{"id":67234,"date":"2024-04-10T16:01:56","date_gmt":"2024-04-10T07:01:56","guid":{"rendered":"https:\/\/monolith.law\/zh-tw\/?p=67234"},"modified":"2024-04-19T16:34:38","modified_gmt":"2024-04-19T07:34:38","slug":"pharmaceuticals-law","status":"publish","type":"post","link":"https:\/\/monolith.law\/zh-tw\/general-corporate\/pharmaceuticals-law","title":{"rendered":"\u300c\u85e5\u6a5f\u6cd5(\u820a\u85e5\u4e8b\u6cd5)\u662f\u4ec0\u9ebc?\u76ee\u7684\u3001\u898f\u7bc4\u5c0d\u8c61\u548c\u5ee3\u544a\u898f\u7bc4\u7684\u89e3\u91cb\u300d"},"content":{"rendered":"\n<p>\u7576\u672c\u6240\u63d0\u5230\u300c\u85e5\u6a5f\u6cd5\u300d\uff08Japanese Pharmaceutical Affairs 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class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%97%A5%E6%A9%9F%E6%B3%95%E7%9A%84%E7%9B%AE%E7%9A%84\"><\/span>\u85e5\u6a5f\u6cd5\u7684\u76ee\u7684<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u85e5\u6a5f\u6cd5\u7684\u76ee\u7684\u5728\u7b2c\u4e00\u689d\u4e2d\u6709\u6240\u898f\u5b9a\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u672c\u6cd5\u7684\u76ee\u7684\u662f\u5c0d\u85e5\u54c1\u3001\u85e5\u54c1\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u53ca\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff08\u4ee5\u4e0b\u7c21\u7a31\u300c\u85e5\u54c1\u7b49\u300d\uff09\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u9032\u884c\u5fc5\u8981\u7684\u898f\u7bc4\uff0c\u4e26\u9632\u6b62\u9019\u4e9b\u7522\u54c1\u7684\u4f7f\u7528\u5c0e\u81f4\u5065\u5eb7\u885b\u751f\u4e0a\u7684\u5371\u5bb3\u7684\u767c\u751f\u548c\u64f4\u5927\uff0c\u540c\u6642\u5c0d\u300c\u6307\u5b9a\u85e5\u7269\u300d\uff08\u5371\u96aa\u85e5\u54c1\uff09\u9032\u884c\u898f\u7bc4\uff0c\u4e26\u5c0d\u91ab\u7642\u4e0a\u7279\u5225\u9700\u8981\u7684\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u53ca\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u7814\u7a76\u958b\u767c\u9032\u884c\u5fc5\u8981\u7684\u63a8\u52d5\uff0c\u4ee5\u6b64\u63d0\u9ad8\u5065\u5eb7\u885b\u751f\u6c34\u5e73\u3002<\/p>\n<cite>\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 \u7b2c\u4e00\u689d<\/cite><\/blockquote>\n\n\n\n<p>\u6574\u7406\u7b2c\u4e00\u689d\u7684\u898f\u5b9a\uff0c\u53ef\u4ee5\u5f97\u51fa\u4ee5\u4e0b\u5e7e\u9ede\uff1a<\/p>\n\n\n\n<ol>\n<li>\u5c0d\u85e5\u54c1\u3001\u85e5\u54c1\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u3001\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u4e94\u7a2e\uff08\u85e5\u54c1\u7b49\uff09\u9032\u884c\u5fc5\u8981\u7684\u898f\u7bc4\uff0c\u4ee5\u78ba\u4fdd\u5176\u5b89\u5168\u6027<\/li>\n\n\n\n<li>\u5c0d\u300c\u6307\u5b9a\u85e5\u7269\u300d\uff08\u5371\u96aa\u85e5\u54c1\uff09\u9032\u884c\u898f\u7bc4<\/li>\n\n\n\n<li>\u63a8\u52d5\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u3001\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u958b\u767c\u7814\u7a76<\/li>\n<\/ol>\n\n\n\n<p>\u85e5\u6a5f\u6cd5\u5c31\u662f\u6839\u64da\u9019\u4e09\u500b\u76ee\u7684\u4f86\u5236\u5b9a\u76f8\u95dc\u898f\u7bc4\u7684\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%97%A5%E6%A9%9F%E6%B3%95%E7%9A%84%E4%B8%BB%E8%A6%81%E7%9B%A3%E7%AE%A1%E5%B0%8D%E8%B1%A1%E5%92%8C%E5%AE%9A%E7%BE%A9\"><\/span>\u85e5\u6a5f\u6cd5\u7684\u4e3b\u8981\u76e3\u7ba1\u5c0d\u8c61\u548c\u5b9a\u7fa9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith-law.jp\/wp-content\/uploads\/2022\/08\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-2.png\" alt=\"\u85e5\u6a5f\u6cd5\u7684\u4e3b\u8981\u76e3\u7ba1\u5c0d\u8c61\u548c\u5b9a\u7fa9\" class=\"wp-image-49927\" \/><\/figure>\n\n\n\n<p>\u70ba\u4e86\u907f\u514d\u9055\u53cd\u85e5\u6a5f\u6cd5\uff0c\u672c\u6240\u5fc5\u9808\u6b63\u78ba\u7406\u89e3\u85e5\u6a5f\u6cd5\u7684\u76e3\u7ba1\u5c0d\u8c61\u3002<\/p>\n\n\n\n<p>\u85e5\u6a5f\u6cd5\u7684\u4e3b\u8981\u76e3\u7ba1\u5c0d\u8c61\u5982\u7b2c1\u689d\u6240\u8ff0\uff0c\u5305\u62ec\u85e5\u54c1\u3001\u85e5\u7528\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u4ee5\u53ca\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u4e94\u7a2e\u3002\u8b93\u672c\u6240\u4f86\u78ba\u8a8d\u4e00\u4e0b\u5404\u81ea\u7684\u5b9a\u7fa9\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%97%A5%E5%93%81\"><\/span>\u85e5\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u7576\u672c\u6240\u807d\u5230\u300c\u85e5\u54c1\u300d\u9019\u500b\u8a5e\uff0c\u5f88\u591a\u4eba\u53ef\u80fd\u6703\u60f3\u5230\u5728\u85e5\u623f\u7372\u5f97\u7684\u8655\u65b9\u85e5\u6216\u662f\u89e3\u71b1\u85e5\u7b49\u3002\u7136\u800c\uff0c\u5be6\u969b\u4e0a\uff0c\u8a31\u591a\u5176\u4ed6\u7684\u7269\u54c1\u4e5f\u5c6c\u65bc\u300c\u85e5\u54c1\u300d\u7684\u7bc4\u7587\u3002<\/p>\n\n\n\n<p>\u5728\u65e5\u672c\u7684\u300c\u85e5\u4e8b\u6cd5\u300d\uff08Japanese Pharmaceutical Affairs Law\uff09\u4e2d\uff0c\u5c0d\u65bc\u85e5\u54c1\u7684\u5b9a\u7fa9\u5df2\u5728\u7b2c2\u689d\u7b2c1\u9805\u4e2d\u660e\u78ba\u898f\u5b9a\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u5728\u6b64\u6cd5\u5f8b\u4e2d\uff0c\u300c\u85e5\u54c1\u300d\u6307\u7684\u662f\u4ee5\u4e0b\u6240\u5217\u7684\u7269\u54c1\uff1a<\/p>\n\n\n\n<p>\u4e00\u3001\u6536\u9304\u5728\u65e5\u672c\u85e5\u5178\u4e2d\u7684\u7269\u54c1<\/p>\n\n\n\n<p>\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\u6307\u5c0d\u96fb\u5b50\u8a08\u7b97\u6a5f\u7684\u6307\u4ee4\uff0c\u53ef\u4ee5\u5f97\u5230\u67d0\u7a2e\u7d50\u679c\u7684\u7d44\u5408\u3002\u4ee5\u4e0b\u540c\u3002\uff09\u4ee5\u53ca\u8a18\u9304\u9019\u4e9b\u7684\u8a18\u9304\u5a92\u9ad4\u3002\u4ee5\u4e0b\u540c\u3002\uff09\uff08\u4e0d\u5305\u62ec\u85e5\u54c1\u90e8\u5916\u54c1\u548c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u3002\uff09<\/p>\n\n\n\n<p>\u4e09\u3001\u88ab\u8996\u70ba\u5c0d\u4eba\u985e\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u7522\u751f\u5f71\u97ff\u7684\u7269\u54c1\uff0c\u4e26\u4e14\u4e0d\u662f\u6a5f\u68b0\u5668\u5177\u7b49\uff08\u4e0d\u5305\u62ec\u85e5\u54c1\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u548c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u3002\uff09<\/p>\n<cite>\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 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class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%97%A5%E5%93%81%E5%8F%8A%E5%85%B6%E4%BB%A5%E5%A4%96%E7%9A%84%E7%89%A9%E5%93%81\"><\/span>\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u6211\u8a8d\u70ba\u5c0d\u65bc\u300c\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u300d\uff08\u65e5\u672c\u7684\u300c\u533b\u85ac\u90e8\u5916\u54c1\u300d\uff09\u7684\u6b63\u78ba\u7406\u89e3\u7684\u4eba\u4e26\u4e0d\u591a\u3002\u5927\u81f4\u4f86\u8aaa\uff0c\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u6307\u7684\u662f\u5c0d\u4eba\u9ad4\u6709\u5f71\u97ff\uff0c\u4f46\u76f8\u6bd4\u85e5\u54c1\uff0c\u5176\u5f71\u97ff\u8f03\u70ba\u6eab\u548c\uff0c\u56e0\u6b64\u53d7\u5230\u7684\u898f\u7bc4\u4e5f\u8f03\u70ba\u5bec\u9b06\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u7684\u300c\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u78ba\u4fdd\u7b49\u6cd5\u300d\uff08\u85ac\u6a5f\u6cd5\uff09\u5728\u7b2c2\u689d\u7b2c2\u9805\u4e2d\u5c0d\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u9032\u884c\u4e86\u5b9a\u7fa9\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u5728\u9019\u90e8\u6cd5\u5f8b\u4e2d\uff0c\u300c\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u300d\u6307\u7684\u662f\u5c0d\u4eba\u9ad4\u6709\u6eab\u548c\u4f5c\u7528\u7684\u4ee5\u4e0b\u7269\u54c1\uff1a<\/p>\n\n\n\n<p>\u4e00\u3001\u7528\u65bc\u4ee5\u4e0b\u76ee\u7684\u7684\u7269\u54c1\uff08\u9664\u4e86\u9019\u4e9b\u4f7f\u7528\u76ee\u7684\u5916\uff0c\u9084\u6709\u7528\u65bc\u524d\u9805\u7b2c\u4e8c\u865f\u6216\u7b2c\u4e09\u865f\u898f\u5b9a\u7684\u76ee\u7684\u7684\u7269\u54c1\uff09\uff0c\u4e26\u4e14\u4e0d\u662f\u6a5f\u68b0\u5668\u5177\u7b49<\/p>\n\n\n\n<p>\u30a4\u3001\u9632\u6b62\u5641\u5fc3\u548c\u5176\u4ed6\u4e0d\u9069\u611f\u6216\u53e3\u81ed\u6216\u9ad4\u81ed<\/p>\n\n\n\n<p>\u30ed\u3001\u9632\u6b62\u71b1\u75b9\u3001\u76ae\u75b9\u7b49<\/p>\n\n\n\n<p>\u30cf\u3001\u9632\u6b62\u812b\u9aee\uff0c\u4fc3\u9032\u6bdb\u9aee\u751f\u9577\u6216\u9664\u6bdb<\/p>\n\n\n\n<p>\u4e8c\u3001\u7528\u65bc\u4eba\u6216\u52d5\u7269\u7684\u5065\u5eb7\uff0c\u9632\u6b62\u8001\u9f20\u3001\u84bc\u8805\u3001\u868a\u5b50\u3001\u8df3\u86a4\u7b49\u985e\u4f3c\u751f\u7269\u7684\u7269\u54c1\uff08\u9664\u4e86\u9019\u4e9b\u4f7f\u7528\u76ee\u7684\u5916\uff0c\u9084\u6709\u7528\u65bc\u524d\u9805\u7b2c\u4e8c\u865f\u6216\u7b2c\u4e09\u865f\u898f\u5b9a\u7684\u76ee\u7684\u7684\u7269\u54c1\uff09\uff0c\u4e26\u4e14\u4e0d\u662f\u6a5f\u68b0\u5668\u5177\u7b49<\/p>\n\n\n\n<p>\u4e09\u3001\u7528\u65bc\u524d\u9805\u7b2c\u4e8c\u865f\u6216\u7b2c\u4e09\u865f\u898f\u5b9a\u7684\u76ee\u7684\u7684\u7269\u54c1\uff08\u4e0d\u5305\u62ec\u524d\u4e8c\u865f\u7684\u7269\u54c1\uff09\uff0c\u7531\u539a\u751f\u52de\u52d5\u5927\u81e3\u6307\u5b9a\u7684\u7269\u54c1<\/p>\n<cite>\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u78ba\u4fdd\u7b49\u6cd5 \u7b2c\u4e8c\u689d\u7b2c\u4e8c\u9805<\/cite><\/blockquote>\n\n\n\n<p>\u5f9e\u4e0a\u8ff0\u898f\u5b9a\u53ef\u4ee5\u770b\u51fa\uff0c\u5c0d\u4eba\u9ad4\u6709\u6eab\u548c\u4f5c\u7528\u7684\u7269\u54c1\uff0c\u5305\u62ec\u2460\u7528\u65bc\u9632\u6b62\u5641\u5fc3\u7b49\u7684\u7269\u54c1\uff0c\u2461\u7528\u65bc\u9632\u6b62\u8001\u9f20\u7b49\u7684\u7269\u54c1\uff0c\u4ee5\u53ca\u2462\u7531\u539a\u751f\u52de\u52d5\u5927\u81e3\u6307\u5b9a\u7684\u7269\u54c1\uff0c\u90fd\u5c6c\u65bc\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u3002<\/p>\n\n\n\n<p>\u4f8b\u5982\uff0c\u5c6c\u65bc\u2460\u7684\u7269\u54c1\u6709\u53e3\u81ed\u5674\u9727\u3001\u6f31\u53e3\u6db2\u3001\u9632\u6b62\u5243\u9b1a\u75bc\u75db\u7684\u4e73\u971c\u3001\u990a\u9aee\u5291\u3001\u9664\u6bdb\u5291\u7b49\u3002<\/p>\n\n\n\n<p>\u5c6c\u65bc\u2461\u7684\u7269\u54c1\u6709\u868a\u9999\u3001\u6355\u9f20\u5668\u3001\u6bba\u87f2\u5291\u7b49\u3002<\/p>\n\n\n\n<p>\u2462\u662f\u4e00\u9805\u898f\u5b9a\uff0c\u5373\u5373\u4f7f\u672c\u4f86\u5c6c\u65bc\u300c\u85e5\u54c1\u300d\u7684\u7269\u54c1\uff0c\u5982\u679c\u88ab\u539a\u751f\u52de\u52d5\u5927\u81e3\u6307\u5b9a\uff0c\u4e5f\u6703\u88ab\u8996\u70ba\u300c\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u300d\u3002\u9019\u662f\u56e0\u70ba\u9019\u4e9b\u7269\u54c1\u7684\u4f5c\u7528\u6eab\u548c\uff0c\u5373\u4f7f\u5728\u4e00\u822c\u96f6\u552e\u5e97\u92b7\u552e\uff0c\u4e5f\u4e0d\u6703\u5c0d\u570b\u6c11\u7684\u5065\u5eb7\u7522\u751f\u5f71\u97ff\uff0c\u56e0\u6b64\u5236\u5b9a\u4e86\u9019\u6a23\u7684\u898f\u5b9a\uff0c\u4ee5\u4fc3\u9032\u5176\u6d41\u901a\u3002<\/p>\n\n\n\n<p>\u4f8b\u5982\uff0c\u5c6c\u65bc\u2462\u7684\u7269\u54c1\u6709\u96b1\u5f62\u773c\u93e1\u6d88\u6bd2\u6db2\u3001\u6bba\u83cc\u6d88\u6bd2\u6db2\u3001\u6574\u8178\u5291\u3001\u67d3\u9aee\u5291\u7b49\u3002<\/p>\n\n\n\n<p>\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\uff0c\u8207\u85e5\u54c1\u4e00\u6a23\uff0c\u5c0d\u4eba\u9ad4\u6709\u4e00\u5b9a\u7684\u4f5c\u7528\uff0c\u4f46\u8207\u85e5\u54c1\u76f8\u6bd4\uff0c\u5176\u4f5c\u7528\u662f\u300c\u6eab\u548c\u7684\u300d\u3002\u4f8b\u5982\uff0c\u672c\u6240\u63d0\u5230\u7684\u2461\u7684\u4f8b\u5b50\u4e2d\u7684\u6bba\u87f2\u5291\uff0c\u5982\u679c\u5b83\u542b\u6709\u5c0d\u4eba\u9ad4\u6709\u76f8\u7576\u5f37\u70c8\u4f5c\u7528\u7684\u6210\u5206\uff0c\u90a3\u9ebc\u5b83\u5c31\u4e0d\u5c6c\u65bc\u300c\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u300d\uff0c\u800c\u662f\u300c\u85e5\u54c1\u300d\u3002<\/p>\n\n\n\n<p>\u5c0d\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u7684\u4e3b\u8981\u898f\u5b9a\u7c21\u55ae\u4f86\u8aaa\u5c31\u662f\u88fd\u9020\u8a31\u53ef\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u92b7\u552e\u4e0d\u9700\u8981\u7372\u5f97\u8a31\u53ef\u3002\u4e5f\u5c31\u662f\u8aaa\uff0c\u85e5\u54c1\u53ca\u5176\u4ee5\u5916\u7684\u7269\u54c1\u53ef\u4ee5\u5728\u4e00\u822c\u7684\u96f6\u552e\u5e97\u81ea\u7531\u92b7\u552e\u3002\u7136\u800c\uff0c\u5982\u5f8c\u6587\u6240\u8ff0\uff0c\u5ee3\u544a\u662f\u53d7\u5230\u898f\u5b9a\u7684\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%96%E5%A6%9D%E5%93%81\"><\/span>\u5316\u599d\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u63d0\u5230\u5316\u599d\u54c1\uff0c\u8a31\u591a\u4eba\u53ef\u80fd\u6703\u60f3\u5230\u5973\u6027\u70ba\u4e86\u6253\u626e\u800c\u4f7f\u7528\u7684\u7522\u54c1\u3002\u7136\u800c\uff0c\u5728\u65e5\u672c\u300a\u85e5\u4e8b\u6cd5\u300b\uff08Pharmaceutical Affairs Law\uff09\u4e2d\u6240\u5b9a\u7fa9\u7684\u300c\u5316\u599d\u54c1\u300d\uff0c\u5176\u7bc4\u7587\u5be6\u969b\u4e0a\u66f4\u70ba\u5ee3\u6cdb\u3002<\/p>\n\n\n\n<p>\u300a\u85e5\u4e8b\u6cd5\u300b\u5728\u7b2c2\u689d\u7b2c3\u9805\u4e2d\u5c0d\u5316\u599d\u54c1\u9032\u884c\u4e86\u5b9a\u7fa9\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u5728\u672c\u6cd5\u4e2d\uff0c\u300c\u5316\u599d\u54c1\u300d\u6307\u7684\u662f\u70ba\u4e86\u6e05\u6f54\u4eba\u9ad4\u3001\u7f8e\u5316\u3001\u589e\u52a0\u9b45\u529b\u3001\u6539\u8b8a\u5bb9\u8c8c\uff0c\u6216\u4fdd\u6301\u76ae\u819a\u6216\u982d\u9aee\u5065\u5eb7\uff0c\u800c\u5857\u62b9\u3001\u5674\u7051\u6216\u4ee5\u5176\u4ed6\u985e\u4f3c\u65b9\u5f0f\u4f7f\u7528\u5728\u8eab\u9ad4\u4e0a\u7684\u7269\u54c1\uff0c\u5176\u5c0d\u4eba\u9ad4\u7684\u4f5c\u7528\u662f\u6eab\u548c\u7684\u3002\u7136\u800c\uff0c\u9664\u4e86\u4e0a\u8ff0\u4f7f\u7528\u76ee\u7684\u5916\uff0c\u9084\u5305\u62ec\u540c\u6642\u88ab\u898f\u5b9a\u70ba\u7b2c\u4e00\u9805\u7b2c\u4e8c\u865f\u6216\u7b2c\u4e09\u865f\u7528\u9014\u7684\u7269\u54c1\uff0c\u4ee5\u53ca\u4e0d\u5305\u62ec\u85e5\u54c1\u548c\u91ab\u7642\u5668\u68b0\u3002<\/p>\n<cite>\u65e5\u672c\u300a\u85e5\u4e8b\u6cd5\u300b\u7b2c\u4e8c\u689d\u7b2c\u4e09\u9805<\/cite><\/blockquote>\n\n\n\n<p>\u5f9e\u4e0a\u8ff0\u898f\u5b9a\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u9664\u4e86\u4e00\u822c\u5973\u6027\u5316\u599d\u54c1\u7684\u300c\u7f8e\u5316\u3001\u589e\u52a0\u9b45\u529b\u3001\u6539\u8b8a\u5bb9\u8c8c\u300d\u4e4b\u5916\uff0c\u50cf\u662f\u6d17\u9aee\u7cbe\u6216\u7259\u818f\u9019\u7a2e\u300c\u6e05\u6f54\u4eba\u9ad4\u300d\u7684\u7522\u54c1\uff0c\u4ee5\u53ca\u8b77\u819a\u54c1\u6216\u8eab\u9ad4\u4e73\u6db2\u9019\u7a2e\u300c\u4fdd\u6301\u76ae\u819a\u6216\u982d\u9aee\u5065\u5eb7\u300d\u7684\u7522\u54c1\uff0c\u4e5f\u90fd\u88ab\u8996\u70ba\u5316\u599d\u54c1\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u96d6\u7136\u5316\u599d\u54c1\u5c0d\u4eba\u9ad4\u6709\u4e00\u5b9a\u7684\u4f5c\u7528\uff0c\u4f46\u4e26\u4e0d\u5305\u62ec\u5177\u6709\u85e5\u6548\u6216\u6bba\u83cc\u4f5c\u7528\u7684\u7522\u54c1\u3002\u4f8b\u5982\uff0c\u50c5\u7528\u65bc\u6e05\u6f54\u7684\u7259\u818f\u88ab\u8996\u70ba\u5316\u599d\u54c1\uff0c\u4f46\u5ba3\u7a31\u53ef\u4ee5\u9810\u9632\u7259\u5468\u75c5\u7684\u7259\u818f\uff0c\u7531\u65bc\u671f\u5f85\u5176\u85e5\u6548\uff0c\u53ef\u80fd\u88ab\u8996\u70ba\u85e5\u54c1\u6216\u91ab\u7642\u5668\u68b0\u3002<\/p>\n\n\n\n<p>\u518d\u8005\uff0c\u5316\u599d\u54c1\u50c5\u9650\u65bc\u5857\u62b9\u7b49\u5728\u8eab\u9ad4\u4e0a\u7684\u7522\u54c1\uff0c\u56e0\u6b64\uff0c\u98f2\u7528\u6216\u6ce8\u5165\u8eab\u9ad4\u7684\u7522\u54c1\u4e26\u4e0d\u88ab\u8996\u70ba\u5316\u599d\u54c1\u3002<\/p>\n\n\n\n<p>\u5c0d\u5316\u599d\u54c1\u7684\u4e3b\u8981\u898f\u5b9a\u5167\u5bb9\u662f\u88fd\u9020\u8a31\u53ef\u548c\u7533\u5831\uff0c\u76f8\u5c0d\u65bc\u85e5\u54c1\u548c\u91ab\u7642\u5668\u68b0\u7684\u898f\u5b9a\u8f03\u70ba\u5bec\u9b06\u3002\u5316\u599d\u54c1\u53ef\u4ee5\u5728\u4e00\u822c\u96f6\u552e\u5e97\u81ea\u7531\u92b7\u552e\u3002\u7136\u800c\uff0c\u5982\u4e0b\u6587\u6240\u8ff0\uff0c\u5ee3\u544a\u898f\u5b9a\u4ecd\u7136\u9069\u7528\u3002\u6b64\u5916\uff0c\u4f5c\u70ba\u5316\u599d\u54c1\u53ef\u4ee5\u63cf\u8ff0\u7684\u6548\u80fd\u6548\u679c\u7684\u8868\u73fe\u7bc4\u570d\u4e5f\u662f\u6709\u9650\u7684\u3002<\/p>\n\n\n\n<p>\u53c3\u8003\uff1a\u5e73\u621023\u5e74\uff082011\u5e74\uff097\u670821\u65e5\u85e5\u98df\u767c0721\u7b2c1\u865f\u85e5\u52d9\u5c40\u9577\u901a\u77e5\u300c<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/kesyouhin_hanni_20111.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u95dc\u65bc\u5316\u599d\u54c1\u6548\u80fd\u7bc4\u570d\u7684\u4fee\u8a02[ja]<\/a>\u300d<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%86%AB%E7%99%82%E5%99%A8%E6%A2%B0\"><\/span>\u91ab\u7642\u5668\u68b0<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u91ab\u7642\u5668\u68b0\u901a\u5e38\u6307\u7684\u662f\u5982\u624b\u8853\u5200\u6216\u6ce8\u5c04\u5668\u7b49\u91ab\u7642\u7528\u54c1\uff0c\u4f46\u4e26\u4e0d\u50c5\u9650\u65bc\u6b64\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u7684\u300a\u85e5\u6a5f\u6cd5\u300b\uff08Japanese Pharmaceutical and Medical Device Act\uff09\u5728\u7b2c2\u689d\u7b2c4\u9805\u5c0d\u91ab\u7642\u5668\u68b0\u9032\u884c\u4e86\u5b9a\u7fa9\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u5728\u672c\u6cd5\u4e2d\uff0c\u300c\u91ab\u7642\u5668\u68b0\u300d\u6307\u7684\u662f\u7528\u65bc\u4eba\u985e\u6216\u52d5\u7269\u7684\u75be\u75c5\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632\uff0c\u6216\u8005\u5f71\u97ff\u4eba\u985e\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u7684\u6a5f\u68b0\u5668\u5177\u7b49\uff08\u4e0d\u5305\u62ec\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff09\uff0c\u4e26\u7531\u653f\u4ee4\u898f\u5b9a\u3002<\/p>\n<cite>\u300a\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\u300b\u7b2c\u4e8c\u689d\u7b2c\u56db\u9805<\/cite><\/blockquote>\n\n\n\n<p>\u5f9e\u4e0a\u8ff0\u898f\u5b9a\u4e2d\uff0c\u672c\u6240\u53ef\u4ee5\u770b\u51fa\uff0c\u91ab\u7642\u5668\u68b0\u6307\u7684\u662f\u2460\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u7684\u300c\u6a5f\u68b0\u5668\u5177\u7b49\u300d\uff0c\u6216\u8005\u662f\u2461\u7528\u65bc\u8a3a\u65b7\u3001\u6cbb\u7642\u3001\u9810\u9632\u7684\u300c\u6a5f\u68b0\u5668\u5177\u7b49\u300d\uff0c\u4e26\u4e14\u7531\u653f\u4ee4\u898f\u5b9a\u3002<\/p>\n\n\n\n<p>\u300c\u6a5f\u68b0\u5668\u5177\u7b49\u300d\u7684\u5b9a\u7fa9\u5728\u7b2c2\u689d\u7b2c1\u9805\u7b2c2\u865f\u4e2d\uff0c\u5982\u4e0b\u6240\u793a\uff1a<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u6307\u7684\u662f\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\u4e00\u7d50\u679c\u7684\u7d44\u5408\u3002\u4ee5\u4e0b\u540c\u6a23\u3002\uff09\u4ee5\u53ca\u8a18\u9304\u9019\u4e9b\u7684\u8a18\u9304\u5a92\u9ad4\u3002<\/p>\n<cite>\u300a\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\u300b\u7b2c\u4e8c\u689d\u7b2c\u4e00\u9805\u7b2c\u4e8c\u865f<\/cite><\/blockquote>\n\n\n\n<p>\u4f8b\u5982\uff0c\u5065\u8eab\u5668\u6750\u96d6\u7136\u662f\u70ba\u4e86\u589e\u52a0\u808c\u8089\u800c\u8a2d\u8a08\u7684\uff0c\u56e0\u6b64\u5177\u6709\u300c\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u300d\u7684\u76ee\u7684\uff0c\u4f46\u4e26\u975e\u300c\u7531\u653f\u4ee4\u898f\u5b9a\u7684\u6a5f\u68b0\u5668\u5177\u7b49\u300d\uff0c\u56e0\u6b64\u4e0d\u5c6c\u65bc\u91ab\u7642\u5668\u68b0\u3002\u76f8\u53cd\uff0c\u6309\u6469\u5668\u5177\u662f\u300c\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd\u300d\u7684\u300c\u7531\u653f\u4ee4\u898f\u5b9a\u7684\u6a5f\u68b0\u5668\u5177\u7b49\u300d\uff0c\u56e0\u6b64\u5c6c\u65bc\u91ab\u7642\u5668\u68b0\u3002<\/p>\n\n\n\n<p>\u5176\u4ed6\u5177\u9ad4\u7684\u91ab\u7642\u5668\u68b0\u4f8b\u5b50\u5305\u62ec\u9ad4\u6eab\u8a08\u3001\u7e2b\u5408\u7dda\u3001\u907f\u5b55\u7528\u5177\u3001\u75be\u75c5\u8a3a\u65b7\u7a0b\u5e8f\u7b49\u3002<\/p>\n\n\n\n<p>\u6839\u64da\u5176\u5371\u96aa\u6027\u548c\u4f7f\u7528\u76ee\u7684\uff0c\u91ab\u7642\u5668\u68b0\u88ab\u5206\u70ba\u300c\u4e00\u822c\u91ab\u7642\u5668\u68b0\u300d\u3001\u300c\u7ba1\u7406\u91ab\u7642\u5668\u68b0\u300d\u548c\u300c\u9ad8\u5ea6\u7ba1\u7406\u91ab\u7642\u5668\u68b0\u300d\u3002<\/p>\n\n\n\n<p>\u5c0d\u91ab\u7642\u5668\u68b0\u7684\u4e3b\u8981\u898f\u5b9a\u7c21\u55ae\u4f86\u8aaa\uff0c\u5c31\u662f\u95dc\u65bc\u88fd\u9020\u3001\u92b7\u552e\u3001\u79df\u8cc3\u548c\u4fee\u7406\u7684\u8a31\u53ef\u548c\u7533\u5831\u3002\u898f\u5b9a\u7684\u7a0b\u5ea6\u6839\u64da\u91ab\u7642\u5668\u68b0\u7684\u5206\u985e\u800c\u7570\u3002\u4f8b\u5982\uff0c\u5c0d\u65bc\u300c\u9ad8\u5ea6\u7ba1\u7406\u91ab\u7642\u5668\u68b0\u300d\uff0c\u92b7\u552e\u6642\u9700\u8981\u8a31\u53ef\uff0c\u800c\u5c0d\u65bc\u300c\u4e00\u822c\u91ab\u7642\u5668\u68b0\u300d\uff0c\u92b7\u552e\u6642\u4e0d\u9700\u8981\u8a31\u53ef\u6216\u7533\u5831\uff0c\u53ef\u4ee5\u81ea\u7531\u92b7\u552e\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%86%8D%E7%94%9F%E9%86%AB%E7%99%82%E7%AD%89%E7%94%A2%E5%93%81\"><\/span>\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u898f\u7bc4\u662f\u57282014\u5e74\uff08\u897f\u51432014\u5e74\uff09\u7684\u4fee\u8a02\u6642\u8a2d\u7acb\u7684\u5236\u5ea6\u3002\u5982\u5c71\u4e2d\u4f38\u5f4c\u6559\u6388\u7684iPS\u7d30\u80de\u958b\u767c\u6240\u4ee3\u8868\u7684\uff0c\u518d\u751f\u91ab\u7642\u7684\u9032\u6b65\u9a5a\u4eba\uff0c\u7136\u800c\uff0c\u5c0d\u65bc\u5176\u98a8\u96aa\u7684\u4e86\u89e3\u4ecd\u6709\u8a31\u591a\u672a\u77e5\u4e4b\u8655\uff0c\u70ba\u4e86\u5728\u78ba\u4fdd\u5b89\u5168\u6027\u7684\u540c\u6642\u63a8\u9032\u9032\u6b65\uff0c\u672c\u6240\u5f15\u5165\u4e86\u65b0\u7684\u5236\u5ea6\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u85e5\u6a5f\u6cd5\uff08Japanese Pharmaceutical and Medical Device Act\uff09\u5728\u7b2c2\u689d\u7b2c9\u9805\u4e2d\u5c0d\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u9032\u884c\u4e86\u5b9a\u7fa9\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u5728\u672c\u6cd5\u4e2d\uff0c\u300c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u300d\u6307\u7684\u662f\u4ee5\u4e0b\u5217\u51fa\u7684\u7269\u54c1\uff08\u4e0d\u5305\u62ec\u85e5\u54c1\u548c\u5316\u599d\u54c1\uff09\uff0c\u4e26\u7531\u653f\u4ee4\u898f\u5b9a\u3002<\/p>\n\n\n\n<p>\u4e00\u3001\u5728\u4ee5\u4e0b\u5217\u51fa\u7684\u70ba\u91ab\u7642\u6216\u7378\u91ab\u7528\u9014\u7684\u7269\u54c1\u4e2d\uff0c\u5c0d\u4eba\u6216\u52d5\u7269\u7684\u7d30\u80de\u9032\u884c\u57f9\u990a\u6216\u5176\u4ed6\u52a0\u5de5\u7684\u7269\u54c1<\/p>\n\n\n\n<p>\u30a4\u3001\u91cd\u5efa\u3001\u4fee\u5fa9\u6216\u5f62\u6210\u4eba\u6216\u52d5\u7269\u7684\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd<\/p>\n\n\n\n<p>\u30ed\u3001\u6cbb\u7642\u6216\u9810\u9632\u4eba\u6216\u52d5\u7269\u7684\u75be\u75c5<\/p>\n\n\n\n<p>\u4e8c\u3001\u5728\u4ee5\u4e0b\u5217\u51fa\u7684\u70ba\u6cbb\u7642\u4eba\u6216\u52d5\u7269\u7684\u75be\u75c5\u7684\u7269\u54c1\u4e2d\uff0c\u5c07\u907a\u50b3\u57fa\u56e0\u5f15\u5165\u4eba\u6216\u52d5\u7269\u7684\u7d30\u80de\u4e26\u5728\u5176\u9ad4\u5167\u8868\u73fe\u7684\u7269\u54c1<\/p>\n<cite>\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u78ba\u4fdd\u7b49\u76f8\u95dc\u6cd5\u5f8b \u7b2c\u4e8c\u689d\u7b2c\u4e5d\u9805<\/cite><\/blockquote>\n\n\n\n<p>\u5f9e\u4e0a\u8ff0\u898f\u5b9a\u53ef\u4ee5\u770b\u51fa\uff0c\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u5169\u7a2e\u3002\u7b2c\u4e00\u7a2e\u662f\u300c\u5c0d\u4eba\u6216\u52d5\u7269\u7684\u7d30\u80de\u9032\u884c\u57f9\u990a\u6216\u5176\u4ed6\u52a0\u5de5\u7684\u7269\u54c1\u300d\u3002\u7b2c\u4e8c\u7a2e\u662f\u300c\u5c07\u907a\u50b3\u57fa\u56e0\u5f15\u5165\u4eba\u6216\u52d5\u7269\u7684\u7d30\u80de\u4e26\u5728\u5176\u9ad4\u5167\u8868\u73fe\u7684\u7269\u54c1\u300d\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E4%BD%95%E8%AC%82%E3%80%8C%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E4%B8%8A%E7%9A%84%E5%BB%A3%E5%91%8A%E8%A6%8F%E7%AF%84\"><\/span>\u4f55\u8b02\u300c\u85e5\u6a5f\u6cd5\u300d\u4e0a\u7684\u5ee3\u544a\u898f\u7bc4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith-law.jp\/wp-content\/uploads\/2022\/08\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1-3.png\" alt=\"\u85e5\u6a5f\u6cd5\u4e0a\u7684\u5ee3\u544a\u898f\u7bc4\u662f\u4ec0\u9ebc\" class=\"wp-image-49935\" \/><\/figure>\n\n\n\n<p>\u5728\u9019\u88e1\uff0c\u672c\u6240\u5c07\u89e3\u91cb\u4e00\u500b\u7279\u5225\u9700\u8981\u5927\u5bb6\u6ce8\u610f\u7684\u898f\u7bc4\uff0c\u5373\u300c\u85e5\u6a5f\u6cd5\u300d\u4e0a\u7684\u5ee3\u544a\u898f\u7bc4\u3002<\/p>\n\n\n\n<p>\u95dc\u65bc\u85e5\u54c1\u7b49\u7684\u5ee3\u544a\uff0c\u4e00\u65b9\u9762\u6709\u63d0\u4f9b\u4fe1\u606f\u7d66\u570b\u6c11\u7684\u9762\u5411\uff0c\u53e6\u4e00\u65b9\u9762\uff0c\u5982\u679c\u904e\u5ea6\u7684\u5ee3\u544a\u8868\u73fe\u589e\u52a0\uff0c\u53ef\u80fd\u6703\u5c0e\u81f4\u52a3\u8cea\u54c1\u7684\u6d41\u901a\u548c\u5c0d\u5b89\u5168\u6027\u7684\u8aa4\u89e3\uff0c\u5f9e\u800c\u5c0d\u570b\u6c11\u7684\u5065\u5eb7\u9020\u6210\u50b7\u5bb3\u3002\u56e0\u6b64\uff0c\u300c\u85e5\u6a5f\u6cd5\u300d\u5728\u7b2c66\u689d\u81f3\u7b2c68\u689d\u4e2d\u5c0d\u85e5\u54c1\u7b49\u7684\u5ee3\u544a\u9032\u884c\u4e86\u898f\u7bc4\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u4efb\u4f55\u4eba\u90fd\u4e0d\u5f97\u5c0d\u85e5\u54c1\u3001\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u9032\u884c\u660e\u793a\u6216\u6697\u793a\u7684\u865b\u5047\u6216\u8a87\u5927\u7684\u5ee3\u544a\u3001\u63cf\u8ff0\u6216\u6563\u64ad\u3002<\/p>\n\n\n\n<p>2. \u95dc\u65bc\u85e5\u54c1\u3001\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\uff0c\u5982\u679c\u6709\u53ef\u80fd\u88ab\u8aa4\u89e3\u70ba\u91ab\u751f\u7b49\u4eba\u58eb\u4fdd\u8b49\u7684\u6587\u7ae0\uff0c\u5247\u61c9\u8996\u70ba\u865b\u5047\u6216\u8a87\u5927\u7684\u5ee3\u544a\u3001\u63cf\u8ff0\u6216\u6563\u64ad\u3002<\/p>\n\n\n\n<p>3. \u4efb\u4f55\u4eba\u90fd\u4e0d\u5f97\u4f7f\u7528\u6697\u793a\u58ae\u80ce\u6216\u6deb\u7a62\u7684\u6587\u4ef6\u6216\u5716\u756b\u4f86\u63cf\u8ff0\u85e5\u54c1\u3001\u91ab\u85e5\u90e8\u5916\u54c1\u3001\u5316\u599d\u54c1\u3001\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u3002<\/p>\n<cite>\u65e5\u672c\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u78ba\u4fdd\u7b49\u6cd5\u5f8b \u7b2c\u516d\u5341\u516d\u689d<\/cite><\/blockquote>\n\n\n\n<p>\u7b2c66\u689d\u7b2c1\u9805\u898f\u5b9a\u7981\u6b62\u5c0d\u85e5\u54c1\u7b49\u7684\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u9032\u884c\u865b\u5047\u6216\u8a87\u5927\u7684\u5ee3\u544a\u3002\u5982\u679c\u904e\u5ea6\u5ba3\u50b3\u85e5\u54c1\u7684\u529f\u6548\uff0c\u53ef\u80fd\u6703\u5c0e\u81f4\u8aa4\u7528\u7684\u64f4\u5927\uff0c\u751a\u81f3\u53ef\u80fd\u5c0e\u81f4\u75c5\u60c5\u60e1\u5316\u3002\u7b2c66\u689d\u7b2c1\u9805\u5c31\u662f\u70ba\u4e86\u898f\u7bc4\u9019\u7a2e\u5ee3\u544a\u3002<\/p>\n\n\n\n<p>\u9019\u88e1\u6240\u8aaa\u7684\u300c\u5ee3\u544a\u300d\u662f\u6307\u6eff\u8db3\u4ee5\u4e0b\u4e09\u500b\u8981\u6c42\u7684\u4e8b\u7269\u3002\uff08\u53c3\u8003\uff1a\u5e73\u621011\u5e74\uff081999\u5e74\uff099\u670829\u65e5\u91ab\u85e5\u76e3\u7b2c148\u865f\u539a\u751f\u7701\u91ab\u85e5\u5b89\u5168\u5c40\u76e3\u8996\u6307\u5c0e\u8ab2\u9577\u901a\u77e5\u300c<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u85e5\u4e8b\u6cd5\u4e2d\u85e5\u54c1\u7b49\u7684\u5ee3\u544a\u7684\u9069\u7528\u6027[ja]<\/a>\u300d\uff09<\/p>\n\n\n\n<ol>\n<li>\u660e\u78ba\u6709\u5438\u5f15\u5ba2\u6236\uff08\u63d0\u9ad8\u5ba2\u6236\u7684\u8cfc\u8cb7\u610f\u9858\uff09\u7684\u610f\u5716<\/li>\n\n\n\n<li>\u660e\u78ba\u986f\u793a\u7279\u5b9a\u85e5\u54c1\u7b49\u7684\u5546\u54c1\u540d\u7a31<\/li>\n\n\n\n<li>\u4e00\u822c\u4eba\u80fd\u5920\u8a8d\u77e5\u7684\u72c0\u614b<\/li>\n<\/ol>\n\n\n\n<p>\u7b2c66\u689d\u7b2c2\u9805\u898f\u5b9a\uff0c\u5982\u679c\u6709\u53ef\u80fd\u88ab\u8aa4\u89e3\u70ba\u91ab\u751f\u7b49\u4eba\u58eb\u4fdd\u8b49\u85e5\u54c1\u7b49\u7684\u529f\u6548\u3001\u6548\u679c\u7b49\u7684\u6587\u7ae0\uff0c\u5247\u61c9\u8996\u70ba\u865b\u5047\u6216\u8a87\u5927\u7684\u5ee3\u544a\u3002<\/p>\n\n\n\n<p>\u7b2c66\u689d\u7b2c3\u9805\u898f\u5b9a\uff0c\u4e0d\u5f97\u4f7f\u7528\u6697\u793a\u58ae\u80ce\u6216\u6deb\u7a62\u7684\u8868\u9054\u65b9\u5f0f\u4f86\u63cf\u8ff0\u85e5\u54c1\u7b49\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u5c0d\u65bc\u88ab\u898f\u5b9a\u70ba\u7528\u65bc\u6cbb\u7642\u764c\u75c7\u7b49\u7279\u6b8a\u75be\u75c5\u7684\u85e5\u54c1\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff0c\u5982\u679c\u4e0d\u5728\u91ab\u751f\u6216\u7259\u91ab\u7684\u6307\u5c0e\u4e0b\u4f7f\u7528\uff0c\u53ef\u80fd\u6703\u7279\u5225\u5bb9\u6613\u7522\u751f\u5371\u5bb3\uff0c\u539a\u751f\u52de\u52d5\u7701\u53ef\u4ee5\u6307\u5b9a\u8a72\u85e5\u54c1\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff0c\u4e26\u5c0d\u8a72\u85e5\u54c1\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u5ee3\u544a\u9032\u884c\u9650\u5236\uff0c\u4f8b\u5982\u9650\u5236\u91dd\u5c0d\u975e\u91ab\u85e5\u76f8\u95dc\u4eba\u58eb\u7684\u5ee3\u544a\u65b9\u5f0f\u7b49\uff0c\u4ee5\u78ba\u4fdd\u8a72\u85e5\u54c1\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u7684\u6b63\u78ba\u4f7f\u7528\u3002<\/p>\n\n\n\n<p>2. \u539a\u751f\u52de\u52d5\u5927\u81e3\u5728\u5c0b\u6c42\u5236\u5b9a\u6216\u5ee2\u9664\u898f\u5b9a\u7279\u6b8a\u75be\u75c5\u7684\u653f\u4ee4\u7684\u95a3\u8b70\u6642\uff0c\u5fc5\u9808\u4e8b\u5148\u807d\u53d6\u85e5\u4e8b\u30fb\u98df\u54c1\u885b\u751f\u5be9\u8b70\u6703\u7684\u610f\u898b\u3002\u4f46\u662f\uff0c\u5c0d\u65bc\u85e5\u4e8b\u30fb\u98df\u54c1\u885b\u751f\u5be9\u8b70\u6703\u8a8d\u70ba\u662f\u8f15\u5fae\u4e8b\u9805\u7684\u60c5\u6cc1\uff0c\u5247\u4e0d\u5728\u6b64\u9650\u3002<\/p>\n<cite>\u65e5\u672c\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u78ba\u4fdd\u7b49\u6cd5\u5f8b \u7b2c\u516d\u5341\u4e03\u689d<\/cite><\/blockquote>\n\n\n\n<p>\u7b2c67\u689d\u898f\u5b9a\uff0c\u5c0d\u65bc\u7279\u6b8a\u75be\u75c5\u7528\u85e5\uff0c\u570b\u5bb6\u53ef\u4ee5\u5236\u5b9a\u5ee3\u544a\u65b9\u5f0f\u7684\u9650\u5236\u7b49\u63aa\u65bd\u3002\u5be6\u969b\u4e0a\uff0c\u653f\u4ee4\u5df2\u7d93\u7981\u6b62\u4e86\u7528\u65bc\u6cbb\u7642\u764c\u75c7\u3001\u8089\u7624\u3001\u767d\u8840\u75c5\u7b49\u75be\u75c5\u7684\u85e5\u54c1\u7684\u5ee3\u544a\uff08\u85e5\u6a5f\u6cd5\u5be6\u65bd\u898f\u5247\u7b2c228\u689d\u768410\u7b2c1\u9805\uff0c\u9644\u8868\u7b2c\u4e94\uff09\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u4efb\u4f55\u4eba\u90fd\u4e0d\u5f97\u5c0d\u7b2c\u5341\u56db\u689d\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e94\u7b2c\u4e00\u9805\u6216\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e8c\u5341\u4e09\u7b2c\u4e00\u9805\u898f\u5b9a\u7684\u85e5\u54c1\u6216\u91ab\u7642\u5668\u68b0\u6216\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\uff0c\u5982\u679c\u9084\u6c92\u6709\u7372\u5f97\u7b2c\u5341\u56db\u689d\u7b2c\u4e00\u9805\u3001\u7b2c\u5341\u4e5d\u689d\u7684\u4e8c\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e94\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u5341\u4e03\u7b2c\u4e00\u9805\u3001\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u5341\u4e94\u7b2c\u4e00\u9805\u6216\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e09\u5341\u4e03\u7b2c\u4e00\u9805\u7684\u6279\u51c6\u6216\u7b2c\u4e8c\u5341\u4e09\u689d\u7684\u4e8c\u7684\u4e8c\u5341\u4e09\u7b2c\u4e00\u9805\u7684\u8a8d\u8b49\uff0c\u5c31\u5c0d\u5176\u540d\u7a31\u3001\u88fd\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u9032\u884c\u5ee3\u544a\u3002<\/p>\n<cite>\u65e5\u672c\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u7b49\u7684\u54c1\u8cea\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u78ba\u4fdd\u7b49\u6cd5\u5f8b \u7b2c\u516d\u5341\u516b\u689d<\/cite><\/blockquote>\n\n\n\n<p>\u7b2c68\u689d\u898f\u5b9a\u7981\u6b62\u5c0d\u672a\u7372\u6279\u51c6\u7684\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u3001\u518d\u751f\u91ab\u7642\u7b49\u7522\u54c1\u9032\u884c\u5ee3\u544a\u3002\u53ea\u6709\u5728\u7372\u5f97\u6279\u51c6\u5f8c\uff0c\u5176\u529f\u6548\u7b49\u624d\u80fd\u88ab\u516c\u958b\u8a8d\u53ef\uff0c\u56e0\u6b64\uff0c\u5728\u7372\u5f97\u6279\u51c6\u524d\u6a19\u699c\u5176\u529f\u6548\u7b49\u53ef\u80fd\u6703\u5f15\u8d77\u6df7\u4e82\u3002\u7b2c68\u689d\u5c31\u662f\u70ba\u4e86\u898f\u7bc4\u9019\u7a2e\u5ee3\u544a\u3002<\/p>\n\n\n\n<p>\u7279\u5225\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u7981\u6b62\u865b\u5047\u6216\u8a87\u5927\u7684\u5ee3\u544a\uff08\u7b2c66\u689d\uff09\u548c\u7981\u6b62\u5c0d\u672a\u7372\u6279\u51c6\u7684\u85e5\u54c1\u7b49\u9032\u884c\u5ee3\u544a\uff08\u7b2c68\u689d\uff09\u7684\u898f\u5b9a\uff0c\u898f\u7bc4\u7684\u5c0d\u8c61\u662f\u300c\u4efb\u4f55\u4eba\u300d\u3002<\/p>\n\n\n\n<p>\u9019\u4e9b\u898f\u7bc4\u9069\u7528\u65bc\u300c\u4efb\u4f55\u4eba\u300d\uff0c\u4e5f\u5c31\u662f\u300c\u6240\u6709\u4eba\u300d\u3002\u4e0d\u50c5\u9069\u7528\u65bc\u85e5\u54c1\u7b49\u7684\u88fd\u9020\u92b7\u552e\u696d\u8005\u548c\u92b7\u552e\u696d\u8005\uff0c\u4e5f\u9069\u7528\u65bc\u63a5\u53d7\u696d\u8005\u59d4\u8a17\u9032\u884c\u5ee3\u544a\u7684\u60c5\u6cc1\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u96fb\u8996\u3001\u5831\u7d19\u7b49\u5927\u773e\u5a92\u9ad4\uff0c\u5ee3\u544a\u4ee3\u7406\u5546\uff0c\u806f\u76df\u6703\u54e1\uff0c\u5f71\u97ff\u8005\u7b49\u4eba\u5728\u4ecb\u7d39\u85e5\u54c1\u6216\u5316\u599d\u54c1\u7b49\u6642\uff0c\u5fc5\u9808\u6ce8\u610f\u4e0d\u8981\u9055\u53cd\u85e5\u6a5f\u6cd5\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u5373\u4f7f\u662f\u539f\u672c\u4e0d\u5728\u85e5\u6a5f\u6cd5\u898f\u7bc4\u7bc4\u570d\u5167\u7684\u5546\u54c1\uff0c\u4e5f\u53ef\u80fd\u56e0\u70ba\u5176\u8868\u73fe\u5167\u5bb9\u800c\u6210\u70ba\u85e5\u6a5f\u6cd5\u7684\u898f\u7bc4\u5c0d\u8c61\u3002\u9019\u4e00\u9ede\u5c07\u5728\u5f8c\u9762\u7684\u300c\u4e0d\u5728\u85e5\u6a5f\u6cd5\u898f\u7bc4\u7bc4\u570d\u5167\u7684\u7522\u54c1\u300d\u4e2d\u9032\u884c\u89e3\u91cb\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%80%8C%E8%AA%87%E5%A4%A7%E3%80%8D%E6%98%AF%E5%90%A6%E9%81%A9%E7%95%B6%EF%BC%8C%E4%BB%A5%E3%80%8C%E6%97%A5%E6%9C%AC%E8%97%A5%E5%93%81%E7%AD%89%E9%81%A9%E6%AD%A3%E5%BB%A3%E5%91%8A%E5%9F%BA%E6%BA%96%E3%80%8D%E7%82%BA%E5%88%A4%E6%96%B7%E4%BE%9D%E6%93%9A\"><\/span>\u300c\u8a87\u5927\u300d\u662f\u5426\u9069\u7576\uff0c\u4ee5\u300c\u65e5\u672c\u85e5\u54c1\u7b49\u9069\u6b63\u5ee3\u544a\u57fa\u6e96\u300d\u70ba\u5224\u65b7\u4f9d\u64da<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u300c\u865b\u507d\u300d\u6307\u7684\u662f\u8207\u4e8b\u5be6\u4e0d\u7b26\u7684\u60c5\u6cc1\uff0c\u300c\u8a87\u5927\u300d\u5247\u662f\u6307\u4f7f\u7528\u6700\u5927\u7a0b\u5ea6\u7684\u8868\u9054\u3002\u95dc\u65bc\u300c\u865b\u507d\u6216\u8a87\u5927\u300d\u7684\u5224\u65b7\u57fa\u6e96\uff0c\u7531\u65e5\u672c\u539a\u751f\u52de\u52d5\u7701\u5236\u5b9a\u7684\u300c<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179264.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u65e5\u672c\u85e5\u54c1\u7b49\u9069\u6b63\u5ee3\u544a\u57fa\u6e96[ja]<\/a>\u300d\u548c\u300c<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179263.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u65e5\u672c\u85e5\u54c1\u7b49\u9069\u6b63\u5ee3\u544a\u57fa\u6e96\u7684\u89e3\u8aaa\u53ca\u6ce8\u610f\u4e8b\u9805\u7b49[ja]<\/a>\u300d\u4e2d\u6709\u6240\u8aaa\u660e\u3002<\/p>\n\n\n\n<p>\u4f8b\u5982\uff0c\u5c0d\u65bc\u540d\u7a31\uff0c\u5df2\u7d93\u78ba\u7acb\u4e86\u4e00\u500b\u5224\u65b7\u57fa\u6e96\uff0c\u5373\u9664\u4e86\u65e5\u672c\u85e5\u5178\u898f\u5b9a\u7684\u540d\u7a31\u548c\u7533\u5831\u7684\u540d\u7a31\u5916\uff0c\u4e0d\u5f97\u4f7f\u7528\u5176\u4ed6\u540d\u7a31\u3002<\/p>\n\n\n\n<p>\u66f4\u5177\u9ad4\u5730\u8aaa\uff0c\u5c0d\u65bc\u9700\u8981\u6279\u51c6\u7684\u85e5\u54c1\u540d\u7a31\uff0c\u4e0d\u5f97\u5c07\u6f22\u5b57\u66ff\u63db\u70ba\u5e73\u5047\u540d\u6216\u5b57\u6bcd\uff0c\u4e26\u4e14\u5c0d\u65bc\u6548\u80fd\u6548\u679c\uff0c\u4e0d\u5f97\u8d85\u51fa\u7372\u5f97\u6279\u51c6\u7684\u7bc4\u570d\u9032\u884c\u8868\u8ff0\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u9084\u6709\u5176\u4ed6\u5177\u9ad4\u7684\u5224\u65b7\u57fa\u6e96\uff0c\u4f8b\u5982\u5728\u85e5\u7528\u6d17\u9aee\u6c34\u4e2d\uff0c\u4e0d\u80fd\u540c\u6642\u4f7f\u7528\u300c\u4fdd\u6301\u982d\u9aee\u548c\u982d\u76ae\u5065\u5eb7\u300d\u548c\u300c\u4f7f\u982d\u9aee\u67d4\u9806\u300d\u9019\u5169\u7a2e\u8868\u9054\u65b9\u5f0f\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E4%B8%8D%E5%8F%97%E8%97%A5%E6%A9%9F%E6%B3%95%E8%A6%8F%E7%AF%84%E7%9A%84%E7%94%A2%E5%93%81\"><\/span>\u4e0d\u53d7\u85e5\u6a5f\u6cd5\u898f\u7bc4\u7684\u7522\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u53d7\u85e5\u6a5f\u6cd5\u898f\u7bc4\u7684\u5c0d\u8c61\u662f\u4e0a\u8ff0\u7684\u300c\u85e5\u54c1\u7b49\u300d\u3002\u56e0\u6b64\uff0c\u5c0d\u65bc\u4e0d\u5c6c\u65bc\u300c\u85e5\u54c1\u7b49\u300d\u7684\u7522\u54c1\uff0c\u60a8\u53ef\u80fd\u6703\u8a8d\u70ba\u53ef\u4ee5\u4e0d\u7528\u64d4\u5fc3\u85e5\u6a5f\u6cd5\uff0c\u53ef\u4ee5\u81ea\u7531\u5730\u9032\u884c\u92b7\u552e\u548c\u5ee3\u544a\u7b49\u3002<\/p>\n\n\n\n<p>\u7136\u800c\uff0c\u5373\u4f7f\u662f\u672c\u4f86\u4e0d\u5c6c\u65bc\u300c\u85e5\u54c1\u7b49\u300d\u7684\u7522\u54c1\uff0c\u5982\u679c\u5176\u6a19\u793a\u6216\u5ee3\u544a\u5167\u5bb9\u5ba3\u7a31\u5177\u6709\u85e5\u54c1\u822c\u7684\u6548\u80fd\u6548\u679c\uff0c\u5247\u53ef\u80fd\u88ab\u8996\u70ba\u85e5\u54c1\u3002<\/p>\n\n\n\n<p>\u4e00\u65e6\u88ab\u8996\u70ba\u85e5\u54c1\uff0c\u5982\u679c\u6c92\u6709\u4f5c\u70ba\u85e5\u54c1\u7684\u6279\u51c6\uff0c\u6839\u64da\u7b2c68\u689d\uff0c\u5ee3\u544a\u5c07\u88ab\u7981\u6b62\u3002<\/p>\n\n\n\n<p>\u63db\u53e5\u8a71\u8aaa\uff0c\u5373\u4f7f\u662f\u4e0d\u53d7\u85e5\u6a5f\u6cd5\u898f\u7bc4\u7684\u7522\u54c1\uff0c\u5982\u679c\u9032\u884c\u5ba3\u7a31\u5177\u6709\u85e5\u54c1\u822c\u6548\u80fd\u6548\u679c\u7684\u5ee3\u544a\uff0c\u5c07\u6703\u9055\u53cd\u85e5\u6a5f\u6cd5\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u5c0d\u65bc\u50cf\u662f\u5065\u5eb7\u98df\u54c1\u6216\u88dc\u5145\u5291\u9019\u6a23\u7684\u7522\u54c1\uff0c\u7531\u65bc\u5b83\u5011\u53ea\u662f\u98df\u54c1\uff0c\u800c\u4e0d\u662f\u300c\u85e5\u54c1\u7b49\u300d\uff0c\u6240\u4ee5\u4e0d\u5141\u8a31\u5ba3\u7a31\u5177\u6709\u85e5\u54c1\u822c\u7684\u6548\u80fd\u6548\u679c\u3002\u5c0d\u65bc\u5065\u5eb7\u98df\u54c1\u6216\u88dc\u5145\u5291\uff0c\u300c\u9810\u9632\u764c\u75c7\u300d\u3001\u300c\u9632\u6b62\u8870\u8001\u300d\u7b49\u5ee3\u544a\u5c07\u9055\u53cd\u85e5\u6a5f\u6cd5\u3002<\/p>\n\n\n\n<p>\u7136\u800c\uff0c\u5373\u4f7f\u67d0\u7a2e\u5065\u5eb7\u98df\u54c1\u5be6\u969b\u4e0a\u5c0d\u5065\u5eb7\u6709\u76ca\uff0c\u5982\u679c\u4e0d\u5141\u8a31\u9019\u7a2e\u8868\u9054\u65b9\u5f0f\uff0c\u5c07\u7121\u7aef\u963b\u7919\u7522\u54c1\u548c\u4fe1\u606f\u7684\u6d41\u901a\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u5c0d\u65bc\u570b\u5bb6\u5be9\u67e5\u4e26\u8a8d\u53ef\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u90e8\u5206\u98df\u54c1\uff0c\u88ab\u5141\u8a31\u4ee5\u300c\u4fdd\u5065\u529f\u80fd\u98df\u54c1\u300d\u7684\u540d\u7fa9\uff0c\u5728\u570b\u5bb6\u8a8d\u53ef\u7684\u7bc4\u570d\u5167\u9032\u884c\u6548\u80fd\u6548\u679c\u7684\u6a19\u793a\u3002<\/p>\n\n\n\n<p>\u300c\u4fdd\u5065\u529f\u80fd\u98df\u54c1\u300d\u5305\u62ec\uff1a<\/p>\n\n\n\n<ol>\n<li>\u529f\u80fd\u6027\u8868\u793a\u98df\u54c1<\/li>\n\n\n\n<li>\u71df\u990a\u529f\u80fd\u98df\u54c1<\/li>\n\n\n\n<li>\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1<\/li>\n<\/ol>\n\n\n\n<p>\u76f8\u95dc\u6587\u7ae0\uff1a<a href=\"https:\/\/monolith-law.jp\/?p=49842\" target=\"_blank\" rel=\"noreferrer noopener\">\u85e5\u6a5f\u6cd5\u7684\u5ee3\u544a\u898f\u7bc4\u662f\u4ec0\u9ebc\uff1f\u89e3\u91cb\u5982\u4f55\u5275\u4f5c\u5408\u6cd5\u8868\u9054\u7684\u5ee3\u544a\u7684\u8981\u9ede[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%81%95%E5%8F%8D%E3%80%8C%E6%97%A5%E6%9C%AC%E8%97%A5%E6%A9%9F%E6%B3%95%E3%80%8D%E7%9A%84%E7%BD%B0%E5%89%87%E6%98%AF%E4%BB%80%E9%BA%BC\"><\/span>\u9055\u53cd\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u7684\u7f70\u5247\u662f\u4ec0\u9ebc<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/monolith-law.jp\/wp-content\/uploads\/2022\/08\/https___monolith-law.jp_wordpress_wp-admin_post.php_post49834actionedit-rewrite1.png\" alt=\"\u9055\u53cd\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u7684\u7f70\u5247\u662f\u4ec0\u9ebc\" class=\"wp-image-49920\" \/><\/figure>\n\n\n\n<p>\u9055\u53cd\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u7684\u60c5\u6cc1\u4e0b\uff0c\u5c07\u6703\u53d7\u5230\u5211\u4e8b\u7f70\u3002\u6b64\u5916\uff0c\u57282021\u5e74\uff08\u4ee4\u548c3\u5e74\uff09\u5be6\u65bd\u7684\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u6539\u6b63\u6848\u4e2d\uff0c\u65b0\u5f15\u5165\u4e86\u7f70\u6b3e\u5236\u5ea6\u3002<\/p>\n\n\n\n<p>\u7f70\u6b3e\u5236\u5ea6\u662f\u5c0d\u65bc\u9032\u884c\u85e5\u54c1\u7b49\u865b\u507d\u6216\u8a87\u5927\u5ee3\u544a\u7684\u4eba\uff0c\u547d\u4ee4\u5176\u652f\u4ed8\u91d1\u9322\u7684\u5236\u5ea6\u3002\u7f70\u6b3e\u7684\u91d1\u984d\u88ab\u8a2d\u5b9a\u70ba\u4e00\u5b9a\u671f\u9593\u92b7\u552e\u984d\u76844.5%\uff08\u7b2c75\u689d\u4e4b5\u76842\u7b2c1\u9805\uff09\u3002<\/p>\n\n\n\n<p>\u95dc\u65bc\u7f70\u6b3e\u5236\u5ea6\uff0c\u8acb\u53c3\u8003\u4ee5\u4e0b\u6587\u7ae0\u3002<\/p>\n\n\n\n<p>\u76f8\u95dc\u6587\u7ae0\uff1a<a href=\"https:\/\/monolith-law.jp\/?p=49848\" target=\"_blank\" rel=\"noreferrer noopener\">\u65e5\u672c\u85e5\u6a5f\u6cd5\u7684\u7f70\u6b3e\u5236\u5ea6\u662f\u4ec0\u9ebc\uff1f\u89e3\u91cb\u9069\u7528\u884c\u70ba\u548c\u6e1b\u514d\u60c5\u6cc1[ja]<\/a><\/p>\n\n\n\n<p>\u7e3d\u7684\u4f86\u8aaa\uff0c\u5982\u679c\u9032\u884c\u8a87\u5927\u6216\u865b\u507d\u5ee3\u544a\uff0c\u9664\u4e86\u53ef\u80fd\u88ab\u5224\u5211\u5916\uff0c\u9084\u53ef\u80fd\u56e0\u7f70\u6b3e\u800c\u906d\u53d7\u7d93\u6fdf\u640d\u5931\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u9055\u53cd\u300c\u65e5\u672c\u85e5\u6a5f\u6cd5\u300d\u7684\u4e8b\u5be6\u4e0d\u50c5\u53ef\u80fd\u5f15\u767c\u6cd5\u5f8b\u554f\u984c\uff0c\u9084\u53ef\u80fd\u5c0e\u81f4\u884c\u70ba\u8005\u5931\u53bb\u4fe1\u8b7d\uff0c\u9019\u662f\u4e00\u500b\u5de8\u5927\u7684\u98a8\u96aa\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%81%BF%E5%85%8D%E9%81%95%E5%8F%8D%E6%97%A5%E6%9C%AC%E8%97%A5%E4%BA%8B%E6%B3%95%E7%9A%84%E8%A6%81%E9%BB%9E\"><\/span>\u907f\u514d\u9055\u53cd\u65e5\u672c\u85e5\u4e8b\u6cd5\u7684\u8981\u9ede<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u65e5\u672c\u85e5\u4e8b\u6cd5\uff08Japanese Pharmaceutical Affairs Law\uff09\u4e0d\u50c5\u9069\u7528\u65bc\u85e5\u5c40\u7b49\u91ab\u7642\u696d\u754c\uff0c\u4e5f\u9069\u7528\u65bc\u5404\u7a2e\u696d\u754c\u7684\u4f01\u696d\u3002\u70ba\u4e86\u907f\u514d\u9055\u53cd\u65e5\u672c\u85e5\u4e8b\u6cd5\uff0c\u8acb\u78ba\u8a8d\u4ee5\u4e0b\u5169\u500b\u8981\u9ede\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%AD%A3%E7%A2%BA%E7%90%86%E8%A7%A3%E6%8C%87%E5%B0%8E%E6%96%B9%E9%87%9D\"><\/span>\u6b63\u78ba\u7406\u89e3\u6307\u5c0e\u65b9\u91dd<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u70ba\u4e86\u907f\u514d\u9055\u53cd\u65e5\u672c\u85e5\u4e8b\u6cd5\uff0c\u60a8\u9700\u8981\u6b63\u78ba\u7406\u89e3\u60a8\u7684\u7522\u54c1\u662f\u5426\u53d7\u5230\u65e5\u672c\u85e5\u4e8b\u6cd5\u7684\u898f\u7bc4\uff0c\u4ee5\u53ca\u5728\u88fd\u9020\u3001\u92b7\u552e\u3001\u5ee3\u544a\u7b49\u904e\u7a0b\u4e2d\u6703\u53d7\u5230\u54ea\u4e9b\u898f\u5b9a\u7684\u5f71\u97ff\u3002<\/p>\n\n\n\n<p>\u70ba\u6b64\uff0c\u60a8\u9700\u8981\u78ba\u8a8d\u4e0d\u50c5\u8207\u6b64\u76f8\u95dc\u7684\u6cd5\u5f8b\uff0c\u9084\u6709\u65e5\u672c\u539a\u751f\u52de\u52d5\u7701\uff08Japanese Ministry of Health, Labour and 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class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Monolith\u6cd5\u5f8b\u4e8b\u52d9\u6240\u662f\u4e00\u5bb6\u5728IT\uff0c\u7279\u5225\u662f\u4e92\u806f\u7db2\u548c\u6cd5\u5f8b\u5169\u65b9\u9762\u5177\u6709\u9ad8\u5ea6\u5c08\u696d\u6027\u7684\u6cd5\u5f8b\u4e8b\u52d9\u6240\u3002\u672c\u6240\u4e8b\u52d9\u6240\u70ba\u5a92\u9ad4\u71df\u904b\u5546\u3001\u8a55\u8ad6\u7db2\u7ad9\u71df\u904b\u5546\u3001\u5ee3\u544a\u4ee3\u7406\u5546\u3001\u76f4\u63a5\u5c0d\u6d88\u8cbb\u8005\uff08D2C\uff09\u5982\u4fdd\u5065\u54c1\u548c\u5316\u599d\u54c1\u88fd\u9020\u5546\u3001\u8a3a\u6240\u3001\u61c9\u7528\u670d\u52d9\u63d0\u4f9b\u5546\uff08ASP\uff09\u7b49\u63d0\u4f9b\u6587\u7ae0\u548cLP\u7684\u6cd5\u5f8b\u5be9\u67e5\u3001\u6307\u5c0e\u65b9\u91dd\u5236\u5b9a\u548c\u6a23\u54c1\u6aa2\u67e5\u7b49\u670d\u52d9\u3002\u8a73\u7d30\u5167\u5bb9\u8acb\u53c3\u898b\u4e0b\u6587\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/monolith.law\/operationofmedia\" target=\"_blank\" rel=\"noreferrer 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[&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":68412,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[30,24],"acf":[],"_links":{"self":[{"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/posts\/67234"}],"collection":[{"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/comments?post=67234"}],"version-history":[{"count":2,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/posts\/67234\/revisions"}],"predecessor-version":[{"id":68413,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/posts\/67234\/revisions\/68413"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/media\/68412"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/media?parent=67234"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/categories?post=67234"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/zh-tw\/wp-json\/wp\/v2\/tags?post=67234"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}