{"id":1971,"date":"2025-01-24T08:01:10","date_gmt":"2025-01-24T08:01:10","guid":{"rendered":"https:\/\/tplaw.asia\/%e6%9c%aa%e5%88%86%e7%b1%bb\/%e6%b3%b0%e5%b9%b3%e8%a7%a3%e8%af%bb%ef%bd%9c%e6%b3%b0%e5%9b%bd%e6%8a%95%e8%b5%84%e7%bb%8f%e8%90%a5%e5%ae%9e%e5%8a%a1%e4%b9%8bfda%e6%b3%a8%e5%86%8c\/"},"modified":"2025-01-24T08:01:10","modified_gmt":"2025-01-24T08:01:10","slug":"%e6%b3%b0%e5%b9%b3%e8%a7%a3%e8%af%bb%ef%bd%9c%e6%b3%b0%e5%9b%bd%e6%8a%95%e8%b5%84%e7%bb%8f%e8%90%a5%e5%ae%9e%e5%8a%a1%e4%b9%8bfda%e6%b3%a8%e5%86%8c","status":"publish","type":"post","link":"https:\/\/tplaw.asia\/zh-hans\/legal-insights-cn\/%e6%b3%b0%e5%b9%b3%e8%a7%a3%e8%af%bb%ef%bd%9c%e6%b3%b0%e5%9b%bd%e6%8a%95%e8%b5%84%e7%bb%8f%e8%90%a5%e5%ae%9e%e5%8a%a1%e4%b9%8bfda%e6%b3%a8%e5%86%8c\/","title":{"rendered":"\u6cf0\u5e73\u89e3\u8bfb\uff5c\u6cf0\u56fd\u6295\u8d44\u7ecf\u8425\u5b9e\u52a1\u4e4bFDA\u6ce8\u518c"},"content":{"rendered":"

\u5f15 \u8a00<\/strong><\/h4>\n

\u636e\u6cf0\u56fd\u300a\u4e16\u754c\u65e5\u62a5\u300b\u62a5\u9053\uff0c\u8fd1\u65e5\u6cf0\u56fd\u98df\u54c1\u548c\u836f\u7269\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administration, FDA\uff09\u8054\u5408\u6d88\u8d39\u8005\u4fdd\u62a4\u72af\u7f6a\u6291\u5236\u5385\u7a81\u51fb\u68c0\u67e5\u591a\u5bb6\u4e2d\u56fd\u8d85\u5e02\uff0c\u53d1\u73b0\u5305\u62ec\u4fdd\u5065\u54c1\u548c\u5316\u5986\u54c1\u5728\u5185\u7684\u591a\u79cd\u975e\u6cd5\u5546\u54c1\u3002\u6839\u636e\u6cf0\u56fd\u76f8\u5173\u6cd5\u5f8b\u89c4\u5b9a\uff0c\u6d89\u6848\u4f01\u4e1a\u5747\u53ef\u80fd\u9762\u4e34\u5927\u989d\u7f5a\u6b3e\u3002*<\/p>\n

\u56e0\u6b64\uff0c\u4e3a\u964d\u4f4e\u5728\u6cf0\u56fd\u6295\u8d44\u7ecf\u8425\u7684\u5408\u89c4\u98ce\u9669\uff0c\u6211\u4eec\u5efa\u8bae\u5728\u6cf0\u7684\u5916\u8d44\u4f01\u4e1a\u6839\u636e\u6cd5\u5b9a\u8981\u6c42\u7533\u8bf7\u5e76\u5b8c\u6210FDA\u6ce8\u518c\u3002<\/p>\n

\n

01
\n<\/strong>\u7b80\u4ecb<\/strong><\/h4>\n

FDA\u662f\u6cf0\u56fd\u98df\u54c1\u548c\u836f\u7269\u76d1\u7763\u7ba1\u7406\u5c40\u7684\u7f29\u5199\uff0c\u8be5\u673a\u6784\u8d1f\u8d23\u76d1\u7ba1\u5f71\u54cd\u5065\u5eb7\u548c\u5b89\u5168\u7684\u5546\u54c1\uff0c\u4ece\u800c\u4fdd\u62a4\u6d88\u8d39\u8005\u3002\u4efb\u4f55\u62df\u5728\u6cf0\u56fd\u9500\u552e\u7684\u5546\u54c1\u5728\u4e0a\u5e02\u524d\u90fd\u5fc5\u987b\u7ecf\u8fc7FDA\u7684\u8d28\u91cf\u548c\u5b89\u5168\u68c0\u67e5\u3002<\/p>\n

\u7533\u8bf7FDA\u6ce8\u518c\u5bf9\u4f01\u4e1a\u672c\u8eab\u540c\u6837\u5177\u6709\u91cd\u8981\u610f\u4e49\uff0c\u5176\u6709\u52a9\u4e8e\u786e\u4fdd\u5546\u54c1\u7b26\u5408\u6709\u6548\u6027\u3001\u8d28\u91cf\u548c\u6d88\u8d39\u8005\u5b89\u5168\u6807\u51c6\uff0c\u5e76\u589e\u5f3a\u53ef\u4fe1\u5ea6\u3002<\/p>\n

\n

02
\n<\/strong>\u7533\u8bf7\u4eba\u53ca\u7533\u8bf7\u4ea7\u54c1<\/strong><\/h4>\n

1.\u00a0<\/strong>\u7533\u8bf7\u4eba<\/strong><\/p>\n

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2.\u00a0<\/strong>\u5e94\u7533\u8bf7\u7684\u4ea7\u54c1\u7c7b\u522b<\/strong><\/p>\n

FDA\u8d1f\u8d23\u76d1\u7ba1\u6cf0\u56fd\u5e02\u573a\u4e0a\u7684\u4e0b\u5217\u5546\u54c1\uff08\u65e0\u8bba\u5728\u6cf0\u56fd\u56fd\u5185\u751f\u4ea7\u6216\u8005\u8fdb\u53e3\uff09:<\/p>\n

    \n
  • \u98df\u54c1<\/li>\n
  • \u533b\u7597\u5668\u68b0<\/li>\n
  • \u5316\u5986\u54c1<\/li>\n
  • \u6709\u5bb3\u7269\u8d28<\/li>\n
  • \u7528\u4e8e\u533b\u7597\u548c\u7814\u7a76\u7684\u81f4\u763e\u836f\u7269<\/li>\n
  • \u836f\u54c1<\/li>\n
  • \u8349\u836f\u4ea7\u54c1<\/li>\n<\/ul>\n
    \n

    03
    \n<\/strong>\u6ce8\u518c\u4e8b\u9879<\/strong><\/h4>\n

    1.\u00a0<\/strong>\u751f\u4ea7\u8bbe\u65bd\u5408\u89c4\u6027<\/strong><\/p>\n

    \u7533\u8bf7\u4eba\u4f7f\u7528\u7684\u751f\u4ea7\u8bbe\u65bd\u5fc5\u987b\u7b26\u5408\u826f\u597d\u751f\u4ea7\u89c4\u8303(Good Manufacturing Practices, GMP)\u3002\u539f\u5219\u4e0a\uff0c\u8fd9\u4e9b\u8bbe\u65bd\u6240\u5728\u5730\u533a\u7684\u516c\u5171\u536b\u751f\u529e\u516c\u5ba4\u8d1f\u8d23\u73b0\u573a\u68c0\u67e5\u548c\u7b7e\u53d1\u6279\u51c6\u6587\u4e66\u3002<\/p>\n

    2.\u00a0<\/strong>FDA\u6ce8\u518c<\/strong><\/p>\n

    \u53e6\u5916\uff0c\u7533\u8bf7\u4eba\u9700\u8981\u5411FDA\u7533\u8bf7\u6279\u51c6\u53f7\u3002\u4e3a\u83b7\u5f97\u8be5\u6279\u51c6\u53f7\uff0c\u7533\u8bf7\u4eba\u5fc5\u987b\u786e\u4fdd\u4f7f\u7528\u7684\u539f\u6750\u6599\u7b26\u5408\u76f8\u5e94\u7684\u8d28\u91cf\u6807\u51c6\u3002<\/p>\n

    \n

    04
    \n<\/strong>\u672a\u6ce8\u518c\u4e4b\u6cd5\u5f8b\u98ce\u9669<\/strong><\/h4>\n

    1.<\/strong>\u5904\u7f5a<\/strong><\/p>\n

    \u4efb\u4f55\u672a\u5c65\u884cFDA\u6ce8\u518c\u4e49\u52a1\u7684\u516c\u53f8\u5747\u53ef\u80fd\u9762\u4e34\u5927\u989d\u7f5a\u6b3e\uff0c\u76f8\u5173\u8d23\u4efb\u4eba\u5458\u8fd8\u53ef\u80fd\u88ab\u5224\u5904\u76d1\u7981\u3002<\/p>\n

    \u4f8b\u5982\uff0c\u6839\u636e1967\u5e74\u300a\u836f\u54c1\u6cd5\u300b\u7b2c101\u6761\u7684\u89c4\u5b9a\uff0c\u672a\u7ecf\u6388\u6743\u751f\u4ea7\u3001\u9500\u552e\u3001\u8fdb\u53e3\u6216\u5206\u9500\u836f\u54c1\u7684\uff0c\u53ef\u80fd\u9762\u4e34\u6700\u9ad85\u5e74\u7684\u76d1\u7981\u548c\u6700\u9ad810,000\u6cf0\u94e2\u7684\u7f5a\u6b3e\u3002\u6b64\u5916\uff0c\u4f01\u4e1a\u53ef\u80fd\u56e0\u6b64\u88ab\u540a\u9500\u8425\u4e1a\u6267\u7167\u3002<\/p>\n

    2.\u00a0<\/strong>\u4ea7\u54c1\u8d23\u4efb\u7d22\u8d54<\/strong><\/p>\n

    \u7531\u4e8eFDA\u6ce8\u518c\u53ef\u4ee5\u8bc1\u660e\u76f8\u5173\u5546\u54c1\u7b26\u5408\u5b89\u5168\u6807\u51c6\uff0c\u56e0\u6b64\u5728\u4ea7\u54c1\u8d23\u4efb\u6848\u4ef6\u4e2d\u5b58\u5728\u4f18\u52bf\uff0c\u53ef\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u51cf\u8f7b\u8bc1\u660e\u8d23\u4efb\u3002\u5982\u679c\u672a\u83b7\u5f97\u6ce8\u518c\uff0c\u4f01\u4e1a\u5728\u8d23\u4efb\u8bc1\u660e\u65b9\u9762\u5b58\u5728\u52a3\u52bf\u3002<\/p>\n

    3.\u00a0<\/strong>\u77e5\u8bc6\u4ea7\u6743\u98ce\u9669<\/strong><\/p>\n

    \u7533\u8bf7FDA\u6ce8\u518c\u6d89\u53ca\u77e5\u8bc6\u4ea7\u6743\u5ba1\u67e5\uff0c\u4f01\u4e1a\u53ef\u636e\u6b64\u4e86\u89e3\u5176\u5546\u54c1\u662f\u5426\u5b58\u5728\u6f5c\u5728\u7684\u4fb5\u6743\u98ce\u9669\u3002<\/p>\n

    \u4f8b\u5982\uff0c\u4e00\u5bb6\u516c\u53f8\u7814\u53d1\u4e86\u4e00\u79cd\u6d89\u5acc\u4fb5\u72af\u4ed6\u4eba\u4e13\u5229\u6743\u7684\u836f\u7269\uff0c\u4e13\u5229\u6743\u5229\u4eba\u53ef\u4ee5\u8d28\u7591\u5176FDA\u7684\u6279\u51c6\uff0c\u4ece\u800c\u63a8\u8fdf\u6216\u963b\u6b62\u8be5\u6ce8\u518c\u3002<\/p>\n

    \n

    05
    \n<\/strong>\u5176\u4ed6<\/strong><\/h4>\n

    FDA\u6ce8\u518c\u5b58\u5728\u6709\u6548\u671f\u9650\u5236\u3002\u4e0d\u540c\u5546\u54c1\u7c7b\u522b\u7684\u6ce8\u518c\u6709\u6548\u671f\uff0c\u5747\u6709\u6240\u4e0d\u540c\u3002\u4f01\u4e1a\u9700\u8981\u5bc6\u5207\u5173\u6ce8\u5bf9\u5e94\u4ea7\u54c1\u7684\u6709\u6548\u671f\u9650\uff0c\u53ca\u65f6\u66f4\u65b0FDA\u6ce8\u518c\u3002<\/p>\n

    \u83b7\u5f97FDA\u6279\u51c6\u5bf9\u65b0\u4f01\u4e1a\u800c\u8a00\u53ef\u80fd\u662f\u4e00\u4e2a\u6311\u6218\uff0c\u4f46\u4e3a\u5b9e\u73b0\u4f01\u4e1a\u7684\u5408\u89c4\u8fd0\u8425\u4e0e\u957f\u671f\u53d1\u5c55\uff0cFDA\u6ce8\u518c\u4f9d\u65e7\u662f\u5177\u6709\u9ad8\u5ea6\u4ef7\u503c\u4e14\u5fc5\u8981\u7684\u3002<\/p>\n

    \n

    \u6ce8\u91ca\uff1a<\/p>\n

    *\u53c2\u89c1 https:\/\/mp.weixin.qq.com\/s\/iRwSdRUAenz30E7utakdOw\uff0c2024\u5e7409\u670826\u65e5\u6700\u540e\u8bbf\u95ee\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

    \u5f15 \u8a00 \u636e\u6cf0\u56fd\u300a\u4e16\u754c\u65e5\u62a5\u300b\u62a5\u9053\uff0c\u8fd1\u65e5\u6cf0\u56fd\u98df\u54c1\u548c\u836f\u7269\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administra […]\n","protected":false},"author":1,"featured_media":1828,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"class_list":["post-1971","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal-insights-cn"],"_links":{"self":[{"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/posts\/1971","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/comments?post=1971"}],"version-history":[{"count":0,"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/posts\/1971\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/media\/1828"}],"wp:attachment":[{"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/media?parent=1971"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/categories?post=1971"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tplaw.asia\/zh-hans\/wp-json\/wp\/v2\/tags?post=1971"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}