{"id":63173,"date":"2024-05-02T12:16:30","date_gmt":"2024-05-02T03:16:30","guid":{"rendered":"https:\/\/monolith.law\/zh-cn\/?p=63173"},"modified":"2024-05-18T22:16:46","modified_gmt":"2024-05-18T13:16:46","slug":"pharmaceuticals-law-penalties","status":"publish","type":"post","link":"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties","title":{"rendered":"\u300a\u65e5\u672c\u836f\u54c1\u673a\u68b0\u6cd5\u300b\u4e2d\u7684\u7f5a\u5219\u548c\u902e\u6355\u6761\u4ef6\u662f\u4ec0\u4e48?\u4e5f\u89e3\u91ca\u4e86\u907f\u514d\u7684\u8981\u70b9"},"content":{"rendered":"\n<p>\u5728\u5236\u836f\u516c\u53f8\u548c\u836f\u5e97\u7b49\u7ecf\u8425\u533b\u836f\u54c1\u7b49\u4ea7\u54c1\u7684\u4f01\u4e1a\u4e2d\uff0c\u65e5\u5e38\u90fd\u4f1a\u8fdb\u884c\u65e5\u672c\u836f\u4e8b\u6cd5\uff08Japanese Pharmaceutical Affairs Law\uff09\u7684\u68c0\u67e5\uff0c\u4f46\u662f\uff0c\u53d7\u836f\u4e8b\u6cd5\u89c4\u5b9a\u7684\u5e76\u4e0d\u4ec5\u9650\u4e8e\u8fd9\u4e9b\u4f01\u4e1a\u3002\u7531\u4e8e\u5176\u89c4\u5b9a\u8303\u56f4\u5e7f\u6cdb\uff0c\u56e0\u6b64\u4e5f\u6709\u4e0d\u77e5\u9053\u81ea\u5df1\u662f\u53d7\u89c4\u5b9a\u5bf9\u8c61\u800c\u8fdd\u53cd\u836f\u4e8b\u6cd5\u7684\u60c5\u51b5\u3002<\/p>\n\n\n\n<p>\u672c\u6587\u5c06\u8be6\u7ec6\u89e3\u91ca\u5982\u4f55\u907f\u514d\u610f\u5916\u8fdd\u53cd\u836f\u4e8b\u6cd5\uff0c\u4ee5\u53ca\u8fdd\u53cd\u6cd5\u89c4\u540e\u7684\u5904\u7f5a\u548c\u907f\u514d\u8fdd\u89c4\u7684\u8981\u70b9\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-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E4%BD%95%E4%B8%BA%E2%80%9C%E8%8D%AF%E6%9C%BA%E6%B3%95%E2%80%9D\" title=\"\u4f55\u4e3a\u201c\u836f\u673a\u6cd5\u201d\">\u4f55\u4e3a\u201c\u836f\u673a\u6cd5\u201d<\/a><ul class='ez-toc-list-level-3'><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E8%8D%AF%E6%9C%BA%E6%B3%95%E7%9A%84%E7%9B%AE%E7%9A%84\" title=\"\u836f\u673a\u6cd5\u7684\u76ee\u7684\">\u836f\u673a\u6cd5\u7684\u76ee\u7684<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E9%9C%80%E8%A6%81%E6%B3%A8%E6%84%8F%E7%9A%84%E8%A7%84%E5%AE%9A%EF%BC%9A%E9%94%80%E5%94%AE%E5%92%8C%E5%B9%BF%E5%91%8A\" 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class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E8%8D%AF%E6%9C%BA%E6%B3%95%E7%9A%84%E5%B9%BF%E5%91%8A%E8%A7%84%E5%AE%9A\" title=\"\u836f\u673a\u6cd5\u7684\u5e7f\u544a\u89c4\u5b9a\">\u836f\u673a\u6cd5\u7684\u5e7f\u544a\u89c4\u5b9a<\/a><ul class='ez-toc-list-level-4'><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E8%BF%9D%E5%8F%8D%E5%B9%BF%E5%91%8A%E7%9A%84%E5%88%A4%E6%96%AD%E6%A0%87%E5%87%86\" title=\"\u8fdd\u53cd\u5e7f\u544a\u7684\u5224\u65ad\u6807\u51c6\">\u8fdd\u53cd\u5e7f\u544a\u7684\u5224\u65ad\u6807\u51c6<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E8%BF%9D%E5%8F%8D%E3%80%8A%E6%97%A5%E6%9C%AC%E8%8D%AF%E5%93%81%E5%92%8C%E5%8C%BB%E7%96%97%E8%AE%BE%E5%A4%87%E6%B3%95%E3%80%8B%E7%9A%84%E5%B9%BF%E5%91%8A%E7%A4%BA%E4%BE%8B\" title=\"\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u8bbe\u5907\u6cd5\u300b\u7684\u5e7f\u544a\u793a\u4f8b\">\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u8bbe\u5907\u6cd5\u300b\u7684\u5e7f\u544a\u793a\u4f8b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E6%A1%88%E4%BE%8B1%EF%BC%9A%E5%8C%96%E5%A6%86%E5%93%81\" title=\"\u6848\u4f8b1\uff1a\u5316\u5986\u54c1\">\u6848\u4f8b1\uff1a\u5316\u5986\u54c1<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" 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class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E9%80%AE%E6%8D%95%E6%9D%A1%E4%BB%B6\" title=\"\u902e\u6355\u6761\u4ef6\">\u902e\u6355\u6761\u4ef6<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E9%81%BF%E5%85%8D%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%E8%A6%81%E7%82%B9\" title=\"\u907f\u514d\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u8981\u70b9\">\u907f\u514d\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u8981\u70b9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%E6%80%BB%E7%BB%93%EF%BC%9A%E5%A6%82%E6%9E%9C%E6%8B%85%E5%BF%83%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%EF%BC%88Pharmaceuticals_and_Medical_Devices_Act%EF%BC%89%EF%BC%8C%E5%B0%B1%E5%BA%94%E5%92%A8%E8%AF%A2%E5%BE%8B%E5%B8%88\" title=\"\u603b\u7ed3\uff1a\u5982\u679c\u62c5\u5fc3\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Pharmaceuticals and Medical Devices Act\uff09\uff0c\u5c31\u5e94\u54a8\u8be2\u5f8b\u5e08\">\u603b\u7ed3\uff1a\u5982\u679c\u62c5\u5fc3\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Pharmaceuticals and Medical Devices Act\uff09\uff0c\u5c31\u5e94\u54a8\u8be2\u5f8b\u5e08<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/monolith.law\/zh-cn\/general-corporate\/pharmaceuticals-law-penalties\/#%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\" title=\"\u6211\u5011\u4e8b\u52d9\u6240\u7684\u5c0d\u7b56\u4ecb\u7d39\">\u6211\u5011\u4e8b\u52d9\u6240\u7684\u5c0d\u7b56\u4ecb\u7d39<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E4%BD%95%E4%B8%BA%E2%80%9C%E8%8D%AF%E6%9C%BA%E6%B3%95%E2%80%9D\"><\/span>\u4f55\u4e3a\u201c\u836f\u673a\u6cd5\u201d<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u836f\u673a\u6cd5\u662f\u4e00\u90e8\u5173\u4e8e\u533b\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u5fc5\u8981\u89c4\u5b9a\u7684\u6cd5\u5f8b\uff0c\u5176\u6b63\u5f0f\u540d\u79f0\u4e3a\u201c\u533b\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u7684\u8d28\u91cf\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u4fdd\u969c\u7b49\u76f8\u5173\u6cd5\u5f8b\u201d\u3002<\/p>\n\n\n\n<p>\u6b64\u6cd5\u5f8b\u66fe\u88ab\u79f0\u4e3a\u201c\u836f\u4e8b\u6cd5\u201d\uff0c\u4f46\u5728\u5e73\u621025\u5e74\uff082013\u5e74\uff09\u8fdb\u884c\u4e86\u4fee\u8ba2\uff08\u5e73\u621026\u5e74\u5b9e\u65bd\uff09\uff0c\u540d\u79f0\u4e5f\u88ab\u66f4\u6539\u4e3a\u201c\u836f\u673a\u6cd5\u201d\u3002\u6709\u65f6\u4e5f\u88ab\u79f0\u4e3a\u201c\u533b\u836f\u54c1\u533b\u7597\u5668\u68b0\u7b49\u6cd5\u201d\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%8D%AF%E6%9C%BA%E6%B3%95%E7%9A%84%E7%9B%AE%E7%9A%84\"><\/span>\u836f\u673a\u6cd5\u7684\u76ee\u7684<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u5173\u4e8e\u201c\u836f\u673a\u6cd5\u201d\u7684\u76ee\u7684\uff0c\u5728\u7b2c\u4e00\u6761\u4e2d\u89c4\u5b9a\u5982\u4e0b\uff1a<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u7b2c\u4e00\u6761\uff08\u76ee\u7684\uff09<\/p>\n\n\n\n<p>\u672c\u6cd5\u65e8\u5728\uff0c\u5bf9\u836f\u54c1\u3001\u533b\u836f\u90e8\u5916\u54c1\u3001\u5316\u5986\u54c1\u3001\u533b\u7597\u5668\u68b0\u4ee5\u53ca\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u836f\u54c1\u7b49\u201d\uff09\u7684\u8d28\u91cf\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u8fdb\u884c\u4fdd\u969c\uff0c\u5e76\u8fdb\u884c\u5fc5\u8981\u7684\u89c4\u5236\uff0c\u4ee5\u9632\u6b62\u548c\u6269\u5927\u8fd9\u4e9b\u4ea7\u54c1\u4f7f\u7528\u6240\u5e26\u6765\u7684\u516c\u5171\u536b\u751f\u5371\u5bb3\u3002\u6b64\u5916\uff0c\u8fd8\u5c06\u91c7\u53d6\u63aa\u65bd\u5bf9\u6307\u5b9a\u836f\u7269\u8fdb\u884c\u89c4\u5236\uff0c\u5e76\u91c7\u53d6\u5fc5\u8981\u7684\u63aa\u65bd\u4fc3\u8fdb\u5bf9\u533b\u7597\u4e0a\u7279\u522b\u9700\u8981\u7684\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u548c\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\u7684\u7814\u53d1\uff0c\u4ee5\u63d0\u9ad8\u516c\u5171\u536b\u751f\u6c34\u5e73\u3002<\/p>\n<cite>\u5173\u4e8e\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u7684\u8d28\u91cf\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u4fdd\u969c\u7b49\u6cd5\u5f8b \u7b2c\u4e00\u6761<\/cite><\/blockquote>\n\n\n\n<p>\u7b80\u5355\u6765\u8bf4\uff0c\u836f\u673a\u6cd5\u7684\u4e00\u4e2a\u76ee\u7684\u662f\u4e3a\u4e86\u4fdd\u969c\u836f\u54c1\u7b49\u7684\u8d28\u91cf\u3001\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0c\u5236\u5b9a\u5fc5\u8981\u7684\u89c4\u5b9a\u3002\u4e3a\u4e86\u5b9e\u73b0\u8fd9\u4e2a\u76ee\u7684\uff0c\u836f\u673a\u6cd5\u5bf9\u836f\u54c1\u7b49\u7684\u751f\u4ea7\u3001\u7ba1\u7406\u3001\u9500\u552e\u3001\u5e7f\u544a\u7b49\u5404\u4e2a\u9636\u6bb5\u90fd\u5236\u5b9a\u4e86\u5404\u79cd\u89c4\u5b9a\u3002<\/p>\n\n\n\n<p>\u76f8\u5173\u6587\u7ae0\uff1a<a href=\"https:\/\/monolith-law.jp\/?p=49834\" target=\"_blank\" rel=\"noreferrer noopener\">\u836f\u673a\u6cd5\uff08\u65e7\u836f\u4e8b\u6cd5\uff09\u662f\u4ec0\u4e48\uff1f\u76ee\u7684\u3001\u89c4\u5236\u5bf9\u8c61\u3001\u5e7f\u544a\u89c4\u5236\u89e3\u6790[ja]<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%9C%80%E8%A6%81%E6%B3%A8%E6%84%8F%E7%9A%84%E8%A7%84%E5%AE%9A%EF%BC%9A%E9%94%80%E5%94%AE%E5%92%8C%E5%B9%BF%E5%91%8A\"><\/span>\u9700\u8981\u6ce8\u610f\u7684\u89c4\u5b9a\uff1a\u9500\u552e\u548c\u5e7f\u544a<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u5728\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Japanese Pharmaceutical and Medical Device Act\uff09\u89c4\u5b9a\u7684\u5404\u9879\u89c4\u5b9a\u4e2d\uff0c\u7279\u522b\u9700\u8981\u6ce8\u610f\u7684\u662f\u9500\u552e\u89c4\u5b9a\u548c\u5e7f\u544a\u89c4\u5b9a\u3002<\/p>\n\n\n\n<p>\u5728\u56e0\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u800c\u5f15\u53d1\u7684\u5211\u4e8b\u6848\u4ef6\u4e2d\uff0c\u5927\u90e8\u5206\u90fd\u662f\u4e0e\u9500\u552e\u548c\u5e7f\u544a\u6709\u5173\u7684\u8fdd\u89c4\u884c\u4e3a\u3002<\/p>\n\n\n\n<p>\u6839\u636e\u65e5\u672c\u8b66\u5bdf\u5385\u7684\u72af\u7f6a\u7edf\u8ba1\u8d44\u6599\uff0c2020\u5e74\uff08\u4ee4\u548c2\u5e74\uff0c\u5373\u516c\u53862020\u5e74\uff09\u7684\u72af\u7f6a\u4e2d\uff0c\u56e0\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u800c\u88ab\u6355\u7684\u6848\u4ef6\u670963\u8d77\uff0c\u6bd4\u524d\u4e00\u5e74\u589e\u52a0\u4e8615\u8d77\u3002\u5176\u4e2d\uff0c\u4e0e\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u611f\u67d3\u75c7\u6709\u5173\u7684\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u670914\u8d77\u3002\uff08\u6765\u6e90\uff1a\u65e5\u672c\u8b66\u5bdf\u5385\u751f\u6d3b\u5b89\u5168\u5c40\u300c<a href=\"https:\/\/www.npa.go.jp\/publications\/statistics\/safetylife\/seikeikan\/R02_seikatsukeizaijihan.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u4ee4\u548c2\u5e74\u751f\u6d3b\u7ecf\u6d4e\u72af\u7f6a\u7684\u641c\u6355\u60c5\u51b5\u7b49[ja]<\/a>\u300d\uff09<\/p>\n\n\n\n<p>\u53e6\u5916\uff0c2021\u5e74\uff08\u4ee4\u548c3\u5e74\uff0c\u5373\u516c\u53862021\u5e74\uff09\u7684\u72af\u7f6a\u4e2d\uff0c\u56e0\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u800c\u88ab\u6355\u7684\u6848\u4ef6\u670946\u8d77\uff0c\u5176\u4e2d\u4e0e\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u611f\u67d3\u75c7\u6709\u5173\u7684\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u67097\u8d77\u3002\uff08\u6765\u6e90\uff1a\u65e5\u672c\u8b66\u5bdf\u5385\u751f\u6d3b\u5b89\u5168\u5c40\u300c<a href=\"https:\/\/www.npa.go.jp\/safetylife\/seikeikan\/R03_seikatsukeizaijihan.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u4ee4\u548c3\u5e74\u751f\u6d3b\u7ecf\u6d4e\u72af\u7f6a\u7684\u641c\u6355\u60c5\u51b5\u7b49[ja]<\/a>\u300d\uff09<\/p>\n\n\n\n<p>\u5173\u4e8e\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u7684\u5185\u5bb9\uff0c\u6839\u636e<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u7684\u7edf\u8ba1[ja]<\/a>\uff0c\u60c5\u51b5\u5982\u4e0b\uff1a<\/p>\n\n\n\n<p>2018\u5e74\uff08\u5e73\u621030\u5e74\uff0c\u5373\u516c\u53862018\u5e74\uff09\u5728\u4e1c\u4eac\u90fd\u53d1\u751f\u7684\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u670934\u8d77\uff0c\u5176\u4e2d15\u8d77\u4e0e\u9500\u552e\u6709\u5173\uff0c10\u8d77\u4e0e\u5e7f\u544a\u6709\u5173\u3002\uff08\u6765\u6e90\uff1a\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u300c<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/k_tokei30.html\" target=\"_blank\" rel=\"noreferrer noopener\">\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u7684\u7edf\u8ba1\uff08\u5e73\u621030\u5e74\uff09[ja]<\/a>\u300d\uff09<\/p>\n\n\n\n<p>2019\u5e74\uff08\u5e73\u621031\u5e74\/\u4ee4\u548c\u5143\u5e74\uff0c\u5373\u516c\u53862019\u5e74\uff09\u5728\u4e1c\u4eac\u90fd\u53d1\u751f\u7684\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u670912\u8d77\uff0c\u5176\u4e2d5\u8d77\u4e0e\u9500\u552e\u6709\u5173\uff0c1\u8d77\u4e0e\u5e7f\u544a\u6709\u5173\u3002\uff08\u6765\u6e90\uff1a\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u300c<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/k_tokei31.files\/ktd083.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u7684\u7edf\u8ba1\uff08\u5e73\u621031\u5e74\u30fb\u4ee4\u548c\u5143\u5e74\uff09[ja]<\/a>\u300d\uff09<\/p>\n\n\n\n<p>2020\u5e74\uff08\u4ee4\u548c2\u5e74\uff0c\u5373\u516c\u53862020\u5e74\uff09\u5728\u4e1c\u4eac\u90fd\u53d1\u751f\u7684\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4f8b\u670924\u8d77\uff0c\u5176\u4e2d12\u8d77\u4e0e\u9500\u552e\u6709\u5173\uff0c10\u8d77\u4e0e\u5e7f\u544a\u6709\u5173\u3002\uff08\u6765\u6e90\uff1a\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u300c<a href=\"https:\/\/www.keishicho.metro.tokyo.lg.jp\/about_mpd\/jokyo_tokei\/tokei\/k_tokei02.files\/ktd083.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u4e1c\u4eac\u90fd\u8b66\u89c6\u5385\u7684\u7edf\u8ba1\uff08\u4ee4\u548c2\u5e74\uff09[ja]<\/a>\u300d\uff09<\/p>\n\n\n\n<p>\u4ece\u8fd9\u4e9b\u7edf\u8ba1\u6570\u636e\u4e2d\uff0c\u6211\u4eec\u53ef\u4ee5\u770b\u51fa\uff0c\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u8fdd\u89c4\u6848\u4ef6\u7684\u5927\u90e8\u5206\u90fd\u662f\u4e0e\u9500\u552e\u548c\u5e7f\u544a\u6709\u5173\u7684\u89c4\u5b9a\u8fdd\u53cd\u3002\u56e0\u6b64\uff0c\u4e3a\u4e86\u907f\u514d\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff0c\u6b63\u786e\u7406\u89e3\u4e0e\u9500\u552e\u548c\u5e7f\u544a\u6709\u5173\u7684\u89c4\u5b9a\u5c24\u4e3a\u91cd\u8981\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%BF%9D%E5%8F%8D%E6%97%A5%E6%9C%AC%E3%80%8A%E8%8D%AF%E5%93%81%E3%80%81%E5%8C%BB%E7%96%97%E8%AE%BE%E5%A4%87%E7%AD%89%E7%9A%84%E8%B4%A8%E9%87%8F%E3%80%81%E6%95%88%E8%83%BD%E5%8F%8A%E5%AE%89%E5%85%A8%E6%80%A7%E6%B3%95%E3%80%8B%EF%BC%88Japanese_Pharmaceuticals_and_Medical_Devices_Act%EF%BC%89%E7%9A%84%E8%A1%8C%E4%B8%BA\"><\/span>\u8fdd\u53cd\u65e5\u672c\u300a\u836f\u54c1\u3001\u533b\u7597\u8bbe\u5907\u7b49\u7684\u8d28\u91cf\u3001\u6548\u80fd\u53ca\u5b89\u5168\u6027\u6cd5\u300b\uff08Japanese Pharmaceuticals and Medical Devices Act\uff09\u7684\u884c\u4e3a<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u5728\u6b64\uff0c\u6211\u4eec\u5c06\u5728\u89e3\u91ca\u7f5a\u5219\u548c\u902e\u6355\u6761\u4ef6\u7684\u524d\u63d0\u4e0b\uff0c\u5bf9\u65e5\u672c\u300a\u836f\u54c1\u3001\u533b\u7597\u8bbe\u5907\u7b49\u7684\u8d28\u91cf\u3001\u6548\u80fd\u53ca\u5b89\u5168\u6027\u6cd5\u300b\u6240\u89c4\u5b9a\u7684\u89c4\u5b9a\u8fdb\u884c\u89e3\u91ca\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%A7%84%E5%88%B6%E5%AF%B9%E8%B1%A1\"><\/span>\u89c4\u5236\u5bf9\u8c61<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u300a\u65e5\u672c\u836f\u68b0\u6cd5\u300b\uff08Japanese Pharmaceutical and Medical Device Act\uff09\u7684\u4e3b\u8981\u89c4\u5236\u5bf9\u8c61\u5982\u7b2c1\u6761\u6240\u8ff0\uff0c\u5305\u62ec\u836f\u54c1\u3001\u836f\u7528\u90e8\u5916\u54c1\u3001\u5316\u5986\u54c1\u3001\u533b\u7597\u5668\u68b0\u3001\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\u8fd9\u4e94\u7c7b\uff08\u836f\u54c1\u7b49\uff09\u3002<\/p>\n\n\n\n<p>\u6240\u8c13\u201c\u836f\u54c1\u201d\uff0c\u7b80\u5355\u6765\u8bf4\uff0c\u662f\u7528\u4e8e\u75be\u75c5\u6216\u4f24\u53e3\u7684\u8bca\u65ad\u3001\u6cbb\u7597\u3001\u9884\u9632\uff0c\u6216\u8005\u5f71\u54cd\u4eba\u4f53\u6216\u529f\u80fd\u7684\u7269\u54c1\uff08\u7b2c2\u6761\u7b2c1\u6b3e\uff09\u3002\u5177\u4f53\u4f8b\u5b50\u5305\u62ec\u6297\u539f\u7279\u5f02\u6027\u68c0\u6d4b\u8bd5\u5242\u76d2\u548c\u907f\u5b55\u836f\u7b49\u3002<\/p>\n\n\n\n<p>\u6240\u8c13\u201c\u836f\u7528\u90e8\u5916\u54c1\u201d\uff0c\u7b80\u5355\u6765\u8bf4\uff0c\u867d\u7136\u5bf9\u4eba\u4f53\u6709\u5f71\u54cd\uff0c\u4f46\u76f8\u6bd4\u836f\u54c1\uff0c\u5176\u5f71\u54cd\u8f83\u4e3a\u6e29\u548c\uff08\u7b2c2\u6761\u7b2c2\u6b3e\uff09\u3002\u5177\u4f53\u4f8b\u5b50\u5305\u62ec\u53e3\u81ed\u55b7\u96fe\u3001\u6740\u866b\u5242\u3001\u9690\u5f62\u773c\u955c\u6e05\u6d01\u6db2\u7b49\u3002<\/p>\n\n\n\n<p>\u6240\u8c13\u201c\u5316\u5986\u54c1\u201d\uff0c\u7b80\u5355\u6765\u8bf4\uff0c\u76f8\u6bd4\u836f\u7528\u90e8\u5916\u54c1\uff0c\u5bf9\u4eba\u4f53\u7684\u5f71\u54cd\u66f4\u4e3a\u6e29\u548c\uff0c\u7528\u4e8e\u6e05\u6d01\u4eba\u4f53\uff0c\u4fdd\u6301\u76ae\u80a4\u548c\u5934\u53d1\u5065\u5eb7\uff0c\u6216\u8005\u6d82\u62b9\u5728\u8eab\u4f53\u4e0a\u7684\u7269\u54c1\uff08\u7b2c2\u6761\u7b2c3\u6b3e\uff09\u3002\u5177\u4f53\u4f8b\u5b50\u5305\u62ec\u4e00\u822c\u5316\u5986\u54c1\u3001\u6d17\u53d1\u6c34\u3001\u7259\u818f\u3001\u62a4\u80a4\u54c1\u548c\u8eab\u4f53\u4e73\u7b49\u3002<\/p>\n\n\n\n<p>\u6240\u8c13\u201c\u533b\u7597\u5668\u68b0\u201d\uff0c\u7b80\u5355\u6765\u8bf4\uff0c\u662f\u5f71\u54cd\u8eab\u4f53\u7ed3\u6784\u6216\u529f\u80fd\uff0c\u6216\u8005\u7528\u4e8e\u8bca\u65ad\u3001\u6cbb\u7597\u3001\u9884\u9632\u7684\u673a\u68b0\u8bbe\u5907\u7b49\uff08\u7b2c2\u6761\u7b2c4\u6b3e\uff09\u3002\u5177\u4f53\u4f8b\u5b50\u5305\u62ec\u4f53\u6e29\u8ba1\u3001\u7f1d\u5408\u7ebf\u3001\u907f\u5b55\u7528\u5177\u3001\u75be\u75c5\u8bca\u65ad\u7a0b\u5e8f\u7b49\u3002<\/p>\n\n\n\n<p>\u6240\u8c13\u201c\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\u201d\uff0c\u662f\u6307\u5bf9\u7ec6\u80de\u8fdb\u884c\u57f9\u517b\u7b49\u52a0\u5de5\uff0c\u6216\u8005\u4e3a\u4e86\u6cbb\u7597\u76ee\u7684\u5f15\u5165\u7ec6\u80de\uff0c\u5e76\u5728\u4f53\u5185\u8868\u8fbe\u7684\u542b\u6709\u57fa\u56e0\u7684\u7269\u54c1\uff08\u7b2c2\u6761\u7b2c9\u6b3e\uff09\u3002\u5177\u4f53\u4f8b\u5b50\u5305\u62ec\u7528\u4e8e\u79fb\u690d\u7684\u521b\u4f24\u6027\u8f6f\u9aa8\u7f3a\u635f\u75c7\u7684\u8f6f\u9aa8\u7ec4\u7ec7\u7b49\u3002<\/p>\n\n\n\n<p>\u300a\u65e5\u672c\u836f\u68b0\u6cd5\u300b\u4e3b\u8981\u9488\u5bf9\u4e0a\u8ff0\u4e94\u7c7b\u4ea7\u54c1\u8fdb\u884c\u89c4\u5236\uff0c\u5e76\u5bf9\u9500\u552e\u548c\u5e7f\u544a\u8bbe\u5b9a\u4e86\u9650\u5236\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%8D%AF%E5%93%81%E6%9C%BA%E6%A2%B0%E6%B3%95%E7%9A%84%E9%94%80%E5%94%AE%E8%A7%84%E5%AE%9A\"><\/span>\u836f\u54c1\u673a\u68b0\u6cd5\u7684\u9500\u552e\u89c4\u5b9a<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u836f\u54c1\u673a\u68b0\u6cd5\u5bf9\u836f\u54c1\u7b49\u8fdb\u884c\u4e86\u9500\u552e\u76f8\u5173\u7684\u89c4\u5b9a\u3002<\/p>\n\n\n\n<p>\u5bf9\u4e8e\u836f\u54c1\u3001\u9ad8\u7ea7\u7ba1\u7406\u533b\u7597\u5668\u68b0\u3001\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\uff0c\u5982\u679c\u6ca1\u6709\u536b\u751f\u52b3\u52a8\u5927\u81e3\u7684\u8bb8\u53ef\uff0c\u5c31\u4e0d\u5141\u8bb8\u8fdb\u884c\u9500\u552e\u4e1a\u52a1\uff08\u7b2c24\u6761\uff09\u3002\u53e6\u5916\uff0c\u5bf9\u4e8e\u7ba1\u7406\u533b\u7597\u5668\u68b0\uff0c\u9700\u8981\u62a5\u544a\u9500\u552e\u60c5\u51b5\uff08\u7b2c29\u6761\u76843\uff09\u3002<\/p>\n\n\n\n<p>\u8fd9\u4e9b\u89c4\u5b9a\u9002\u7528\u4e8e&#8221;\u4f5c\u4e3a\u4e1a\u52a1&#8221;\u8fdb\u884c\u9500\u552e\u7684\u60c5\u51b5\u3002&#8221;\u4f5c\u4e3a\u4e1a\u52a1&#8221;\u662f\u6307\u53ef\u4ee5\u8bc4\u4f30\u4e3a\u4e1a\u52a1\u6267\u884c\u7684\u91cd\u590d\u6027\u548c\u6301\u7eed\u6027\u7684\u67d0\u79cd\u884c\u4e3a\u3002\u6279\u53d1\u4e1a\u6216\u96f6\u552e\u4e1a\u5f53\u7136\u5305\u62ec\u5728\u5185\uff0c\u4e2a\u4eba\u7684\u8f6c\u552e\u4e5f\u53ef\u80fd\u9002\u7528\uff0c\u9700\u8981\u6ce8\u610f\u3002<\/p>\n\n\n\n<p>\u53e6\u5916\uff0c\u9500\u552e\u672a\u7ecf\u6279\u51c6\u6216\u8bb8\u53ef\u7684\u836f\u54c1\u7b49\uff08\u65e0\u6279\u51c6\u65e0\u8bb8\u53ef\u836f\u54c1\uff09\u4e5f\u662f\u88ab\u7981\u6b62\u7684\uff08\u7b2c55\u67612\u6b3e\u3001\u7b2c60\u6761\u3001\u7b2c62\u6761\u3001\u7b2c64\u6761\u3001\u7b2c65\u6761\u76844\uff09\u3002\u7279\u522b\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u5373\u4f7f\u662f\u4f5c\u4e3a\u98df\u54c1\u7b49\u9500\u552e\u7684\u4ea7\u54c1\uff0c\u5982\u679c\u88ab\u5224\u65ad\u4e3a&#8221;\u836f\u54c1&#8221;\uff0c\u90a3\u4e48\u4f5c\u4e3a\u65e0\u6279\u51c6\u65e0\u8bb8\u53ef\u836f\u54c1\u7684\u9500\u552e\u5c31\u4f1a\u53d8\u5f97\u975e\u6cd5\u3002<\/p>\n\n\n\n<p>\u5173\u4e8e&#8221;\u836f\u54c1&#8221;\u7684\u9002\u7528\u6027\uff0c\u6839\u636e\u5224\u4f8b\uff0c\u5c06\u6839\u636e\u4ee5\u4e0b\u6807\u51c6\u8fdb\u884c\u5224\u65ad\uff1a<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u7efc\u5408\u8003\u8651\u7269\u54c1\u7684\u6210\u5206\u3001\u5f62\u72b6\u3001\u540d\u79f0\u3001\u7269\u54c1\u4e0a\u663e\u793a\u7684\u4f7f\u7528\u76ee\u7684\u30fb\u529f\u6548\u6548\u679c\u30fb\u7528\u6cd5\u7528\u91cf\u3001\u9500\u552e\u65b9\u5f0f\u3001\u9500\u552e\u65f6\u7684\u9648\u8ff0\u30fb\u5ba3\u4f20\u7b49\uff0c\u901a\u5e38\u4eba\u7406\u89e3\u4e3a&#8221;\u7528\u4e8e\u4eba\u6216\u52a8\u7269\u7684\u75be\u75c5\u7684\u8bca\u65ad\u3001\u6cbb\u7597\u6216\u9884\u9632&#8221;\u7684\u7269\u54c1\uff0c\u4e0d\u8bba\u5176\u662f\u5426\u5177\u6709\u5ba2\u89c2\u7684\u836f\u7406\u4f5c\u7528\u3002<\/p>\n<cite>\u6700\u9ad8\u6cd5\u9662\u662d\u548c57\u5e74\uff081982\u5e74\uff099\u670828\u65e5\u5211\u4e8b\u96c636\u53778\u53f7787\u9875<\/cite><\/blockquote>\n\n\n\n<p>\u5373\u4f7f\u662f\u4f5c\u4e3a\u98df\u54c1\u9500\u552e\u7684\u4ea7\u54c1\uff0c\u4e5f\u9700\u8981\u7efc\u5408\u8003\u8651\u5f62\u72b6\u3001\u529f\u6548\u6548\u679c\u3001\u9500\u552e\u65b9\u5f0f\u548c\u5e7f\u544a\u7b49\uff0c\u6765\u5224\u65ad\u662f\u5426\u5c5e\u4e8e&#8221;\u836f\u54c1&#8221;\u3002<\/p>\n\n\n\n<p>\u53e6\u5916\uff0c\u6839\u636e\u536b\u751f\u52b3\u52a8\u7701\u7684&#8221;<a href=\"https:\/\/www.mhlw.go.jp\/content\/000658257.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u836f\u54c1\u8303\u56f4\u7684\u6807\u51c6\u90e8\u5206\u4fee\u8ba2\uff08\u4ee4\u548c2\u5e74\uff082020\u5e74\uff093\u670831\u65e5\u836f\u751f\u53d10331\u7b2c33\u53f7\uff09[ja]<\/a>&#8220;\uff0c\u5982\u679c\u6807\u699c\u836f\u54c1\u7684\u529f\u6548\u6548\u679c\uff0c\u5c06\u88ab\u89c6\u4e3a&#8221;\u836f\u54c1&#8221;\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u6839\u636e\u9500\u552e\u65b9\u5f0f\u548c\u5e7f\u544a\u5185\u5bb9\uff0c\u53ef\u80fd\u4f1a\u88ab\u89c6\u4e3a&#8221;\u836f\u54c1&#8221;\uff0c\u9500\u552e\u53ef\u80fd\u4f1a\u53d8\u5f97\u975e\u6cd5\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%8D%AF%E6%9C%BA%E6%B3%95%E7%9A%84%E5%B9%BF%E5%91%8A%E8%A7%84%E5%AE%9A\"><\/span>\u836f\u673a\u6cd5\u7684\u5e7f\u544a\u89c4\u5b9a<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u836f\u673a\u6cd5\uff08\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\uff09\u5728\u7b2c66\u6761\u81f3\u7b2c68\u6761\u4e2d\u8bbe\u5b9a\u4e86\u5173\u4e8e\u5e7f\u544a\u7684\u89c4\u5b9a\u3002\u5728\u8fd9\u5176\u4e2d\uff0c\u6211\u4eec\u5c06\u7279\u522b\u89e3\u91ca\u7b2c66\u6761\u548c\u7b2c68\u6761\u7684\u91cd\u8981\u89c4\u5b9a\u3002<\/p>\n\n\n\n<blockquote class=\"wp-block-quote\">\n<p>\u7b2c66\u6761\uff08\u5938\u5927\u5e7f\u544a\u7b49\uff09<\/p>\n\n\n\n<p>\u4efb\u4f55\u4eba\u4e0d\u5f97\u5bf9\u836f\u54c1\u3001\u975e\u836f\u7528\u54c1\u3001\u5316\u5986\u54c1\u3001\u533b\u7597\u5668\u68b0\u6216\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\u7684\u540d\u79f0\u3001\u5236\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u8fdb\u884c\u865a\u5047\u6216\u5938\u5927\u7684\u5e7f\u544a\u3001\u63cf\u8ff0\u6216\u4f20\u64ad\uff0c\u65e0\u8bba\u662f\u660e\u793a\u8fd8\u662f\u6697\u793a\u3002<\/p>\n\n\n\n<p>2 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class=\"wp-block-quote\">\n<p>\u7b2c68\u6761\uff08\u672a\u7ecf\u6279\u51c6\u7684\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u53ca\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\u7684\u5e7f\u544a\u7981\u6b62\uff09<\/p>\n\n\n\n<p>\u4efb\u4f55\u4eba\uff0c\u5bf9\u4e8e\u7b2c\u5341\u56db\u6761\u7b2c\u4e00\u6b3e\u3001\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e8c\u4e4b\u4e94\u7b2c\u4e00\u6b3e\u6216\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e8c\u4e4b\u4e8c\u5341\u4e09\u7b2c\u4e00\u6b3e\u6240\u89c4\u5b9a\u7684\u836f\u54c1\u6216\u533b\u7597\u5668\u68b0\u6216\u518d\u751f\u533b\u7597\u7b49\u4ea7\u54c1\uff0c\u5c1a\u672a\u63a5\u53d7\u7b2c\u5341\u56db\u6761\u7b2c\u4e00\u6b3e\u3001\u7b2c\u5341\u4e5d\u6761\u4e4b\u4e8c\u7b2c\u4e00\u6b3e\u3001\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e8c\u4e4b\u4e94\u7b2c\u4e00\u6b3e\u3001\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e8c\u4e4b\u5341\u4e03\u7b2c\u4e00\u6b3e\u3001\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e8c\u5341\u4e94\u7b2c\u4e00\u6b3e\u6216\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e09\u5341\u4e03\u7b2c\u4e00\u6b3e\u7684\u6279\u51c6\u6216\u7b2c\u4e8c\u5341\u4e09\u6761\u4e4b\u4e8c\u4e4b\u4e8c\u5341\u4e09\u7b2c\u4e00\u6b3e\u7684\u8ba4\u8bc1\uff0c\u4e0d\u5f97\u5bf9\u5176\u540d\u79f0\u3001\u5236\u9020\u65b9\u6cd5\u3001\u529f\u6548\u3001\u6548\u679c\u6216\u6027\u80fd\u8fdb\u884c\u5e7f\u544a\u3002<\/p>\n<cite>\u65e5\u672c\u300a\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u7684\u8d28\u91cf\u3001\u6709\u6548\u6027\u53ca\u5b89\u5168\u6027\u7684\u4fdd\u969c\u7b49\u6cd5\u300b\u7b2c\u516d\u5341\u516b\u6761<\/cite><\/blockquote>\n\n\n\n<p>\u5c06\u7b2c66\u6761\u548c\u7b2c68\u6761\u7684\u89c4\u5b9a\u603b\u7ed3\u8d77\u6765\uff0c\u4ee5\u4e0b\u7684\u5e7f\u544a\u662f\u88ab\u7981\u6b62\u7684\uff1a<\/p>\n\n\n\n<ol>\n<li>\u865a\u5047\u6216\u5938\u5927\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u8bef\u5bfc\u6d88\u8d39\u8005\u8ba4\u4e3a\u533b\u751f\u7b49\u4fdd\u8bc1\u4e86\u836f\u54c1\u6548\u679c\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u4f7f\u7528\u6697\u793a\u5815\u80ce\u6216\u6deb\u79fd\u6587\u5b57\u3001\u56fe\u753b\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u672a\u7ecf\u6279\u51c6\u7684\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u7684\u5e7f\u544a<\/li>\n<\/ol>\n\n\n\n<p>\u5173\u4e8e\u65e5\u672c\u300a\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u6cd5\u300b\u4e2d\u201c\u5e7f\u544a\u201d\u7684\u5b9a\u4e49\uff0c\u5df2\u4e8e1998\u5e74\uff08\u5e73\u621010\u5e74\uff099\u670829\u65e5\u7531\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u533b\u836f\u5b89\u5168\u5c40\u76d1\u89c6\u6307\u5bfc\u79d1\u957f\u901a\u77e5\u516c\u5e03\uff08<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_d.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u836f\u54c1\u7b49\u5e7f\u544a\u7684\u9002\u7528\u6027[ja]<\/a>\uff09\u3002\u6839\u636e\u6b64\u901a\u77e5\uff0c\u6ee1\u8db3\u4ee5\u4e0b\u4e09\u4e2a\u8981\u4ef6\u7684\u60c5\u51b5\u5c06\u88ab\u5224\u65ad\u4e3a\u201c\u5e7f\u544a\u201d\uff1a<\/p>\n\n\n\n<ul>\n<li>\u660e\u786e\u6709\u5438\u5f15\u5ba2\u6237\uff08\u63d0\u9ad8\u8d2d\u4e70\u6b32\u671b\uff09\u7684\u610f\u56fe\uff08\u8bf1\u56e0\u6027\uff09<\/li>\n\n\n\n<li>\u660e\u786e\u663e\u793a\u4e86\u7279\u5b9a\u836f\u54c1\u7b49\u7684\u5546\u54c1\u540d\uff08\u7279\u5b9a\u6027\uff09<\/li>\n\n\n\n<li>\u4e00\u822c\u4eba\u80fd\u591f\u8ba4\u77e5\u7684\u72b6\u6001\uff08\u8ba4\u77e5\u6027\uff09<\/li>\n<\/ul>\n\n\n\n<p>\u7b2c66\u6761\u548c\u7b2c68\u6761\u7684\u5e7f\u544a\u89c4\u5b9a\uff0c\u5982\u201c\u4efb\u4f55\u4eba\u201d\u6240\u793a\uff0c\u9002\u7528\u4e8e\u6240\u6709\u4eba\uff0c\u6ca1\u6709\u9650\u5b9a\u89c4\u5b9a\u5bf9\u8c61\u3002\u4e0d\u4ec5\u533b\u7597\u76f8\u5173\u4eba\u5458\u548c\u5e7f\u544a\u8bf7\u6c42\u8005\uff0c\u5e7f\u544a\u4ee3\u7406\u5546\u3001\u8054\u76df\u4f1a\u5458\u3001\u5f71\u54cd\u8005\u7b49\u4e5f\u662f\u89c4\u5b9a\u5bf9\u8c61\uff0c\u4e0d\u8bba\u662f\u6cd5\u4eba\u8fd8\u662f\u4e2a\u4eba\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u5bf9\u5e7f\u544a\u5a92\u4ecb\u6ca1\u6709\u9650\u5b9a\uff0c\u56e0\u6b64\uff0c\u4e0d\u4ec5\u662f\u4f20\u5355\u3001\u6742\u5fd7\u7b49\u7eb8\u8d28\u5a92\u4ecb\u548c\u7f51\u7ad9\uff0c\u4e2a\u4eba\u7684\u793e\u4ea4\u5a92\u4f53\u4e5f\u662f\u89c4\u5b9a\u5bf9\u8c61\u3002<\/p>\n\n\n\n<p>\u76f8\u5173\u6587\u7ae0\uff1a<a href=\"https:\/\/monolith-law.jp\/?p=49842\" target=\"_blank\" rel=\"noreferrer noopener\">\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u6cd5\u7684\u5e7f\u544a\u89c4\u5b9a\u662f\u4ec0\u4e48\uff1f\u89e3\u91ca\u5982\u4f55\u5408\u6cd5\u8868\u8fbe\u4ee5\u521b\u5efa\u5e7f\u544a[ja]<\/a><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E8%BF%9D%E5%8F%8D%E5%B9%BF%E5%91%8A%E7%9A%84%E5%88%A4%E6%96%AD%E6%A0%87%E5%87%86\"><\/span>\u8fdd\u53cd\u5e7f\u544a\u7684\u5224\u65ad\u6807\u51c6<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u662f\u5426\u8fdd\u53cd\u65e5\u672c\u300a\u836f\u68b0\u6cd5\u300b\u7684\u5e7f\u544a\u89c4\u5b9a\uff0c\u662f\u6839\u636e\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u7684\u901a\u77e5\uff0c\u5373\u300c<a href=\"https:\/\/www.mhlw.go.jp\/bunya\/iyakuhin\/koukokukisei\/dl\/index_c.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u533b\u836f\u54c1\u7b49\u9002\u5f53\u5e7f\u544a\u6807\u51c6[ja]<\/a>\u300d\u548c\u300c<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/0000179263.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u533b\u836f\u54c1\u7b49\u9002\u5f53\u5e7f\u544a\u6807\u51c6\u7684\u89e3\u91ca\u53ca\u6ce8\u610f\u4e8b\u9879\u7b49[ja]<\/a>\u300d\u6765\u5224\u65ad\u7684\u3002<\/p>\n\n\n\n<p>\u5728\u533b\u836f\u54c1\u7b49\u9002\u5f53\u5e7f\u544a\u6807\u51c6\u4e2d\uff0c\u5217\u51fa\u4e86\u4ee5\u4e0b14\u4e2a\u6807\u51c6\uff1a<\/p>\n\n\n\n<ol>\n<li>\u540d\u79f0\u76f8\u5173<\/li>\n\n\n\n<li>\u5236\u9020\u65b9\u6cd5\u76f8\u5173<\/li>\n\n\n\n<li>\u529f\u6548\u6548\u679c\u3001\u6027\u80fd\u53ca\u5b89\u5168\u6027\u76f8\u5173<\/li>\n\n\n\n<li>\u9650\u5236\u53ef\u80fd\u4fc3\u8fdb\u8fc7\u91cf\u6d88\u8d39\u6216\u6ee5\u7528\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u9650\u5236\u533b\u7597\u7528\u836f\u54c1\u7b49\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u9650\u5236\u4e00\u822c\u5411\u5e7f\u544a\u4e2d\u5173\u4e8e\u529f\u6548\u6548\u679c\u7684\u8868\u8ff0<\/li>\n\n\n\n<li>\u5e94\u5728\u4e60\u60ef\u6027\u836f\u54c1\u7684\u5e7f\u544a\u4e2d\u6ce8\u660e\u6216\u9644\u8a00\u7684\u4e8b\u9879<\/li>\n\n\n\n<li>\u5e94\u5728\u836f\u54c1\u7b49\u7684\u5e7f\u544a\u4e2d\u5173\u4e8e\u4f7f\u7528\u53ca\u5904\u7406\u6ce8\u610f\u4e8b\u9879\u7684\u6ce8\u660e\u6216\u9644\u8a00<\/li>\n\n\n\n<li>\u9650\u5236\u8bfd\u8c24\u4ed6\u516c\u53f8\u4ea7\u54c1\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u533b\u836f\u76f8\u5173\u4eba\u5458\u7684\u63a8\u8350<\/li>\n\n\n\n<li>\u9650\u5236\u5956\u8d4f\u3001\u5956\u54c1\u7b49\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u9650\u5236\u53ef\u80fd\u5f15\u53d1\u4e0d\u5feb\u3001\u56f0\u6270\u3001\u4e0d\u5b89\u6216\u6050\u60e7\u7684\u5e7f\u544a<\/li>\n\n\n\n<li>\u7535\u89c6\u3001\u5e7f\u64ad\u8282\u76ee\u4e2d\u7684\u5e7f\u544a\u5904\u7406<\/li>\n\n\n\n<li>\u9650\u5236\u5173\u4e8e\u836f\u54c1\u7684\u5316\u5986\u54c1\u6216\u98df\u54c1\u7528\u6cd5\uff0c\u6216\u533b\u7597\u5668\u68b0\u7684\u7f8e\u5bb9\u5668\u5177\u6216\u5065\u5eb7\u5668\u5177\u7528\u6cd5\u7684\u8868\u8ff0<\/li>\n<\/ol>\n\n\n\n<p>\u5e7f\u544a\u8868\u8ff0\u662f\u5426\u8fdd\u53cd\u836f\u68b0\u6cd5\uff0c\u5c06\u6839\u636e\u4e0a\u8ff0\u6807\u51c6\u8fdb\u884c\u5224\u65ad\u3002\u4f8b\u5982\uff0c\u5bf9\u4e8e\u7b2c3\u9879\u529f\u6548\u6548\u679c\uff0c\u89c4\u5b9a\u4e86\u201c\u9700\u8981\u6279\u51c6\u7684\u836f\u54c1\u7b49\u7684\u529f\u6548\u6548\u679c\u6216\u6027\u80fd\u7684\u8868\u8ff0\uff0c\u5e94\u4e0d\u8d85\u8fc7\u83b7\u5f97\u6279\u51c6\u7684\u529f\u6548\u6548\u679c\u7b49\u7684\u8303\u56f4\u201d\uff0c\u8d85\u51fa\u8bb8\u53ef\u8303\u56f4\u7684\u5e7f\u544a\u8868\u8ff0\u5c06\u88ab\u89c6\u4e3a\u8fdd\u53cd\u836f\u68b0\u6cd5\u3002<\/p>\n\n\n\n<h4 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%92%8C%E5%8C%BB%E7%96%97%E8%AE%BE%E5%A4%87%E6%B3%95%E3%80%8B%E7%9A%84%E5%B9%BF%E5%91%8A%E7%A4%BA%E4%BE%8B\"><\/span>\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u8bbe\u5907\u6cd5\u300b\u7684\u5e7f\u544a\u793a\u4f8b<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u90a3\u4e48\uff0c\u5177\u4f53\u6765\u8bf4\uff0c\u4ec0\u4e48\u6837\u7684\u5e7f\u544a\u8868\u8fbe\u65b9\u5f0f\u4f1a\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u8bbe\u5907\u6cd5\u300b\u5462\uff1f\u8ba9\u6211\u4eec\u7279\u522b\u5173\u6ce8\u5316\u5986\u54c1\u548c\u98df\u54c1\uff0c\u786e\u8ba4\u4e00\u4e9b\u53ef\u80fd\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u8bbe\u5907\u6cd5\u300b\u7684\u5e7f\u544a\u793a\u4f8b\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%A1%88%E4%BE%8B1%EF%BC%9A%E5%8C%96%E5%A6%86%E5%93%81\"><\/span>\u6848\u4f8b1\uff1a\u5316\u5986\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5173\u4e8e\u5316\u5986\u54c1\u7684\u5e7f\u544a\uff0c\u9664\u4e86\u300c\u65e5\u672c\u533b\u836f\u54c1\u7b49\u9002\u5f53\u5e7f\u544a\u6807\u51c6\u300d\u4e4b\u5916\uff0c\u8fd8\u6709\u300c<a href=\"https:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-11120000-Iyakushokuhinkyoku\/kesyouhin_hanni_20111.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u5173\u4e8e\u5316\u5986\u54c1\u529f\u6548\u8303\u56f4\u7684\u4fee\u8ba2[ja]<\/a>\u300d\u4e5f\u63d0\u4f9b\u4e86\u5224\u65ad\u662f\u5426\u8fdd\u53cd\u836f\u68b0\u6cd5\u7684\u6807\u51c6\u3002<\/p>\n\n\n\n<p>\u5728\u8fd9\u91cc\uff0c\u89c4\u5b9a\u4e86\u5173\u4e8e\u5316\u5986\u54c1\u768456\u79cd\u529f\u6548\u8868\u73b0\u7684\u8303\u56f4\uff0c\u8d85\u51fa\u8fd9\u4e2a\u8303\u56f4\u7684\u8868\u8ff0\u5c06\u4f1a\u8fdd\u53cd\u836f\u68b0\u6cd5\u3002<\/p>\n\n\n\n<p>\u5177\u4f53\u6765\u8bf4\uff0c\u4ee5\u4e0b\u8fd9\u4e9b\u8868\u8ff0\u8d85\u51fa\u4e86\u5316\u5986\u54c1\u88ab\u5141\u8bb8\u7684\u529f\u6548\u8303\u56f4\uff0c\u5c06\u4f1a\u8fdd\u53cd\u836f\u68b0\u6cd5\uff1a<\/p>\n\n\n\n<ul>\n<li>\u300c\u5982\u679c\u60f3\u8981\u6d88\u9664\u76ae\u80a4\u75b2\u52b3\u300d<\/li>\n\n\n\n<li>\u300c\u80fd\u591f\u6df1\u5165\u76ae\u80a4\u5185\u90e8\u300d<\/li>\n\n\n\n<li>\u300c\u9884\u9632\u76b1\u7eb9\u300d<\/li>\n\n\n\n<li>\u300c\u6cbb\u7597\u25cb\u25cb\u300d<\/li>\n\n\n\n<li>\u300c\u518d\u751f\u25cb\u25cb\u300d<\/li>\n\n\n\n<li>\u300c\u6e90\u4e8e\u7ec6\u80de\u7684\u529b\u91cf\u300d<\/li>\n\n\n\n<li>\u300c\u6700\u597d\u7684\u6392\u6bd2\u300d<\/li>\n\n\n\n<li>\u300c\u4f7f\u5934\u53d1\u518d\u751f\u5e76\u4ece\u672c\u8d28\u4e0a\u6539\u5584\u300d<\/li>\n\n\n\n<li>\u300c\u901a\u8fc7\u6297\u8870\u8001\u62a4\u7406\u53d8\u5e74\u8f7b\u300d<\/li>\n\n\n\n<li>\u300c\u6539\u5584\u80a4\u8d28\u7684\u6297\u8870\u8001\u62a4\u7406\u300d<\/li>\n\n\n\n<li>\u300c\u81ea\u4ece\u6211\u7528\u4e86\u8fd9\u4e2a\uff0c\u6211\u5c31\u6ca1\u6709\u518d\u957f\u51fa\u7ec6\u7eb9\uff01\u300d<\/li>\n\n\n\n<li>\u300c\u6700\u597d\u7684\u5316\u5986\u54c1\u300d<\/li>\n\n\n\n<li>\u300c\u5feb\u901f\u89c1\u6548\u300d<\/li>\n\n\n\n<li>\u300c\u7edd\u5bf9\u4fdd\u8bc1\u300d<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%A1%88%E4%BE%8B2%EF%BC%9A%E9%A3%9F%E5%93%81\"><\/span>\u6848\u4f8b2\uff1a\u98df\u54c1<span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>\u5728\u65e5\u672c\u7684\u300a\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u7684\u54c1\u8d28\u3001\u6548\u80fd\u53ca\u5b89\u5168\u6027\u7684\u4fdd\u969c\u7b49\u5173\u4e8e\u836f\u54c1\u53ca\u533b\u7597\u5668\u68b0\u7684\u6cd5\u5f8b\u300b\uff08\u85ac\u6a5f\u6cd5\uff09\u4e2d\uff0c\u5e76\u6ca1\u6709\u5173\u4e8e\u98df\u54c1\u7684\u89c4\u5b9a\u3002\u56e0\u6b64\uff0c\u6709\u4e9b\u4eba\u53ef\u80fd\u4f1a\u8ba4\u4e3a\uff0c\u65e0\u8bba\u5bf9\u98df\u54c1\u8fdb\u884c\u4f55\u79cd\u5e7f\u544a\uff0c\u90fd\u4e0d\u4f1a\u8fdd\u53cd\u85ac\u6a5f\u6cd5\u3002<\/p>\n\n\n\n<p>\u7136\u800c\uff0c\u5373\u4f7f\u662f\u98df\u54c1\uff0c\u5982\u679c\u5176\u6807\u7b7e\u6216\u5e7f\u544a\u5185\u5bb9\u5ba3\u79f0\u5177\u6709\u7c7b\u4f3c\u836f\u54c1\u7684\u529f\u6548\uff0c\u90a3\u4e48\u5b83\u5c06\u88ab\u89c6\u4e3a\u836f\u54c1\u3002<\/p>\n\n\n\n<p>\u4e00\u65e6\u88ab\u89c6\u4e3a\u836f\u54c1\uff0c\u5982\u679c\u6ca1\u6709\u4f5c\u4e3a\u836f\u54c1\u7684\u6279\u51c6\uff0c\u6839\u636e\u7b2c68\u6761\uff0c\u5e7f\u544a\u5c06\u88ab\u89c6\u4e3a\u8fdd\u53cd\u85ac\u6a5f\u6cd5\u3002<\/p>\n\n\n\n<p>\u4e5f\u5c31\u662f\u8bf4\uff0c\u5373\u4f7f\u662f\u672c\u6765\u4e0d\u53d7\u85ac\u6a5f\u6cd5\u7ba1\u5236\u7684\u4ea7\u54c1\uff0c\u5982\u679c\u8fdb\u884c\u5ba3\u79f0\u5177\u6709\u7c7b\u4f3c\u836f\u54c1\u7684\u529f\u6548\u7684\u5e7f\u544a\uff0c\u4e5f\u4f1a\u88ab\u89c6\u4e3a\u8fdd\u53cd\u85ac\u6a5f\u6cd5\u3002<\/p>\n\n\n\n<p>\u7136\u800c\uff0c\u6839\u636e\u201c\u5065\u5eb7\u529f\u80fd\u98df\u54c1\u5236\u5ea6\u201d\uff0c\u5bf9\u4e8e\u90e8\u5206\u98df\u54c1\uff0c\u56fd\u5bb6\u5141\u8bb8\u663e\u793a\u5176\u8ba4\u53ef\u7684\u529f\u80fd\u3002&#8221;\u5065\u5eb7\u529f\u80fd\u98df\u54c1&#8221;\u5305\u62ec\uff1a\u2460\u529f\u80fd\u6027\u663e\u793a\u98df\u54c1\uff0c\u2461\u8425\u517b\u529f\u80fd\u98df\u54c1\uff0c\u2462\u7279\u5b9a\u4fdd\u5065\u7528\u98df\u54c1\u3002<\/p>\n\n\n\n<p>\u4f8b\u5982\uff0c\u8425\u517b\u6210\u5206\u540d\u4e3a\u94be\u7684\u8425\u517b\u529f\u80fd\u98df\u54c1\uff0c\u53ef\u4ee5\u663e\u793a\u201c\u94be\u662f\u7ef4\u6301\u6b63\u5e38\u8840\u538b\u6240\u5fc5\u9700\u7684\u8425\u517b\u7d20\u201d\u7684\u6548\u679c\u3002<\/p>\n\n\n\n<p>\u53c2\u8003\uff1a\u6d88\u8d39\u8005\u4e8b\u52a1\u5c40\u300c\u5173\u4e8e\u5065\u5eb7\u548c\u8425\u517b\u7684\u98df\u54c1\u6807\u7b7e\u5236\u5ea6\u300d<\/p>\n\n\n\n<p>\u53e6\u5916\uff0c\u98df\u54c1\u53d7\u5230\u300a\u5065\u5eb7\u4fc3\u8fdb\u6cd5\u300b\u7684\u9002\u7528\u3002\u8be5\u6cd5\u7b2c65\u6761\u7b2c1\u6b3e\u7981\u6b62\u5bf9\u98df\u54c1\u8fdb\u884c\u865a\u5047\u6216\u5938\u5927\u7684\u8868\u793a\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u8fdb\u884c\u98df\u54c1\u5e7f\u544a\u65f6\uff0c\u9664\u4e86\u8981\u6ce8\u610f\u4e0d\u8fdd\u53cd\u85ac\u6a5f\u6cd5\uff0c\u8fd8\u9700\u8981\u6ce8\u610f\u4e0d\u8fdd\u53cd\u300a\u5065\u5eb7\u4fc3\u8fdb\u6cd5\u300b\u3002<\/p>\n\n\n\n<h2 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%E5%A4%84%E7%BD%9A%E5%92%8C%E9%80%AE%E6%8D%95%E6%9D%A1%E4%BB%B6\"><\/span>\u8fdd\u53cd\u836f\u68b0\u6cd5\u7684\u5904\u7f5a\u548c\u902e\u6355\u6761\u4ef6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%A4%84%E7%BD%9A\"><\/span>\u5904\u7f5a<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u5982\u679c\u672a\u7ecf\u8bb8\u53ef\u8fdb\u884c\u836f\u54c1\u7b49\u9500\u552e\u4e1a\u52a1\uff08\u8fdd\u53cd\u7b2c24\u6761\uff09\u6216\u9500\u552e\u672a\u6279\u51c6\u7684\u836f\u54c1\u7b49\uff08\u8fdd\u53cd\u7b2c55\u6761\u7b2c2\u6b3e\uff09\uff0c\u5c06\u88ab\u5224\u59043\u5e74\u4ee5\u4e0b\u6709\u671f\u5f92\u5211\u3001300\u4e07\u65e5\u5143\u4ee5\u4e0b\u7f5a\u91d1\uff0c\u6216\u4e24\u8005\u517c\u65bd\uff08\u7b2c84\u6761\u7b2c9\u53f7\u3001\u7b2c84\u6761\u7b2c18\u53f7\uff09\u3002<\/p>\n\n\n\n<p>\u90a3\u4e48\uff0c\u5982\u679c\u8fdd\u53cd\u4e86\u5e7f\u544a\u89c4\u5b9a\u4f1a\u600e\u6837\u5462\uff1f\u8fdd\u53cd\u836f\u68b0\u6cd5\u4e0a\u7684\u5e7f\u544a\u89c4\u5b9a\u7684\u5211\u7f5a\u4e3a2\u5e74\u4ee5\u4e0b\u6709\u671f\u5f92\u5211\u3001200\u4e07\u65e5\u5143\u4ee5\u4e0b\u7f5a\u91d1\uff0c\u6216\u4e24\u8005\u517c\u65bd\uff08\u7b2c85\u6761\u7b2c4\u6b3e\u7b2c5\u6b3e\uff09\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u6839\u636e\u4ee4\u548c\u5143\u5e74\uff082019\u5e74\uff09\u4fee\u8ba2\u7684\u836f\u68b0\u6cd5\uff0c\u5f15\u5165\u4e86\u7f5a\u6b3e\u5236\u5ea6\u3002<\/p>\n\n\n\n<p>\u56e0\u6b64\uff0c\u5982\u679c\u8fdb\u884c\u865a\u5047\u6216\u5938\u5927\u7684\u5e7f\u544a\uff08\u8fdd\u53cd\u7b2c66\u6761\u7b2c1\u6b3e\uff09\uff0c\u53ef\u80fd\u4f1a\u88ab\u5904\u4ee5\u9ad8\u989d\u7f5a\u6b3e\uff08\u8fdd\u53cd\u671f\u95f4\u9500\u552e\u989d\u76844.5%\uff09\u3002<\/p>\n\n\n\n<p>\u53c2\u8003\uff1a<a href=\"https:\/\/monolith-law.jp\/?p=49848\" 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<p>\u6b64\u5916\uff0c\u5982\u679c\u8fdd\u53cd\u9500\u552e\u89c4\u5b9a\u6216\u5e7f\u544a\u89c4\u5b9a\uff0c\u53ef\u80fd\u4f1a\u53d7\u5230\u505c\u6b62\u547d\u4ee4\u6216\u8425\u4e1a\u8bb8\u53ef\u88ab\u53d6\u6d88\u7b49\u884c\u653f\u5904\u7f5a\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%80%AE%E6%8D%95%E6%9D%A1%E4%BB%B6\"><\/span>\u902e\u6355\u6761\u4ef6<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>\u90a3\u4e48\uff0c\u5982\u679c\u8fdd\u53cd\u4e86\u836f\u68b0\u6cd5\u7684\u89c4\u5b9a\uff0c\u4f1a\u88ab\u902e\u6355\u5417\uff1f<\/p>\n\n\n\n<p>\u902e\u6355\u7684\u6761\u4ef6\u662f\u6709\u2460\u902e\u6355\u7684\u7406\u7531\u548c\u2461\u902e\u6355\u7684\u5fc5\u8981\u6027\u3002\u902e\u6355\u7684\u7406\u7531\u7b80\u5355\u6765\u8bf4\uff0c\u5c31\u662f\u5b58\u5728\u53ef\u4ee5\u5211\u7f5a\u7684\u884c\u4e3a\u3002<\/p>\n\n\n\n<p>\u902e\u6355\u7684\u5fc5\u8981\u6027\u662f\u5b58\u5728\u9003\u4ea1\u7b49\u98ce\u9669\uff0c\u4f46\u88ab\u5224\u65ad\u4e3a\u65e0\u902e\u6355\u5fc5\u8981\u6027\u7684\u60c5\u51b5\u5e76\u4e0d\u591a\u3002<\/p>\n\n\n\n<p>\u5982\u524d\u6240\u8ff0\uff0c\u8fdd\u53cd\u836f\u68b0\u6cd5\u4e0a\u7684\u9500\u552e\u89c4\u5b9a\u548c\u5e7f\u544a\u89c4\u5b9a\u662f\u5211\u7f5a\u7684\u5bf9\u8c61\u3002\u56e0\u6b64\uff0c\u5982\u679c\u8fdd\u53cd\u4e86\u8fd9\u4e9b\u89c4\u5b9a\uff0c\u5b58\u5728\u902e\u6355\u7684\u7406\u7531\uff0c\u53ef\u80fd\u4f1a\u88ab\u902e\u6355\u3002<\/p>\n\n\n\n<p>\u7279\u522b\u662f\u5173\u4e8e\u5e7f\u544a\u89c4\u5b9a\uff0c\u662f\u201c\u4f55\u4eba\u201d\u89c4\u5b9a\uff0c\u5373\u9002\u7528\u4e8e\u6240\u6709\u4eba\u3002\u56e0\u6b64\uff0c\u5982\u679c\u53d1\u5e03\u8fdd\u53cd\u836f\u68b0\u6cd5\u7684\u5e7f\u544a\uff0c\u65e0\u8bba\u6d89\u53ca\u8be5\u5e7f\u544a\u7684\u4eba\u662f\u8c01\uff0c\u53ea\u8981\u72af\u7f6a\u6210\u7acb\uff0c\u5c31\u6709\u53ef\u80fd\u88ab\u902e\u6355\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E9%81%BF%E5%85%8D%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%E8%A6%81%E7%82%B9\"><\/span>\u907f\u514d\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u8981\u70b9<span 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class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E6%80%BB%E7%BB%93%EF%BC%9A%E5%A6%82%E6%9E%9C%E6%8B%85%E5%BF%83%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%EF%BC%88Pharmaceuticals_and_Medical_Devices_Act%EF%BC%89%EF%BC%8C%E5%B0%B1%E5%BA%94%E5%92%A8%E8%AF%A2%E5%BE%8B%E5%B8%88\"><\/span>\u603b\u7ed3\uff1a\u5982\u679c\u62c5\u5fc3\u8fdd\u53cd\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08Pharmaceuticals and Medical Devices Act\uff09\uff0c\u5c31\u5e94\u54a8\u8be2\u5f8b\u5e08<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u7684\u76d1\u7ba1\u8303\u56f4\u5e7f\u6cdb\uff0c\u6709\u65f6\u53ef\u80fd\u5728\u4e0d\u77e5\u4e0d\u89c9\u4e2d\u8fdd\u53cd\u4e86\u6cd5\u89c4\u3002\u81ea\u6211\u5224\u65ad\u662f\u5426\u8fdd\u53cd\u4e86\u300a\u65e5\u672c\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\u53ef\u80fd\u4f1a\u6709\u56f0\u96be\uff0c\u56e0\u6b64\uff0c\u5982\u679c\u6709\u4efb\u4f55\u4e0d\u5b89\uff0c\u6211\u4eec\u5efa\u8bae\u60a8\u54a8\u8be2\u4e13\u4e1a\u7684\u5f8b\u5e08\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\u5177\u6709\u9ad8\u5ea6\u5c08\u696d\u6027\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\u5c0d\u6d88\u8cbb\u8005\uff08D2C\uff09\u7684\u88dc\u5145\u5291\u88fd\u9020\u5546\u3001\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 noopener\">https:\/\/monolith.law\/operationofmedia[ja]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u5728\u5236\u836f\u516c\u53f8\u548c\u836f\u5e97\u7b49\u7ecf\u8425\u533b\u836f\u54c1\u7b49\u4ea7\u54c1\u7684\u4f01\u4e1a\u4e2d\uff0c\u65e5\u5e38\u90fd\u4f1a\u8fdb\u884c\u65e5\u672c\u836f\u4e8b\u6cd5\uff08Japanese Pharmaceutical Affairs Law\uff09\u7684\u68c0\u67e5\uff0c\u4f46\u662f\uff0c\u53d7\u836f\u4e8b\u6cd5\u89c4\u5b9a\u7684\u5e76\u4e0d\u4ec5\u9650\u4e8e\u8fd9\u4e9b\u4f01\u4e1a\u3002\u7531\u4e8e\u5176\u89c4\u5b9a\u8303\u56f4\u5e7f\u6cdb\uff0c\u56e0\u6b64\u4e5f\u6709\u4e0d\u77e5\u9053\u81ea\u5df1\u662f\u53d7\u89c4\u5b9a\u5bf9\u8c61\u800c\u8fdd\u53cd\u836f\u4e8b\u6cd5\u7684\u60c5\u51b5\u3002 \u672c\u6587\u5c06\u8be6\u7ec6\u89e3\u91ca\u5982\u4f55\u907f\u514d\u610f\u5916\u8fdd\u53cd\u836f\u4e8b\u6cd5\uff0c\u4ee5\u53ca\u8fdd\u53cd\u6cd5\u89c4\u540e\u7684\u5904\u7f5a\u548c\u907f\u514d\u8fdd\u89c4\u7684\u8981\u70b9\u3002 \u4f55\u4e3a\u201c\u836f\u673a\u6cd5\u201d \u836f\u673a\u6cd5\u662f\u4e00\u90e8\u5173\u4e8e\u533b\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u7b49\u5fc5\u8981\u89c4\u5b9a\u7684\u6cd5 [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":66020,"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-cn\/wp-json\/wp\/v2\/posts\/63173"}],"collection":[{"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/comments?post=63173"}],"version-history":[{"count":3,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/posts\/63173\/revisions"}],"predecessor-version":[{"id":66022,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/posts\/63173\/revisions\/66022"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/media\/66020"}],"wp:attachment":[{"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/media?parent=63173"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/categories?post=63173"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/monolith.law\/zh-cn\/wp-json\/wp\/v2\/tags?post=63173"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}