{"id":57622,"date":"2023-09-13T19:40:48","date_gmt":"2023-09-13T10:40:48","guid":{"rendered":"https:\/\/monolith.law\/zh-tw\/?p=57622"},"modified":"2025-11-11T13:46:43","modified_gmt":"2025-11-11T04:46:43","slug":"pharmaceutical-affairs-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceutical-affairs-law","title":{"rendered":"\u300c\u85e5\u54c1\u300d\u3001\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u548c\u300c\u5316\u599d\u54c1\u300d\u7684\u5340\u5225\u662f\u4ec0\u9ebc\uff1f"},"content":{"rendered":"\n<p>\u85e5\u6a5f\u6cd5\uff0c\u65e5\u672c\u7684\u6b63\u5f0f\u540d\u7a31\u70ba\u300c\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u78ba\u4fdd\u7b49\u76f8\u95dc\u6cd5\u5f8b\u300d\uff0c\u5c07\u6240\u8b02\u7684\u5316\u599d\u54c1\u3001\u85e5\u54c1\u7b49\u5404\u7a2e\u5546\u54c1\uff0c\u5340\u5206\u70ba\u300c\u85e5\u54c1\u300d\u3001\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u3001\u300c\u5316\u599d\u54c1\u300d\u3002\u9019\u4e9b\u5340\u5206\u5728\u5ee3\u544a\u898f\u7bc4\u65b9\u9762\u6975\u70ba\u91cd\u8981\u3002<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_53 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceutical-affairs-law\/#%E3%80%8C%E8%97%A5%E5%93%81%E3%80%8D%E3%80%81%E3%80%8C%E9%86%AB%E8%97%A5%E9%83%A8%E5%A4%96%E5%93%81%E3%80%8D%E8%88%87%E3%80%8C%E5%8C%96%E5%A6%9D%E5%93%81%E3%80%8D%E7%9A%84%E5%8D%80%E5%88%A5\" title=\" \u300c\u85e5\u54c1\u300d\u3001\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u8207\u300c\u5316\u599d\u54c1\u300d\u7684\u5340\u5225 \"> \u300c\u85e5\u54c1\u300d\u3001\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u8207\u300c\u5316\u599d\u54c1\u300d\u7684\u5340\u5225 <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceutical-affairs-law\/#%E3%80%8C%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E4%B8%8A%E7%9A%84%E3%80%8C%E9%86%AB%E8%97%A5%E5%93%81%E3%80%8D%E5%AE%9A%E7%BE%A9\" title=\"\u300c\u85e5\u6a5f\u6cd5\u300d\u4e0a\u7684\u300c\u91ab\u85e5\u54c1\u300d\u5b9a\u7fa9 \">\u300c\u85e5\u6a5f\u6cd5\u300d\u4e0a\u7684\u300c\u91ab\u85e5\u54c1\u300d\u5b9a\u7fa9 <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceutical-affairs-law\/#%E5%9C%A8%E3%80%8C%E6%97%A5%E6%9C%AC%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E4%B8%AD%E3%80%8C%E9%86%AB%E8%97%A5%E9%83%A8%E5%A4%96%E5%93%81%E3%80%8D%E7%9A%84%E5%AE%9A%E7%BE%A9\" title=\"\u5728\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u4e2d\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u7684\u5b9a\u7fa9\">\u5728\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u4e2d\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u7684\u5b9a\u7fa9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceutical-affairs-law\/#%E3%80%8C%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E5%B0%8D%E3%80%8C%E5%8C%96%E5%A6%9D%E5%93%81%E3%80%8D%E7%9A%84%E5%AE%9A%E7%BE%A9\" title=\"\u300c\u85e5\u6a5f\u6cd5\u300d\u5c0d\u300c\u5316\u599d\u54c1\u300d\u7684\u5b9a\u7fa9\">\u300c\u85e5\u6a5f\u6cd5\u300d\u5c0d\u300c\u5316\u599d\u54c1\u300d\u7684\u5b9a\u7fa9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceutical-affairs-law\/#%E8%88%87%E5%BB%A3%E5%91%8A%E8%A6%8F%E7%AF%84%E7%9A%84%E9%97%9C%E4%BF%82\" title=\"\u8207\u5ee3\u544a\u898f\u7bc4\u7684\u95dc\u4fc2\">\u8207\u5ee3\u544a\u898f\u7bc4\u7684\u95dc\u4fc2<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%80%8C%E8%97%A5%E5%93%81%E3%80%8D%E3%80%81%E3%80%8C%E9%86%AB%E8%97%A5%E9%83%A8%E5%A4%96%E5%93%81%E3%80%8D%E8%88%87%E3%80%8C%E5%8C%96%E5%A6%9D%E5%93%81%E3%80%8D%E7%9A%84%E5%8D%80%E5%88%A5\"><\/span> \u300c\u85e5\u54c1\u300d\u3001\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u8207\u300c\u5316\u599d\u54c1\u300d\u7684\u5340\u5225 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>\u300c\u85e5\u54c1\u300d\u662f\u542b\u6709\u5177\u6709\u91ab\u85e5\u6548\u679c\u7684\u6210\u5206\uff0c\u5c0d\u6cbb\u7642\u548c\u9810\u9632\u6709\u6548\u7684\u85e5\u7269\u3002<\/li>\n\n\n\n<li>\u300c\u85e5\u7528\u5316\u599d\u54c1\u300d\u4e0d\u5c6c\u65bc\u300c\u85e5\u54c1\u300d\uff0c\u4f46\u8207\u300c\u85e5\u54c1\u300d\u76f8\u4f3c\uff0c\u4f4d\u65bc\u300c\u5316\u599d\u54c1\u300d\u548c\u300c\u85e5\u54c1\u300d\u4e4b\u9593\u3002<\/li>\n\n\n\n<li>\u300c\u5316\u599d\u54c1\u300d\u662f\u4ee5\u7f8e\u5bb9\u70ba\u76ee\u7684\u958b\u767c\u7684\u5546\u54c1\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u5728\u4e0a\u8ff0\u4e09\u7a2e\u5340\u5225\u548c\u5ee3\u544a\u4e4b\u9593\u7684\u91cd\u8981\u95dc\u4fc2\u662f\uff0c\u300c\u85e5\u54c1\u300d\u548c\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u53ef\u4ee5\u5217\u51fa\u6709\u6548\u6210\u5206\uff0c\u800c\u300c\u5316\u599d\u54c1\u300d\u4e0d\u80fd\u5ba3\u7a31\u6709\u6709\u6548\u6210\u5206\u3002<\/p>\n\n\n\n<p>\u53e6\u5916\uff0c\u6240\u8b02\u7684\u300c\u5316\u599d\u54c1\u300d\u6839\u64da\u85e5\u6a5f\u6cd5\uff08Japanese Pharmaceutical Affairs Law\uff09\u88ab\u5206\u70ba\u300c\u5316\u599d\u54c1\u300d\u548c\u300c\u85e5\u7528\u5316\u599d\u54c1\u300d\u3002\u300c\u5316\u599d\u54c1\u300d\u671f\u5f85\u7684\u6548\u679c\u662f\u4fdd\u6fd5\u548c\u6e05\u6f54\u7b49\uff0c\u671f\u5f85\u6574\u500b\u7522\u54c1\u7684\u6548\u679c\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u300c\u85e5\u7528\u5316\u599d\u54c1\u300d\u9664\u4e86\u5316\u599d\u54c1\u7684\u671f\u5f85\u6548\u679c\u5916\uff0c\u9084\u542b\u6709\u9632\u6b62\u76ae\u819a\u708e\u75c7\u3001\u7c89\u523a\u3001\u7f8e\u767d\u3001\u9664\u81ed\u7b49\u6548\u679c\u7684\u300c\u6709\u6548\u6210\u5206\u300d\uff0c\u4f4d\u65bc\u5316\u599d\u54c1\u548c\u85e5\u54c1\u4e4b\u9593\uff0c\u88ab\u5206\u985e\u70ba\u300c\u85e5\u7528\u5316\u599d\u54c1\u300d\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%80%8C%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E4%B8%8A%E7%9A%84%E3%80%8C%E9%86%AB%E8%97%A5%E5%93%81%E3%80%8D%E5%AE%9A%E7%BE%A9\"><\/span>\u300c\u85e5\u6a5f\u6cd5\u300d\u4e0a\u7684\u300c\u91ab\u85e5\u54c1\u300d\u5b9a\u7fa9 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" loading=\"lazy\" width=\"735\" height=\"490\" src=\"https:\/\/monolith.law\/zh-tw\/wp-content\/uploads\/sites\/8\/2025\/11\/pharmaceutical-affairs-law-2.jpg\" alt=\"\" class=\"wp-image-74226\" style=\"aspect-ratio:1.5;width:840px;height:auto\" srcset=\"https:\/\/monolith.law\/zh-tw\/wp-content\/uploads\/sites\/8\/2025\/11\/pharmaceutical-affairs-law-2.jpg 735w, https:\/\/monolith.law\/zh-tw\/wp-content\/uploads\/sites\/8\/2025\/11\/pharmaceutical-affairs-law-2-300x200.jpg 300w, https:\/\/monolith.law\/zh-tw\/wp-content\/uploads\/sites\/8\/2025\/11\/pharmaceutical-affairs-law-2-250x167.jpg 250w\" sizes=\"(max-width: 735px) 100vw, 735px\" \/><figcaption class=\"wp-element-caption\">\u300c\u91ab\u85e5\u54c1\u300d\u548c\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u5404\u81ea\u662f\u5982\u4f55\u5b9a\u7fa9\u7684\u5462\uff1f<\/figcaption><\/figure>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u300c\u5728\u672c\u6cd5\u4e2d\uff0c\u300c\u91ab\u85e5\u54c1\u300d\u6307\u7684\u662f\u4ee5\u4e0b\u6240\u5217\u7684\u7269\u54c1\u3002<br> \u4e00\u3001\u6536\u9304\u5728\u65e5\u672c\u85e5\u5178\u4e2d\u7684\u7269\u54c1<br> \u4e8c\u3001\u88ab\u8996\u70ba\u7528\u65bc\u4eba\u985e\u6216\u52d5\u7269\u7684\u75be\u75c5\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632\u7684\u7269\u54c1\uff0c\u4e26\u4e14\u4e0d\u662f\u6a5f\u68b0\u5668\u5177\u7b49\uff08\u6a5f\u68b0\u5668\u5177\u3001\u7259\u79d1\u6750\u6599\u3001\u91ab\u7642\u7528\u54c1\u3001\u885b\u751f\u7528\u54c1\u4ee5\u53ca\u7a0b\u5e8f\uff08\u5c0d\u96fb\u5b50\u8a08\u7b97\u6a5f\u7684\u6307\u4ee4\uff0c\u53ef\u4ee5\u5f97\u5230\u67d0\u7a2e\u7d50\u679c\u7684\u7d44\u5408\u7269\u3002\u4ee5\u4e0b\u540c\u6a23\u3002\uff09\u4ee5\u53ca\u8a18\u9304\u9019\u4e9b\u7684\u8a18\u9304\u5a92\u9ad4\u3002\u4ee5\u4e0b\u540c\u6a23\u3002\uff09\uff08\u4e0d\u5305\u62ec\u91ab\u85e5\u90e8\u5916\u54c1\u548c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u3002\uff09<br> \u4e09\u3001\u88ab\u8996\u70ba\u5f71\u97ff\u4eba\u985e\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u7684\u7269\u54c1\uff0c\u4e26\u4e14\u4e0d\u662f\u6a5f\u68b0\u5668\u5177\u7b49\uff08\u4e0d\u5305\u62ec\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u548c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u3002\uff09\u300d<br><\/p>\n<cite>  \u85e5\u6a5f\u6cd5\u7b2c2\u689d\u7b2c1\u9805 <\/cite><\/blockquote>\n\n\n\n<p>\u6839\u64da\u4e0a\u8ff0\u5b9a\u7fa9\u898f\u5b9a\uff0c\u5728\u85e5\u6a5f\u6cd5\u4e0a\uff0c\u300c\u91ab\u85e5\u54c1\u300d\u662f\u6307\u300c\u7528\u65bc\u4eba\u985e\u6216\u52d5\u7269\u7684\u75be\u75c5\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632\u300d\u4ee5\u53ca\u300c\u5f71\u97ff\u4eba\u985e\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u300d\u7684\u7269\u54c1\u3002\u9019\u4e00\u9ede\u975e\u5e38\u91cd\u8981\uff0c\u300c\u91ab\u85e5\u54c1\u300d\u7684\u5b9a\u7fa9\u5c31\u662f\u300c\u88ab\u7528\u65bc\u9019\u4e9b\u76ee\u7684\u7684\u7269\u54c1\u5c31\u662f\u91ab\u85e5\u54c1\u300d\u3002<\/p>\n\n\n\n<p>\u53e6\u5916\uff0c\u88dc\u5145\u5291\u662f\u4e00\u7a2e\u8f14\u52a9\u98df\u54c1\uff0c\u7528\u65bc\u88dc\u5145\u98f2\u98df\u7121\u6cd5\u5145\u5206\u651d\u53d6\u7684\u71df\u990a\u7d20\uff0c\u4e26\u4e0d\u7b26\u5408\u4e0a\u8ff0\u5b9a\u7fa9\uff0c\u56e0\u6b64\u88ab\u5206\u985e\u70ba\u300c\u98df\u54c1\u300d\u800c\u975e\u300c\u91ab\u85e5\u54c1\u300d\u3002\u63db\u53e5\u8a71\u8aaa\uff0c\u670d\u7528\u88dc\u5145\u5291\u7684\u884c\u70ba\u4e26\u975e\u70ba\u4e86\u9810\u9632\u6216\u6539\u5584\u75be\u75c5\uff0c\u800c\u662f\u70ba\u4e86\u88dc\u5145\u4e0d\u8db3\u7684\u71df\u990a\u7d20\uff0c\u56e0\u6b64\u88dc\u5145\u5291\u4e26\u4e0d\u5c6c\u65bc\u300c\u91ab\u85e5\u54c1\u300d\uff0c\u56e0\u6b64\u4e0d\u53d7\u300c\u91ab\u85e5\u54c1\u300d\u7684\u6cd5\u5f8b\u898f\u5b9a\u7684\u7d04\u675f\uff0c\u9019\u5c31\u662f\u5176\u5b9a\u4f4d\u7684\u4f9d\u64da\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%9C%A8%E3%80%8C%E6%97%A5%E6%9C%AC%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E4%B8%AD%E3%80%8C%E9%86%AB%E8%97%A5%E9%83%A8%E5%A4%96%E5%93%81%E3%80%8D%E7%9A%84%E5%AE%9A%E7%BE%A9\"><\/span>\u5728\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u4e2d\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u7684\u5b9a\u7fa9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u300c\u5728\u672c\u6cd5\u4e2d\uff0c\u300c\u91ab\u85e5\u90e8\u5916\u54c1\u300d\u6307\u7684\u662f\u4ee5\u4e0b\u5217\u51fa\u7684\u7269\u54c1\uff0c\u5176\u5c0d\u4eba\u9ad4\u7684\u4f5c\u7528\u8f03\u70ba\u7de9\u548c\u3002<br> 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