u3053\u308c\u3089\u306e\u56fd\u3005\u3067\u306e\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\u7d71\u4e00\u3055\u308c\u305f\u57fa\u6e96\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3068\u76e3\u8996\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306bEMA\u306f\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u5e83\u7bc4\u306a\u5730\u57df\u3067\u85ac\u54c1\u306e\u898f\u5236\u3092\u7d71\u62ec\u3057\u3066\u304a\u308a\u3001\u305d\u306e\u5f71\u97ff\u529b\u306f\u5927\u304d\u3044\u3067\u3059\u3002 \u7d50\u8ad6 \u30a4\u30f3\u30c9\u304b\u3089EU\u306b\u85ac\u3092\u8f38\u51fa\u3059\u308b\u306b\u306f\u3001\u8907\u6570\u306e\u7279\u6b8a\u306a\u30e9\u30a4\u30bb\u30f3\u30b9\u3068\u898f\u5236\u9075\u5b88\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u8907\u96d1\u3067\u6642\u9593\u3092\u8981\u3057\u307e\u3059\u3002\u30a4\u30f3\u30c9\u3068EU\u306e\u4e21\u65b9\u3067\u9069\u5207\u306a\u898f\u5236\u5f53\u5c40\u306e\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3001\u305d\u308c\u306b\u9075\u5b88\u3059\u308b\u3053\u3068\u304c\u6210\u529f\u306e\u9375\u3067\u3059\u3002\u307e\u305f\u3001\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u898f\u5236\u5c02\u9580\u5bb6\u3084\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306e\u5229\u7528\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002<\/p>\n","protected":false},"author":2,"featured_media":3314,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[48],"tags":[25,40,30],"class_list":{"0":"post-478","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-others","8":"tag-beginner","9":"tag-mechanism","10":"tag-medication","11":"article"},"acf":[],"_links":{"self":[{"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/posts\/478","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/comments?post=478"}],"version-history":[{"count":11,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/posts\/478\/revisions"}],"predecessor-version":[{"id":7294,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/posts\/478\/revisions\/7294"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/media\/3314"}],"wp:attachment":[{"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/media?parent=478"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/categories?post=478"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hiro-clinic.or.jp\/ed\/wp-json\/wp\/v2\/tags?post=478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}