{"id":63157,"date":"2024-05-02T12:15:50","date_gmt":"2024-05-02T03:15:50","guid":{"rendered":"https:\/\/monolith.law\/zh-cn\/?p=63157"},"modified":"2024-05-19T14:25:28","modified_gmt":"2024-05-19T05:25:28","slug":"pharmaceutical-law-penalties","status":"publish","type":"post","link":"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceutical-law-penalties","title":{"rendered":"\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u4f1a\u88ab\u902e\u6355\u5417?\u89e3\u6790\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u53cd\u7684\u5904\u7f5a"},"content":{"rendered":"\n<p>\u5728\u65e5\u672c\u7684\u300a\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Japanese Pharmaceutical and Medical Device 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class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%80%AE%E6%8D%95%E7%9A%84%E7%90%86%E7%94%B1\"><\/span>\u902e\u6355\u7684\u7406\u7531<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u902e\u6355\u7684\u7406\u7531\u662f\u6307\u201c\u6709\u8db3\u591f\u7684\u7406\u7531\u6000\u7591\u72af\u7f6a\u201d\uff08\u5211\u4e8b\u8bc9\u8bbc\u6cd5\u7b2c199\u6761\u7b2c2\u6b3e\uff09\u3002\u5bf9\u4e8e\u7279\u5b9a\u7684\u72af\u7f6a\u884c\u4e3a\uff0c\u4ec5\u4ec5\u53ef\u80fd\u6027\u5b58\u5728\u662f\u4e0d\u591f\u7684\uff0c\u5373\u4f7f\u6ca1\u6709\u8fbe\u5230\u786e\u4fe1\uff0c\u53ea\u8981\u6709\u76f8\u5f53\u7684\u5acc\u7591\uff0c\u5c31\u53ef\u4ee5\u8ba4\u5b9a\u4e3a\u902e\u6355\u7684\u7406\u7531\u3002<\/p>\n\n\n\n<p>\u5982\u679c\u8fdb\u884c\u4e86\u8fdd\u53cd\u836f\u54c1\u673a\u68b0\u6cd5\u7684\u884c\u4e3a\uff0c\u7531\u4e8e\u72af\u7f6a\u884c\u4e3a\u5df2\u7ecf\u660e\u786e\uff0c\u902e\u6355\u7684\u7406\u7531\u81ea\u7136\u4f1a\u88ab\u8ba4\u5b9a\u3002<\/p>\n\n\n\n<h3 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class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%BF%9D%E5%8F%8D%E8%8D%AF%E6%A2%B0%E6%B3%95%E7%9A%84%E8%A1%8C%E4%B8%BA%E5%8F%8A%E5%85%B6%E5%A4%84%E7%BD%9A%E7%A4%BA%E4%BE%8B\"><\/span>\u8fdd\u53cd\u836f\u68b0\u6cd5\u7684\u884c\u4e3a\u53ca\u5176\u5904\u7f5a\u793a\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh4.googleusercontent.com\/l6A2sj-9ZzoTyhGb0NEaMBV7cFqb-6mrf907WO176CyLNUxxp7j7sI736Sl8jJqf9HBTDztRNG_Z3DRa7kGF7NJeyhwAfNemUE-dMhjClgUnkPvz2xFCkWofKvjBPU_kQqc2UtF_Vxp_fYQ5hTeNifR5sdhmaJGqTOU2f_EEQDLf78sw6Ow1zvt9-1kS0g\" alt=\"\u8fdd\u53cd\u836f\u68b0\u6cd5\u7684\u884c\u4e3a\u53ca\u5176\u5904\u7f5a\u793a\u4f8b\" 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class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%8D%AF%E6%A2%B0%E6%B3%95%E4%B8%AD%E7%9A%84%E8%99%9A%E5%81%87%E8%A1%A8%E7%A4%BA%E6%88%96%E5%A4%B8%E5%A4%A7%E8%A1%A8%E7%A4%BA\"><\/span>\u836f\u68b0\u6cd5\u4e2d\u7684\u865a\u5047\u8868\u793a\u6216\u5938\u5927\u8868\u793a<span 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href=\"https:\/\/monolith-law.jp\/corporate\/pharmaceuticals-law-surcharge\" target=\"_blank\" rel=\"noreferrer noopener\">\u836f\u68b0\u6cd5\u7684\u7f5a\u6b3e\u5236\u5ea6\u662f\u4ec0\u4e48\uff1f\u89e3\u91ca\u9002\u7528\u884c\u4e3a\u548c\u51cf\u514d\u60c5\u51b5[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%BF%9D%E5%8F%8D%E3%80%8A%E6%97%A5%E6%9C%AC%E8%8D%AF%E5%93%81%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E6%B3%95%E3%80%8B%E7%9A%84%E6%A1%88%E4%BE%8B\"><\/span>\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u6848\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh6.googleusercontent.com\/egI2EU7rFLc4zGOz3E1suVDwI-4yW0i9dfW4QJa8xMj_SrgkixK1r4onlcZkXpqOg_COSejSkM5K-IiZOJY3MSFxochawZIGlaARvXMT3xwigvYMgX1Pgi-feGqLsBw6epc-GOZjhKHW40LTpzgGLpvyIje2Gfpdp0PURRFEB7k3rnjQ8NBIiWE1kFi8Cg\" alt=\"\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u6848\u4f8b\" \/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%96%B0%E5%86%A0%E7%97%85%E6%AF%92%E6%8A%97%E5%8E%9F%E6%A3%80%E6%B5%8B%E5%A5%97%E4%BB%B6%E6%9C%AA%E7%BB%8F%E8%AE%B8%E5%8F%AF%E9%94%80%E5%94%AE%E7%9A%84%E6%A1%88%E4%BE%8B\"><\/span>\u65b0\u51a0\u75c5\u6bd2\u6297\u539f\u68c0\u6d4b\u5957\u4ef6\u672a\u7ecf\u8bb8\u53ef\u9500\u552e\u7684\u6848\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u5728\u4e0e\u65b0\u51a0\u75c5\u6bd2\u611f\u67d3\u6269\u5927\u6709\u5173\u7684\u6848\u4f8b\u4e2d\uff0c\u4e8e2021\u5e74\uff08\u4ee4\u548c3\u5e74\uff099\u6708\uff0c\u672a\u7ecf\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u6279\u51c6\u7684\u65b0\u51a0\u75c5\u6bd2\u6297\u539f\u68c0\u6d4b\u5957\u4ef6\u88ab\u5e7f\u544a\u4e3a\u611f\u67d3\u5224\u65ad\u7528\u5e76\u9500\u552e\uff0c\u76f8\u5173\u4eba\u5458\u88ab\u902e\u6355\u3002<\/p>\n\n\n\n<p>\u5728\u8fd9\u4e2a\u6848\u4f8b\u4e2d\uff0c\u95ee\u9898\u5728\u4e8e\u672a\u7ecf\u8bb8\u53ef\u9500\u552e\u533b\u836f\u54c1\u7b49\u7684\u6297\u539f\u68c0\u6d4b\u5957\u4ef6\uff0c\u4ee5\u53ca\u8fdd\u53cd\u4e86\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7b2c68\u6761\uff0c\u5373\u7981\u6b62\u5e7f\u544a\u672a\u7ecf\u539a\u751f\u52b3\u52a8\u5927\u81e3\u6279\u51c6\u7684\u533b\u836f\u54c1\u7b49\u3002<\/p>\n\n\n\n<p>\u88ab\u902e\u6355\u7684\u4e24\u4eba\u57282022\u5e74\uff08\u4ee4\u548c4\u5e74\uff092\u6708\u88ab\u4e0b\u8fbe\u7f5a\u6b3e\u7684\u7b80\u6613\u547d\u4ee4\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%A1%A5%E5%85%85%E5%89%82%E5%B9%BF%E5%91%8A%E8%BF%9D%E5%8F%8D%E6%9C%AA%E6%89%B9%E5%87%86%E5%8C%BB%E8%8D%AF%E5%93%81%E7%AD%89%E7%9A%84%E5%B9%BF%E5%91%8A%E7%A6%81%E6%AD%A2%E7%9A%84%E6%A1%88%E4%BE%8B\"><\/span>\u8865\u5145\u5242\u5e7f\u544a\u8fdd\u53cd\u672a\u6279\u51c6\u533b\u836f\u54c1\u7b49\u7684\u5e7f\u544a\u7981\u6b62\u7684\u6848\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u57282020\u5e74\uff08\u4ee4\u548c2\u5e74\uff097\u6708\uff0c\u5173\u4e8e\u672a\u4f5c\u4e3a\u533b\u836f\u54c1\u6279\u51c6\u7684\u8865\u5145\u5242\uff0c\u56e0\u5728\u5e7f\u544a\u4e2d\u663e\u793a\u201c\u5bf9\u9884\u9632\u809d\u75c5\u6709\u6548\u201d\u7b49\u5185\u5bb9\u5e76\u9500\u552e\uff0c\u9500\u552e\u516c\u53f8\u53ca\u5176\u5458\u5de5\u3001\u5e7f\u544a\u4ee3\u7406\u516c\u53f8\u53ca\u5176\u5458\u5de5\u3001\u5e7f\u544a\u5236\u4f5c\u516c\u53f8\u53ca\u5176\u5458\u5de5\u88ab\u902e\u6355\u3002<\/p>\n\n\n\n<p>\u8fd9\u4e2a\u6848\u4f8b\u4e0e\u7b2c\u4e00\u4e2a\u6848\u4f8b\u4e00\u6837\uff0c\u95ee\u9898\u5728\u4e8e\u8fdd\u53cd\u4e86\u672a\u6279\u51c6\u7684\u533b\u836f\u54c1\u7b49\u7684\u5e7f\u544a\u7981\u6b62\uff0c\u4ee5\u53ca\u8fdd\u53cd\u4e86\u672a\u6279\u51c6\u7684\u533b\u836f\u54c1\u7b49\u7684\u9500\u552e\u7981\u6b62\uff08\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7b2c55\u6761\uff09\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u8fd9\u4e2a\u6848\u4f8b\u7684\u7279\u70b9\u5728\u4e8e\uff0c\u4e0d\u4ec5\u5e7f\u544a\u4e3b\u88ab\u902e\u6355\uff0c\u5e7f\u544a\u4ee3\u7406\u516c\u53f8\u548c\u5e7f\u544a\u5236\u4f5c\u516c\u53f8\u4e5f\u88ab\u902e\u6355\uff0c\u4e25\u683c\u5e94\u7528\u4e86\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7b2c68\u6761\u7684\u201c\u4efb\u4f55\u4eba\u90fd\u4e0d\u5f97\u2026\u2026\u8fdb\u884c\u5e7f\u544a\u201d\u7684\u89c4\u5b9a\u3002<\/p>\n\n\n\n<p>\u5bf9\u4e8e\u8fd9\u4e2a\u6848\u4f8b\uff0c2021\u5e74\uff08\u4ee4\u548c3\u5e74\uff093\u6708\u4e0b\u8fbe\u4e86\u5bf9\u8fdd\u53cd\u672a\u6279\u51c6\u7684\u533b\u836f\u54c1\u7b49\u7684\u5e7f\u544a\u7981\u6b62\u7684\u7f5a\u6b3e\u7684\u7b80\u6613\u547d\u4ee4\uff0c\u5bf9\u4e8e\u8fdd\u53cd\u672a\u6279\u51c6\u7684\u533b\u836f\u54c1\u7b49\u7684\u9500\u552e\u7981\u6b62\uff0c\u5df2\u7ecf\u505a\u51fa\u4e86\u4e0d\u8d77\u8bc9\u5904\u7406\u3002<\/p>\n\n\n\n<p>\u5173\u4e8e\u8fd9\u4e9b\u6848\u4f8b\u4e2d\u51fa\u73b0\u7684\u5e7f\u544a\u89c4\u5b9a\u95ee\u9898\uff0c\u8bf7\u53c2\u8003\u5176\u4ed6\u6587\u7ae0\u3002<\/p>\n\n\n\n<p>\u76f8\u5173\u6587\u7ae0\uff1a<a href=\"https:\/\/monolith-law.jp\/corporate\/pharmaceuticals-advertising-regulations\" target=\"_blank\" rel=\"noreferrer noopener\">\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u5e7f\u544a\u89c4\u5b9a\u662f\u4ec0\u4e48\uff1f\u89e3\u91ca\u5982\u4f55\u5408\u6cd5\u5730\u521b\u5efa\u5e7f\u544a[ja]<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%A6%82%E4%BD%95%E9%98%B2%E6%AD%A2%E5%9B%A0%E8%BF%9D%E5%8F%8D%E3%80%8A%E6%97%A5%E6%9C%AC%E8%8D%AF%E5%93%81%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E6%B3%95%E3%80%8B%E8%80%8C%E8%A2%AB%E9%80%AE%E6%8D%95\"><\/span>\u5982\u4f55\u9632\u6b62\u56e0\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u800c\u88ab\u902e\u6355<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/lh4.googleusercontent.com\/6LBCcWhuGXWL_7GTltWMXAtk8qIuaIBxuer_9l9xY9RzeUnwtzFadr1CUroPMFMVBCWDjB-Ffpcnok7Q1QQ4fHJtlp6d-NSKnnoy5MfWRbTGOcwPly-SjVn1JvJWn-Stvg3_QGPrLbjNktMtneu5Z6ixEcXjYZmvH-MgerUb0g5QqudnAf5JWA1Uu5KymA\" alt=\"\u5982\u4f55\u9632\u6b62\u56e0\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u800c\u88ab\u902e\u6355\" \/><\/figure>\n\n\n\n<p>\u5982\u679c\u8fdd\u53cd\u4e86\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Japanese Pharmaceutical and Medical Device Act\uff09\uff0c\u4e0d\u80fd\u5426\u8ba4\u6709\u53ef\u80fd\u4f1a\u88ab\u902e\u6355\u3002\u4e3a\u4e86\u9632\u6b62\u88ab\u902e\u6355\uff0c\u6211\u4eec\u53ea\u80fd\u5c3d\u91cf\u907f\u514d\u8fdd\u53cd\u8be5\u6cd5\u3002<\/p>\n\n\n\n<p>\u90a3\u4e48\uff0c\u6211\u4eec\u5e94\u8be5\u5982\u4f55\u907f\u514d\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u5462\uff1f<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E7%A1%AE%E8%AE%A4%E8%AE%B8%E5%8F%AF%E5%92%8C%E6%89%B9%E5%87%86%E7%9A%84%E5%86%85%E5%AE%B9%EF%BC%8C%E6%A3%80%E6%9F%A5%E6%8C%87%E5%8D%97\"><\/span>\u786e\u8ba4\u8bb8\u53ef\u548c\u6279\u51c6\u7684\u5185\u5bb9\uff0c\u68c0\u67e5\u6307\u5357<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u9996\u5148\uff0c\u5982\u679c\u60a8\u7684\u516c\u53f8\u4ece\u4e8b\u836f\u54c1\u7b49\u7684\u5236\u9020\u9500\u552e\u4e1a\u52a1\u6216\u5236\u9020\u4e1a\u52a1\uff0c\u60a8\u9700\u8981\u786e\u8ba4\u662f\u5426\u5df2\u7ecf\u83b7\u5f97\u4e86\u9002\u5f53\u7684\u8bb8\u53ef\u3002\u7136\u540e\uff0c\u60a8\u9700\u8981\u786e\u8ba4\u60a8\u7684\u516c\u53f8\u7684\u836f\u54c1\u7b49\u4ea7\u54c1\u662f\u5426\u5df2\u7ecf\u83b7\u5f97\u4e86\u9002\u5f53\u7684\u6279\u51c6\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u5982\u679c\u60a8\u5728\u9500\u552e\u836f\u54c1\u7b49\u4ea7\u54c1\u65f6\u8fdb\u884c\u4e86\u5e7f\u544a\uff0c\u60a8\u5fc5\u987b\u786e\u8ba4\u662f\u5426\u8fdd\u53cd\u4e86\u5e7f\u544a\u89c4\u5b9a\u3002\u5173\u4e8e\u5e7f\u544a\u89c4\u5b9a\u7684\u5185\u5bb9\u548c\u6807\u51c6\uff0c\u65e5\u672c\u539a\u751f\u52b4\u50cd\u7701\u5df2\u7ecf\u6574\u7406\u4e86\u6307\u5357\u7b49\uff0c\u60a8\u5e94\u8be5\u4e86\u89e3\u8fd9\u4e9b\u5185\u5bb9\u3002<\/p>\n\n\n\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/kenkou_iryou\/iyakuhin\/koukokukisei\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u836f\u54c1\u7b49\u7684\u5e7f\u544a\u89c4\u5b9a\uff5c\u65e5\u672c\u539a\u751f\u52b4\u50cd\u7701[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%88%B6%E5%AE%9A%E6%89%8B%E5%86%8C\"><\/span>\u5236\u5b9a\u624b\u518c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u4e86\u89e3\u4e86\u6307\u5357\u7684\u5185\u5bb9\u540e\uff0c\u60a8\u53ef\u4ee5\u901a\u8fc7\u5236\u5b9a\u516c\u53f8\u5185\u90e8\u624b\u518c\u6765\u786e\u4fdd\u4e0d\u8fdd\u53cd\u8fd9\u4e9b\u6307\u5357\uff0c\u4ece\u800c\u4f7f\u5168\u516c\u53f8\u4e86\u89e3\u54ea\u4e9b\u884c\u4e3a\u4f1a\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff0c\u4ee5\u53ca\u5982\u4f55\u907f\u514d\u8fdd\u53cd\u8be5\u6cd5\u3002<\/p>\n\n\n\n<p>\u5982\u540c\u6211\u4eec\u5728\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u4e2d\u6240\u4ecb\u7ecd\u7684\uff0c\u4e0d\u4ec5\u5e7f\u544a\u4e3b\uff0c\u751a\u81f3\u5e7f\u544a\u4ee3\u7406\u5546\u548c\u5e7f\u544a\u5236\u4f5c\u516c\u53f8\u4e5f\u6709\u53ef\u80fd\u88ab\u902e\u6355\uff0c\u56e0\u6b64\uff0c\u60a8\u4e5f\u5e94\u8be5\u8ba9\u60a8\u7684\u4ea4\u6613\u5bf9\u624b\u516c\u53f8\u4e86\u89e3\u8fd9\u4e2a\u624b\u518c\uff0c\u6216\u8005\u786e\u8ba4\u4ed6\u4eec\u662f\u5426\u5df2\u7ecf\u91c7\u53d6\u4e86\u76f8\u5e94\u7684\u63aa\u65bd\uff0c\u8fd9\u5c06\u6709\u52a9\u4e8e\u964d\u4f4e\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u98ce\u9669\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%92%A8%E8%AF%A2%E5%BE%8B%E5%B8%88\"><\/span>\u54a8\u8be2\u5f8b\u5e08<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u7136\u800c\uff0c\u5373\u4f7f\u91c7\u53d6\u4e86\u8fd9\u4e9b\u63aa\u65bd\uff0c\u6211\u4eec\u81ea\u5df1\u5224\u65ad\u4e2a\u522b\u884c\u4e3a\u662f\u5426\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u4e5f\u662f\u76f8\u5f53\u56f0\u96be\u7684\u3002\u6b64\u5916\uff0c\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7ecf\u5e38\u8fdb\u884c\u91cd\u5927\u4fee\u8ba2\uff0c\u56e0\u6b64\uff0c\u6b63\u786e\u7406\u89e3\u4fee\u8ba2\u6cd5\u7684\u5185\u5bb9\u4e5f\u662f\u5fc5\u8981\u7684\u3002<\/p>\n\n\n\n<p>\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u60a8\u5e94\u8be5\u54a8\u8be2\u6709\u4e30\u5bcc\u7ecf\u9a8c\u7684\u5f8b\u5e08\uff0c\u8ba9\u4ed6\u4eec\u5224\u65ad\u60a8\u7684\u884c\u4e3a\u662f\u5426\u8fdd\u53cd\u4e86\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%80%BB%E7%BB%93%EF%BC%9A%E8%8D%AF%E6%A2%B0%E6%B3%95%E9%97%AE%E9%A2%98%E8%AF%B7%E5%92%A8%E8%AF%A2%E5%BE%8B%E5%B8%88\"><\/span>\u603b\u7ed3\uff1a\u836f\u68b0\u6cd5\u95ee\u9898\u8bf7\u54a8\u8be2\u5f8b\u5e08<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u9664\u4e86\u672c\u6587\u4ecb\u7ecd\u7684\u5185\u5bb9\uff0c\u836f\u68b0\u6cd5\u8fd8\u8bbe\u6709\u8bb8\u591a\u89c4\u5b9a\uff0c\u8981\u5224\u65ad\u54ea\u4e9b\u884c\u4e3a\u8fdd\u53cd\u4e86\u836f\u68b0\u6cd5\uff0c\u9700\u8981\u5bf9\u836f\u68b0\u6cd5\u6709\u51c6\u786e\u7684\u7406\u89e3\u3002\u4e2a\u4eba\u6216\u516c\u53f8\u53ef\u80fd\u96be\u4ee5\u51c6\u786e\u638c\u63e1\u6cd5\u5f8b\u7684\u5185\u5bb9\u548c\u8fd0\u7528\uff0c\u56e0\u6b64\uff0c\u5982\u679c\u51fa\u73b0\u4e86\u4e0e\u836f\u68b0\u6cd5\u76f8\u5173\u7684\u95ee\u9898\uff0c\u6216\u8005\u4e3a\u4e86\u9884\u9632\u95ee\u9898\u7684\u53d1\u751f\uff0c\u9996\u5148\u8bf7\u54a8\u8be2\u7ecf\u9a8c\u4e30\u5bcc\u7684\u5f8b\u5e08\u3002<\/p>\n\n\n\n<p>\u836f\u68b0\u6cd5\u7b49\u6cd5\u5f8b\u5ba1\u67e5\u548c\u4fee\u6539\u8868\u8fbe\u7684\u5efa\u8bae\u662f\u4e00\u4e2a\u975e\u5e38\u4e13\u4e1a\u7684\u9886\u57df\u3002Monolith\u5f8b\u5e08\u4e8b\u52a1\u6240\u5df2\u7ecf\u7ec4\u5efa\u4e86\u836f\u68b0\u6cd5\u6cd5\u52a1\u56e2\u961f\uff0c\u53ef\u4ee5\u5e94\u5bf9\u4ece\u4fdd\u5065\u54c1\u5230\u533b\u836f\u54c1\u7b49\u5404\u79cd\u5546\u54c1\u7684\u6587\u7ae0\u68c0\u67e5\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%88%91%E5%80%91%E4%BA%8B%E5%8B%99%E6%89%80%E7%9A%84%E5%B0%8D%E7%AD%96%E4%BB%8B%E7%B4%B9\"><\/span>\u6211\u5011\u4e8b\u52d9\u6240\u7684\u5c0d\u7b56\u4ecb\u7d39<span 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\u90fd\u6709\u8c50\u5bcc\u7d93\u9a57\u7684\u6cd5\u5f8b\u4e8b\u52d9\u6240\u3002\u6211\u5011\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\u9762\u5411\u6d88\u8cbb\u8005\u7684\u71df\u990a\u88dc\u5145\u5291\u548c\u5316\u599d\u54c1\u88fd\u9020\u5546\u3001\u8a3a\u6240\u3001\u61c9\u7528\u670d\u52d9\u63d0\u4f9b\u5546\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>Monolith\u6cd5\u5f8b\u4e8b\u52d9\u6240\u7684\u696d\u52d9\u7bc4\u7587\uff1a<a href=\"https:\/\/monolith-law.jp\/operationofmedia\" target=\"_blank\" rel=\"noreferrer noopener\">\u6587\u7ae0\u30fbLP\u7684\u85e5\u6a5f\u6cd5\u7b49\u6aa2\u67e5[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5728\u65e5\u672c\u7684\u300a\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Japanese Pharmaceutical and Medical Device Act\uff09\u4e2d\uff0c\u89c4\u5b9a\u4e86\u5173\u4e8e\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7b49\u7684\u5404\u79cd\u89c4\u5b9a\u3002\u5982\u679c\u8fdd\u53cd\u8fd9\u4e9b\u89c4\u5b9a\uff0c\u53ef\u80fd\u4f1a\u9762\u4e34\u88ab\u902e\u6355\u7684\u98ce\u9669\uff0c\u6b64\u5916\uff0c\u8fd8\u53ef\u80fd\u4f1a\u88ab\u5904\u4ee5\u7f5a\u6b3e\u6216\u5f81\u6536\u7f5a\u6b3e\uff0c\u8fd9\u53ef\u80fd\u4f1a\u5bf9\u4f01\u4e1a\u9020\u6210\u91cd\u5927\u635f\u5931\u3002 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