{"id":1058,"date":"2018-04-12T12:02:15","date_gmt":"2018-04-12T10:02:15","guid":{"rendered":"http:\/\/www.trusticert.com\/?page_id=1058"},"modified":"2020-10-15T15:07:26","modified_gmt":"2020-10-15T13:07:26","slug":"deeming-2","status":"publish","type":"page","link":"https:\/\/staging-vaping.trusticert.com\/zh-hans\/regulations\/deeming-2\/","title":{"rendered":"Deeming"},"content":{"rendered":"

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DEEMING<\/strong><\/h1><\/div>
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Deeming\u4e00\u8bcd\u88ab\u7528\u6765\u4ee3\u6307\u7f8e\u56fd\u73b0\u884c\u7ba1\u5236\u4f9b\u4eba\u7c7b\u6d88\u8d39\u7684\u70df\u8349\u5236\u54c1\u7684\u7acb\u6cd5\u3002\u5728\u6b64\uff0c\u70df\u8349\u5236\u54c1\u5305\u62ec\u4e86\u7535\u5b50\u70df\u4ea7\u54c1\uff0c\u66f4\u5e7f\u6cdb\u7684\u6765\u8bf4\uff0c\u6240\u6709\u80fd\u591f\u91ca\u653e\u5c3c\u53e4\u4e01\u7684\u7535\u5b50\u4ea7\u54c1\uff08ENDS\uff09\u53ca\u5176\u7ec4\u6210\u90e8\u5206\u3002<\/h2><\/div>

\u76ee\u524d\u7684\u201c\u70df\u8349\u7ba1\u5236\u6cd5\u201d\u7531\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u8d1f\u8d23\u6267\u884c\uff0c\u7ba1\u5236\u5728\u7f8e\u56fd\u751f\u4ea7\u3001\u5206\u9500\u3001\u96f6\u552e\u7684\u70df\u8349\u53ca\u76f8\u5173\u5236\u54c1\u3002<\/p>\n

\u867d\u7136\u81f3\u4eca\uff0c\u7f8e\u56fd\u653f\u5e9c\u5bf9\u5176\u5e02\u573a\u4e0a\u7535\u5b50\u70df\u4ea7\u54c1\u7ba1\u5236\u7684\u5177\u4f53\u8981\u6c42\u4f9d\u7136\u5904\u4e8e\u5f85\u5b9a\u72b6\u6001\uff0c\u4f46FDA\u5df2\u62df\u5b9a\u4e86\u7535\u5b50\u70df\u4ea7\u54c1\u83b7\u5f97\u7f8e\u56fd\u5e02\u573a\u6295\u653e\u8bb8\u53ef\u7684\u5927\u81f4\u7684\u6d41\u7a0b\u3001\u5468\u671f\u4ee5\u53ca\u4ef7\u683c\uff0c\u867d\u7136\u5177\u4f53\u7ec6\u8282\u5728\u540e\u671f\u8fd8\u6709\u8c03\u6574\u548c\u53d8\u52a8\u7684\u53ef\u80fd\u3002\u4e0d\u4e45\u524d\uff0cFDA\u4e13\u5458Scott Gottlieb\u5df2\u5bf9\u5916<\/span>\u5ba3\u5e03<\/span><\/a>\u4e86\u4e00\u9879\u65b0\u7684\u70df\u8349\u53ca\u542b\u5c3c\u53e4\u4e01\u5236\u54c1\u6cd5\u89c4\u3002<\/span><\/p>\n<\/div>

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\u6ce8\u610f\uff1aPMTA\u63d0\u4ea4\u7684\u622a\u6b62\u65e5\u671f\u76ee\u524d\u6b63\u5728\u8ba8\u8bba\u4e2d\uff0c\u6709\u53ef\u80fd\u63d0\u524d\u81f32020\u5e745\u670811\u65e5\u3002<\/strong><\/h2><\/div>
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\u4ee5\u4e0a\u7ed9\u51fa\u7684\u65f6\u95f4\u8f74\u53ea\u4f5c\u7528\u4e8e\u5c0f\u578b(\u5168\u804c\u5458\u5de5\u5728150\u4eba\u4ee5\u4e0b\u4ee5\u53ca\u5e74\u603b\u6536\u5165\u572850\u4e07\u7f8e\u5143\u4ee5\u4e0b\uff09\u751f\u4ea7\/\u8fdb\u53e3\u516c\u53f8\u57282016\u5e748\u67088\u65e5\u524d\u6295\u653e\u5728\u7f8e\u56fd\u5e02\u573a\u4e0a\u9500\u552e\u7684\u4ea7\u54c1\u3002\u5b9e\u9645\u4e0a\uff0cFDA\u6839\u636e\u4ea7\u54c1\u4e0a\u5e02\u9500\u552e\u65f6\u95f4\u7684\u4e0d\u540c\u4ee5\u53ca\u751f\u4ea7\/\u9500\u552e\u516c\u53f8\u89c4\u6a21\u5927\u5c0f\u7684\u4e0d\u540c\u7ed9\u51fa\u4e86\u4e0d\u540c\u7684\u65f6\u95f4\u8981\u6c42\uff1a\u5177\u4f53\u7ec6\u8282\u8bf7\u53c2\u8003\u4e0b\u6587\u3002<\/p>\n<\/div>

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\u4ee5\u4e0b\u4e3a\u5173\u4e8eFDA\u6307\u5b9a\u76846\u4e2a\u5fc5\u8981\u6b65\u9aa4\u7684\u8be6\u7ec6\u4fe1\u606f\uff1a<\/b><\/h3><\/div>
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1. \u4f01\u4e1a\u6ce8\u518c\u4ee5\u53ca\u4ea7\u54c1\u540d\u5355\u63d0\u4ea4<\/b><\/h3><\/div>
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FDA\u8981\u6c42\u5728\u7f8e\u56fd\u751f\u4ea7\u6216\u52a0\u5de5\u7535\u5b50\u70df\u4ea7\u54c1\u7684\u4f01\u4e1a\u63d0\u4ea4\u4e00\u4efd\u516c\u53f8\u548c\u5176\u8d1f\u8d23\u4eba\u7684\u4fe1\u606f\u6587\u4ef6\u4ee5\u53ca\u6240\u6709\u4ea7\u54c1\u540d\u5355\u3002<\/p>\n

\u622a\u81f3\u65e5\u671f:<\/p>\n<\/div>\n

\n\n\n\n\n\n\n
\u4ea7\u54c1\u4e0a\u5e02\u65e5\u671f<\/b><\/th>\n\u5927\u578b\u4f01\u4e1a<\/b><\/th>\n\u5c0f\u578b\u4f01\u4e1a<\/b><\/th>\n<\/tr>\n<\/thead>\n
\u57282016\u5e748\u67088\u65e5\u524d\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n2017\u5e7410\u670812\u65e5<\/td>\n<\/tr>\n
\u57282016\u5e748\u67088\u65e5\u540e\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n\u5728\u4ea7\u54c1\u6279\u91cf\u751f\u4ea7\u524d<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
<\/div>
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\u60a8\u7684\u4ea7\u54c1\u662f\u5426\u57282016\u5e748\u67088\u65e5\u4e4b\u524d\u6295\u653e\u5230\u7f8e\u56fd\u5e02\u573a\uff1f \u60a8\u662f\u5426\u5df2\u7ecf\u5728\u622a\u81f3\u65e5\u671f\u524d\u5b8c\u6210\u4e86\u8fd9\u4e00\u6b65? \u5982\u679c\u60a8\u6709\u4efb\u4f55\u7591\u95ee\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u3002<\/p>\n<\/div>

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2. \u5065\u5eb7\u4fe1\u606f\u6587\u6863
\n<\/b><\/h3><\/div>
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\u5065\u5eb7\u4fe1\u606f\u6587\u6863\u662f\u6307\u4e00\u4efd\u96c6\u5408\u4e86\u4ea7\u54c1\u672c\u8eab\u4ee5\u53ca\u5176\u6240\u6709\u7ec4\u6210\u6210\u5206\u7684\u6bd2\u7406\u5b66\u4fe1\u606f\u548c\u5bf9\u5065\u5eb7\u5f71\u54cd\u7684\u6587\u6863.<\/p>\n

\u76ee\u524dFDA\u8981\u6c42\u63d0\u4ea4\u57282009\u5e746\u670823\u65e5\u81f32009\u5e7412\u670831\u65e5\u95f4\u5236\u4f5c\u7684\u5065\u5eb7\u4fe1\u606f\u6587\u6863, \u5728\u6b64\u65e5\u671f\u4e4b\u540e\u5236\u4f5c\u7684\u6587\u6863\u5728\u540e\u671f\u4e5f\u5c06\u4f1a\u88ab\u8981\u6c42\u63d0\u4ea4.<\/p>\n

\u622a\u81f3\u65e5\u671f:<\/p>\n<\/div>\n

\n\n\n\n\n\n\n
\u4ea7\u54c1\u4e0a\u5e02\u65e5\u671f<\/b><\/th>\n\u5927\u578b\u4f01\u4e1a<\/b><\/th>\n\u5c0f\u578b\u4f01\u4e1a<\/b><\/th>\n<\/tr>\n<\/thead>\n
\u57282016\u5e748\u67088\u65e5\u524d\u4e0a\u5e02\u7684\u4ea7\u54c1 <\/b><\/td>\n2017\u5e742\u67088\u65e5<\/td>\n2017\u5e7411\u67088\u65e5(\u5728\u7f8e\u56fd\u906d\u53d7\u5230\u81ea\u7136\u707e\u5bb3\u5f71\u54cd\u7684\u5730\u533a\u53ef\u63a8\u8fdf\u52302018\u5e745\u67088\u65e5)<\/td>\n<\/tr>\n
\u57282016\u5e748\u67088\u65e5\u540e\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n\u4ea7\u54c1\u4e0a\u5e02\u9500\u552e\u524d90\u5929<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
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\u5982\u679c\u60a8\u8fd8\u6ca1\u6709\u63d0\u4ea4\u5065\u5eb7\u4fe1\u606f\u6587\u6863\u6216\u8005\u60a8\u6709\u4efb\u4f55\u5176\u4ed6\u7591\u95ee\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\uff0c\u6211\u4eec\u5c06\u7aed\u8bda\u4e3a\u60a8\u63d0\u4f9b\u5e2e\u52a9\u3002<\/p>\n<\/div>

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3. \u4ea7\u54c1\u6210\u5206\u8868<\/b><\/h3><\/div>
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FDA\u8981\u6c42\u751f\u4ea7\u5546\u548c\u8fdb\u53e3\u5546\u4e3a\u6bcf\u79cd\u4ea7\u54c1\u63d0\u4ea4\u5176\u5b8c\u6574\u6210\u5206\u6e05\u5355\uff0c\u5305\u62ec\u5316\u5408\u7269\u548c\u6dfb\u52a0\u5242\uff0c\u6570\u91cf\u548c\u76f8\u5173\u529f\u6548\u3002<\/p>\n

\u622a\u81f3\u65e5\u671f\uff1a<\/p>\n<\/div>\n

\n\n\n\n\n\n\n
\u4ea7\u54c1\u4e0a\u5e02\u65e5\u671f<\/b><\/th>\n\u5927\u578b\u516c\u53f8<\/b><\/th>\n\u5c0f\u578b\u516c\u53f8<\/b><\/th>\n<\/tr>\n<\/thead>\n
\u57282016\u5e748\u67088\u65e5\u524d\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n2018\u5e745\u67088<\/td>\n2018\u5e7411\u67088\u65e5<\/td>\n<\/tr>\n
\u57282016\u5e748\u67088\u65e5\u540e\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n\u4ea7\u54c1\u4e0a\u5e02\u9500\u552e\u524d90\u5929<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
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\u5bf9\u4e8e\u57282016\u5e748\u67088\u65e5\u4e4b\u524d\u4e0a\u5e02\u9500\u552e\u7684\u7535\u5b50\u70df\u4ea7\u54c1\uff0c\u63d0\u4ea4\u6210\u5206\u8868\u7684\u622a\u6b62\u65e5\u671f\u8feb\u5728\u7709\u6025\u3002\u4e3a\u4e86\u80fd\u591f\u5728\u7f8e\u56fd\u7ee7\u7eed\u5408\u6cd5\u9500\u552e\u60a8\u7684\u4ea7\u54c1\uff0c\u5236\u4f5c\u7b26\u5408\u8981\u6c42\u7684\u4ea7\u54c1\u6210\u5206\u8868\u5c06\u53d8\u5f97\u81f3\u4e3a\u5173\u952e\u3002\u5982\u679c\u60a8\u5bf9\u6b64\u6709\u4efb\u4f55\u7591\u95ee\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u3002<\/p>\n<\/div>

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4. \u4ea7\u54c1\u5305\u88c5\u8981\u6c42<\/b><\/h3><\/div>
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\u4ece2018\u5e748\u670810\u65e5\u5f00\u59cb\uff0c\u7f8e\u56fd\u5c06\u51fa\u53f0\u7535\u5b50\u70df\u4ea7\u54c1\u7684\u5305\u88c5\u7684\u65b0\u8981\u6c42\u3002\u622a\u81f3\u5230 2018\u5e749\u670810\u65e5\u524d\uff0c\u4ecd\u53ef\u5408\u6cd5\u9500\u552e\u5e26\u6709\u65e7\u5305\u88c5\u7684\u4ea7\u54c1\u3002<\/p>\n

\u622a\u81f3\u65e5\u671f\uff1a<\/p>\n<\/div>\n

\n\n\n\n\n\n\n
<\/th>\n\u5927\u578b\u4f01\u4e1a<\/b><\/th>\n\u5c0f\u578b\u4f01\u4e1a<\/b><\/th>\n<\/tr>\n<\/thead>\n
\u65b0\u5305\u88c5\u89c4\u5b9a<\/b><\/td>\n2018\u5e748\u670810\u53f7<\/td>\n<\/tr>\n
\u65e7\u5305\u88c5\u5408\u6cd5\u9500\u552e<\/b><\/td>\n2018\u5e749\u670810\u53f7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
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\u60a8\u5bf9\u65b0\u5305\u88c5\u7684\u89c4\u5b9a\u5df2\u7ecf\u6709\u4e86\u89e3\u4e86\u5417\uff1f\u8bf7\u8054\u7cfb\u6211\u4eec\u7684\u4e13\u4e1a\u4eba\u58eb\u6765\u89e3\u7b54\u60a8\u7684\u7591\u95ee\u3002<\/p>\n<\/div>

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5. \u6709\u5bb3\u53ca\u6f5c\u5728\u6709\u5bb3\u7269\u8d28\u6587\u6863\uff08HPHC)<\/b><\/h3><\/div>
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\u76ee\u524dFDA\u8981\u6c42\u63d0\u4f9b\u7684HPHC\u6587\u6863\u662f\u6307\uff0c\u6bcf\u4e2a\u4ea7\u54c1\u4e2d\u5bf9\u5065\u5eb7\u6709\u5371\u5bb3\u6216\u8005\u6709\u6f5c\u5728\u5371\u5bb3\u7269\u8d28*HPHC\uff09\u7684\u6570\u91cf\u3002\u81f3\u4e8e\u5bf9HPHC\u7684\u5177\u4f53\u7814\u7a76\u548c\u6d4b\u91cf\u65b9\u6cd5\u8fd8\u5904\u4e8e\u5f85\u5b9a\u72b6\u6001\u3002<\/p>\n

\u622a\u81f3\u65e5\u671f\uff1a<\/p>\n<\/div>\n

\n\n\n\n\n\n\n
\u4ea7\u54c1\u4e0a\u5e02\u65e5\u671f<\/b><\/th>\n\u5927\u578b\u4f01\u4e1a<\/b><\/th>\n\u5c0f\u578b\u4f01\u4e1a<\/b><\/th>\n<\/tr>\n<\/thead>\n
\u57282016\u5e748\u67088\u65e5\u524d\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n2019\u5e7411\u67088\u65e5<\/td>\n<\/tr>\n
\u57282016\u5e748\u67088\u65e5\u540e\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n\u5f85\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
<\/div>
<\/div>
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FDA\u5bf9\u6709\u5bb3\u53ca\u6f5c\u5728\u6709\u5bb3\u7269\u8d28(HPHC)\u6587\u6863\u7684\u7684\u5177\u4f53\u8981\u6c42\u4ee5\u53ca\u622a\u81f3\u65e5\u671f\u90fd\u8fd8\u6ca1\u6709\u660e\u786e\u7684\u89c4\u5b9a\u3002 \u4f46\u662f\uff0c\u76f8\u5173\u6bd2\u7406\u5b66\u4fe1\u606f\u7684\u6536\u96c6\u548c\u5f52\u7eb3\u662f\u4e00\u4e2a\u5468\u671f\u53ca\u957f\u4e14\u7e41\u7410\u7684\u8fc7\u7a0b\u3002\u5982\u679c\u60a8\u6709\u4efb\u4f55\u9700\u8981\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u7684\u8d44\u6df1\u4e13\u5bb6\u4e3a\u60a8\u63d0\u4f9b\u5e2e\u52a9\u3002<\/span><\/p>\n<\/div>

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6. \u7535\u5b50\u70df\u4ea7\u54c1\u5e02\u573a\u6295\u653e\u7533\u8bf7\uff08PMTA)<\/b><\/h3><\/div>
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\u4efb\u4f55\u4e00\u6b3e\u7535\u5b50\u70df\u4ea7\u54c1\u5747\u9700\u8981\u83b7\u5f97FDA\u7684\u9500\u552e\u8bb8\u53ef\u540e\u65b9\u53ef\u5728\u7f8e\u56fd\u5e02\u573a\u4e0a\u6295\u653e\u9500\u552e\u3002\u800cFDA\u5219\u4f1a\u901a\u8fc7PTMA\u6587\u4ef6\u6765\u5bf9\u4ea7\u54c1\u672c\u8eab\u4ee5\u53ca\u5176\u7ec4\u6210\u6210\u5206\u7684\u8d28\u91cf\u548c\u5b89\u5168\u6027\u6765\u8fdb\u884c\u8bc4\u4f30\u3002<\/p>\n

\u622a\u81f3\u65e5\u671f\uff1a<\/p>\n<\/div>\n

\n\n\n\n\n\n\n
\u4ea7\u54c1\u4e0a\u5e02\u65e5\u671f<\/b><\/th>\n\u5927\u578b\u4f01\u4e1a<\/b><\/th>\n\u5c0f\u578b\u4f01\u4e1a<\/b><\/th>\n<\/tr>\n<\/thead>\n
\u57282016\u5e748\u67088\u65e5\u524d\u4e0a\u5e02\u7684\u4ea7\u54c1<\/b><\/td>\n2021\u5e748\u67088\u65e5 (\u6700\u65b0\u622a\u6b62\u65e5\u671f)<\/strong><\/td>\n<\/tr>\n
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