{"id":7153,"date":"2020-10-15T11:24:31","date_gmt":"2020-10-15T11:24:31","guid":{"rendered":"https:\/\/www.enago.com\/academy\/tw\/?p=7153"},"modified":"2026-08-18T14:01:23","modified_gmt":"2026-08-18T14:01:23","slug":"pharmacovigilance-post-covid-19-opportunities-and-challenges","status":"publish","type":"post","link":"https:\/\/www.enago.com\/academy\/tw\/pharmacovigilance-post-covid-19-opportunities-and-challenges\/","title":{"rendered":"\u5f8c\u75ab\u60c5\u6642\u4ee3\u7684\u85e5\u7269\u8b66\u6212\uff1a\u6a5f\u6703\u8207\u6311\u6230"},"content":{"rendered":"<p>\u6839\u64da\u4e16\u754c\u885b\u751f\u7d44\u7e54\uff08WHO\uff09\u7684\u5b9a\u7fa9\uff0c\u85e5\u7269\u8b66\u6212\uff08Pharmacovigilance\uff09\u662f\u6307\u70ba\u300c\u5075\u6e2c\u3001\u8a55\u4f30\u3001\u77ad\u89e3\u4ee5\u53ca\u9810\u9632\u85e5\u7269\u4e0d\u826f\u53cd\u61c9\u4ee5\u53ca\u4efb\u4f55\u5176\u4ed6\u8207\u85e5\u7269\u6709\u95dc\u554f\u984c\u7684\u6d3b\u52d5\u53ca\u79d1\u5b78\u3002\u300d\u85e5\u7269\u8b66\u6212\u662f WHO \u5728 1961\u5e74Thalidomide (\u6c99\u5229\u7ac7\u9081) \u9020\u6210\u5927\u91cf\u7578\u5f62\u5b30\u5152\u7684\u60b2\u5287\u5f8c\u63a8\u52d5\u7522\u751f\uff0c\u65e8\u5728\u63d0\u5347\u75c5\u4eba\u5b89\u5168\u53ca\u7167\u8b77\uff0c\u4e26\u63d0\u4f9b\u516c\u5171\u885b\u751f\u7cfb\u7d71\u5e73\u8861\u3001\u53ef\u9760\u7684\u8cc7\u8a0a\uff0c\u5f9e\u800c\u66f4\u5b8c\u5584\u5730\u8a55\u4f30\u85e5\u7269\u98a8\u96aa\u8207\u76ca\u8655\u3002<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u5e38\u898b\u554f\u984c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/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:\/\/www.enago.com\/academy\/tw\/pharmacovigilance-post-covid-19-opportunities-and-challenges\/#%E6%96%B0%E5%86%A0%E7%97%85%E6%AF%92%E7%96%AB%E6%83%85%E4%B8%8B%E8%97%A5%E7%89%A9%E8%AD%A6%E6%88%92%E7%9A%84%E8%AA%BF%E6%95%B4\" >\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u4e0b\u85e5\u7269\u8b66\u6212\u7684\u8abf\u6574<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.enago.com\/academy\/tw\/pharmacovigilance-post-covid-19-opportunities-and-challenges\/#%E8%97%A5%E7%89%A9%E8%AD%A6%E6%88%92%E5%9C%A8%E5%BE%8C%E7%96%AB%E6%83%85%E6%99%82%E4%BB%A3%E7%9A%84%E8%B2%A2%E7%8D%BB\" >\u85e5\u7269\u8b66\u6212\u5728\u5f8c\u75ab\u60c5\u6642\u4ee3\u7684\u8ca2\u737b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.enago.com\/academy\/tw\/pharmacovigilance-post-covid-19-opportunities-and-challenges\/#%E6%96%B0%E5%86%A0%E7%97%85%E6%AF%92%E7%96%AB%E6%83%85%E5%BE%8C%E8%97%A5%E7%89%A9%E8%AD%A6%E6%88%92%E7%9A%84%E8%BD%89%E5%9E%8B\" >\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u5f8c\u85e5\u7269\u8b66\u6212\u7684\u8f49\u578b<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"%E6%96%B0%E5%86%A0%E7%97%85%E6%AF%92%E7%96%AB%E6%83%85%E4%B8%8B%E8%97%A5%E7%89%A9%E8%AD%A6%E6%88%92%E7%9A%84%E8%AA%BF%E6%95%B4\"><\/span>\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u4e0b\u85e5\u7269\u8b66\u6212\u7684\u8abf\u6574<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/regulis.com\/pv\/covid-19-impact-on-pharmacovigilance\/\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">\u81e8\u5e8a\u8a66\u9a57\u57f7\u884c<\/a>\uff1a\u7531\u65bc\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u9020\u6210\u7684\u65c5\u884c\u9650\u5236\u3001\u4eba\u54e1\u9694\u96e2\u3001\u91ab\u5b78\u7814\u7a76\u4e2d\u65b7\u3001\u91ab\u7642\u4eba\u54e1\u611f\u67d3\u7b49\u554f\u984c\uff0c\u82f1\u570b (MHRA)\u3001\u6b50\u6d32 (EMA)\u3001\u6cd5\u570b (ANSM) \u548c\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40(FDA) \u5df2\u5c0d\u81e8\u5e8a\u8a66\u9a57\u7684\u85e5\u7269\u8b66\u6212\u63d0\u51fa\u65b0\u7684\u6307\u5c0e\u65b9\u91dd\uff0c\u5982\u5fc5\u9808\u512a\u5148\u5448\u5831\u672a\u9810\u671f\u56b4\u91cd\u85e5\u54c1\u4e0d\u826f\u53cd\u61c9 (SUSARs)\uff0c\u7121\u6cd5\u8207\u75c5\u4eba\u9762\u5c0d\u9762\u554f\u8a3a\u6642\u61c9\u63a1\u7528\u96fb\u8a71\u806f\u7d61\uff0c\u4e26\u4e14\u589e\u52a0\u5176\u4ed6\u85e5\u7269\u8b66\u6212\u5831\u544a\u7684\u6642\u9593\u5f48\u6027\u3002<\/p>\n<p><a href=\"https:\/\/www.gmp-compliance.org\/gmp-news\/pharmacovigilance-audits-and-inspections-during-cov19\" target=\"_blank\" rel=\"noopener noreferrer\">\u81e8\u5e8a\u8a66\u9a57\u7a3d\u6838<\/a>\uff1a\u6b50\u6d32 EMA \u4e5f\u6307\u793a\u81e8\u5e8a\u8a66\u9a57\u7a3d\u6838\u7684\u898f\u5283\u8207\u57f7\u884c\u5fc5\u9808\u8003\u616e\u98a8\u96aa\uff0c\u4e14\u512a\u5148\u57f7\u884c\u6709\u56e0\u6027 (For cause) \u7a3d\u6838\uff0c\u4e5f\u5fc5\u9808\u8861\u91cf\u9060\u7aef\u7a3d\u6838\u662f\u5426\u53ef\u884c\uff0c\u5982\u63a1\u7528\u96fb\u8a71\u3001\u8996\u983b\u548c\u96fb\u5b50\u6587\u4ef6\u7a3d\u6838\u3002<\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/public-health-threats\/coronavirus-disease-covid-19\/guidance-medicine-developers-other-stakeholders-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">\u85e5\u7269\u4e0a\u5e02<\/a>\uff1a\u70ba\u4e86\u5118\u5feb\u4fc3\u9032\u65b0\u51a0\u75c5\u6bd2\u85e5\u7269\u53ca\u75ab\u82d7\u4e0a\u5e02\uff0c\u6b50\u6d32 EMA \u5df2\u7d93\u52a0\u901f\u7528\u65bc\u6cbb\u7642\u65b0\u51a0\u75c5\u6bd2\u7684\u65b0\u85e5\u4ee5\u53ca\u8001\u85e5\u65b0\u7528 (Drug repurposing) \u7684\u5be9\u6838\u901f\u5ea6\u8207\u5f48\u6027\uff0c\u4e26\u63d0\u4f9b\u514d\u8cbb\u4e14\u66f4\u5373\u6642\u7684\u5c08\u5bb6\u8aee\u8a62\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E8%97%A5%E7%89%A9%E8%AD%A6%E6%88%92%E5%9C%A8%E5%BE%8C%E7%96%AB%E6%83%85%E6%99%82%E4%BB%A3%E7%9A%84%E8%B2%A2%E7%8D%BB\"><\/span>\u85e5\u7269\u8b66\u6212\u5728\u5f8c\u75ab\u60c5\u6642\u4ee3\u7684\u8ca2\u737b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u76ee\u524d\u6578\u7a2e\u91dd\u5c0d\u65b0\u51a0\u75c5\u6bd2\u7684\u75ab\u82d7\u3001\u65b0\u85e5\u548c\u5617\u8a66\u65b0\u7528\u7684\u8001\u85e5\u7684\u81e8\u5e8a\u8a66\u9a57\u90fd<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s40264-020-00965-w\" target=\"_blank\" rel=\"noopener noreferrer\">\u5982\u706b\u5982\u837c\u5730\u9032\u884c<\/a>\uff0c\u4e14\u6709\u7684\u5df2\u7d93\u9032\u5c55\u5230\u7b2c\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u3002\u5168\u7403\u6700\u5927\u4e14\u8207 WHO \u5408\u4f5c\u7684\u85e5\u7269\u8b66\u6212\u8cc7\u6599\u5eab VigiBase \u4e5f<a href=\"https:\/\/www.uppsalareports.org\/articles\/pharmacovigilance-in-the-age-of-covid-19\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u958b\u59cb\u6536\u5230\u4e0d\u540c\u7a0b\u5ea6\u7684\u4e0d\u826f\u53cd\u61c9<\/a>\u3002\u81e8\u5e8a\u8a66\u9a57\u6210\u529f\u7684\u85e5\u7269\u8207\u75ab\u82d7\u5c07\u88ab\u5927\u91cf\u7528\u65bc\u5168\u7403\u4eba\u53e3\uff0c\u56e0\u6b64\u6e96\u78ba\u3001\u8a73\u76e1\u7684\u7684\u85e5\u7269\u8b66\u6212\u8cc7\u6599\u66f4\u986f\u91cd\u8981\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E6%96%B0%E5%86%A0%E7%97%85%E6%AF%92%E7%96%AB%E6%83%85%E5%BE%8C%E8%97%A5%E7%89%A9%E8%AD%A6%E6%88%92%E7%9A%84%E8%BD%89%E5%9E%8B\"><\/span>\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u5f8c\u85e5\u7269\u8b66\u6212\u7684\u8f49\u578b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u56e0\u70ba\u65b0\u51a0\u75c5\u6bd2\u75ab\u60c5\u8b93\u85e5\u7269\u8b66\u6212\u5c0d\u5168\u4eba\u985e\u7684\u91cd\u8981\u6027\u5287\u589e\uff0c\u5404\u6a5f\u95dc\u4e5f\u66f4\u7a4d\u6975\u63a8\u5ee3\u4e26\u5347\u7d1a\u85e5\u7269\u8b66\u6212\uff0c\u4f8b\u5982\u82f1\u570b MHRA \u6210\u7acb\u4e86\u6536\u96c6\u6240\u6709\u65b0\u51a0\u75c5\u6bd2\u6cbb\u7642\u7684\u526f\u4f5c\u7528\u8cc7\u6599\u5eab <a href=\"https:\/\/www.pharmafile.com\/news\/548013\/mhra-launches-new-pharmacovigilance-reporting-platform-covid-19-treatments\" target=\"_blank\" rel=\"noopener noreferrer\">Yellow Card<\/a>\uff0c\u8b93\u75c5\u4eba\u8207\u91ab\u7642\u4eba\u54e1\u80fd\u66f4\u65b9\u4fbf\u5730\u63d0\u4f9b\u85e5\u7269\u8b66\u6212\u8cc7\u8a0a\u3002WHO \u4e5f\u8ddf\u5317\u6b50\u3001\u975e\u6d32\u3001\u8377\u862d\u7b49\u6578\u500b<a href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/safety_efficacy\/pharmvigi\/en\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u85e5\u7269\u76e3\u6e2c\u4e2d\u5fc3\u3001\u516c\u5171\u885b\u751f\u4e2d\u5fc3\u5408\u4f5c<\/a>\uff0c\u900f\u904e\u8a13\u7df4\u8207\u6559\u80b2\u5404\u570b\u4e3b\u7ba1\u6a5f\u95dc\u3001\u91ab\u7642\u4eba\u54e1\u3001\u4ee5\u53ca\u51fa\u7248\u5b78\u8853\u8457\u4f5c\u548c\u6587\u7ae0\u63d0\u5347\u4e16\u754c\u5404\u570b\u85e5\u7269\u8b66\u6212\u3002<\/p>\n<p>\u96a8\u8457\u75ab\u60c5\u7684\u767c\u5c55\uff0c\u8fd1\u671f\u5168\u7403\u7684\u91ab\u7642\u7522\u696d\u8da8\u52e2 (\u5982\u85e5\u7269\u4e0d\u826f\u53cd\u61c9\u96a8\u75be\u75c5\u8907\u96dc\u5ea6\u589e\u52a0\u3001\u516c\u53f8\u7e2e\u6e1b\u958b\u652f\u7684\u58d3\u529b\u3001\u5168\u7403\u6cd5\u898f\u65e5\u8da8\u8907\u96dc\u3001\u7a7f\u6234\u88dd\u7f6e\u8207\u793e\u4ea4\u5a92\u9ad4\u8b93\u5373\u6642\u8cc7\u6599\u53ef\u5f97\u6027\u589e\u52a0\u7b49\u7b49) \u4e5f\u63a8\u52d5\u8fd1\u4ee3\u85e5\u7269\u8b66\u6212\u8f49\u578b\u3002\u50b3\u7d71\u85e5\u7269\u8b66\u6212\u53ea\u662f\u5c07\u8cc7\u6599\u5448\u5831\u7d66\u4e3b\u7ba1\u6a5f\u95dc\uff0c\u6d41\u7a0b\u4e0d\u50c5\u8017\u6642\u8907\u96dc\uff0c<a href=\"https:\/\/acuvate.com\/blog\/pharmacovigilance-analytics\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u4e14\u96e3\u4ee5\u5206\u6790\u975e\u7cfb\u7d71\u5316\u8cc7\u8a0a<\/a>\u3002\u8fd1\u671f\u7684\u85e5\u7269\u8b66\u6212\u516c\u53f8\u958b\u59cb\u5f15\u9032\u5927\u8cc7\u6599\u5206\u6790\uff0c\u904b\u7528\u81ea\u52d5\u5316\u7cbe\u5bc6\u5206\u6790\u8207\u8a8d\u77e5\u6280\u8853\u6574\u5408\u4e0d\u540c\u85e5\u7269\u8b66\u6212\u8cc7\u6599\u5eab\uff0c\u4ee5\u53ca\u975e\u7cfb\u7d71\u5316\u8cc7\u8a0a\u3002\u5982\u6cd5\u898f\u3001\u91ab\u7642\u7d93\u6fdf\u3001\u793e\u4ea4\u5a92\u9ad4\u3001\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\uff0c\u8b93\u4e0b\u4e00\u4ee3\u85e5\u7269\u8b66\u6212\u4e0d\u53ea\u505c\u7559\u5728\u5448\u5831\u8207\u8ffd\u8e64\uff0c\u800c\u4e14\u80fd\u5920\u9032\u5316\u6210\u80fd\u9810\u6e2c\u3001\u9810\u9632\uff0c\u4e14\u52a0\u901f\u6700\u4f73\u85e5\u7269\u7be9\u9078\u7684\u6d41\u7a0b\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u6839\u64da\u4e16\u754c\u885b\u751f\u7d44\u7e54\uff08WHO\uff09\u7684\u5b9a\u7fa9\uff0c\u85e5\u7269\u8b66\u6212\uff08Pharmacovigilance\uff09\u662f\u6307\u70ba\u300c\u5075\u6e2c\u3001\u8a55\u4f30\u3001\u77ad\u89e3\u4ee5\u53ca\u9810\u9632\u85e5\u7269\u4e0d\u826f\u53cd\u61c9\u4ee5\u53ca\u4efb\u4f55\u5176\u4ed6\u8207\u85e5\u7269\u6709\u95dc\u554f\u984c\u7684\u6d3b\u52d5\u53ca\u79d1\u5b78\u3002\u300d\u85e5\u7269\u8b66\u6212\u662f 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