UM E-Theses Collection (澳門大學電子學位論文庫)
English Abstract
1961, "thalidomide" event facilitated the establishment of the post-marketing drug safety supervision system of the whole world. After more than half a century of development, post-marketing drug safety supervision system in Europe and America and other developed countries has gradually matured, and it has a very important position and role in ensuring drug safety for the people. Since the post-marketing drug safety supervision in Chinese mainland started relatively late, the supervision mechanism is far from Perfect and the construction of the Laws and regulations system as well as others still have many problems. Therefore, it is necessary to continue to learn and draw lessons from the advanced post-marketing drug safety supervision system of work experience on the basis of some now, in order to provide a basis for further perfecting the post-marketing drug safety supervision system of Chinese mainland. Based on the literature and typical cases at home and abroad as the main reference, this paper combs the evolution process of post-market drug safety supervision system, and expounds the theory of the research content of post-market drug safety supervision. Through literature, the official website, from the organization, regulation system and the regulatory process of the post-market drug safety supervision system of the United States and Taiwan to start, this paper summed up the experiences and Revelations of the post-marketing drug safety supervision. Comparing with the United States and Taiwan, mainland China's post-market drug safety supervision system still has many deficiencies. We need to adopt the hierarchical vertical management model to adjust the management system of this supervision system; formulate "post-market drug safety supervision norms" and series of guidelines, as well as laws and regulations of drug relief to improve the existing legal system; broaden the drug safety information collection channels, expand the scope of information collection and establish health and safety database; build a multidisciplinary drug safety review expert team, and at the same time, set up specialized agencies and funds for the research of drug safety re-evaluation methods and techniques; build drug safety information communication platform and formulate the guidance of public communication of drug safety information; develop the traditional Chinese medicine adverse reaction / event reporting rules and regulations, and research it’s evaluation methods and techniques; set up supervision checking system of adverse drug reactions reports and formulate relevant guidance; establish post-market drug safety re-evaluation charging mechanism v and authorize part of the regulatory functions to industry associations and other social institutions. It is hopefully that through the study and discussion of this paper, to provide useful reference for policy makers, researchers and medical professionals of mainland China. Key Words: post-marketing drug; safety; surveillance system; comparative study
Chinese Abstract
1961 年“反應停”事件推動了全球上市後藥品安全監管體系的建立,經過半個 多世紀的發展,歐美等發達國家的上市後藥品安全監管體系已日臻完善。上市 後藥品安全監管在保證民眾用藥安全方面具有非常重要的地位和作用。我國大 陸上市後藥品安全監管工作起步較晚,監管機制還不夠健全,法規體系建設等 方面還存在諸多不足。因此,有必要在現在有的基礎上繼續學習和借鑒先進的 上市後藥品安全監管體系的工作經驗,為進一步完善我國大陆的上市後藥品安 全監管體系建設提供依據。 本文以國內外的文獻資料和典型案例為主要參考,梳理了上市後藥品安全監管 體系的演變歷程,闡述了上市後藥品安全監管的理論研究內容;通過文獻、官 方網站,從美國和臺灣上市後藥品安全監管體系的組織機構、法規體系和監管 流程入手,歸納出其上市後藥品安全監管的經驗和啟示。 對比美國和臺灣地區,中國大陸的上市後藥品安全監管體系還存在很多不足, 需調整組織體系管理體制,採用分層垂直管理模式;健全現有法規體系,制定 《上市後藥品安全監管規範》及其指南等系列文件,確立藥害救濟法規制度; 拓寬藥品安全信息收集渠道,擴大信息收集範圍,建立健康安全資料數據庫; 組建多學科藥品安全審評專家隊伍,設立專門的機構和基金進行藥品安全再評 價方法和技術的研究;建立藥品安全信息溝通交流平臺,制定藥品安全信息公 眾溝通指南;制定中藥不良反應/事件報告的法規和制度,研究評價方法和評價 技術;建立藥品不良反應報告監督檢查制度,制定相關操作指南;建立上市後 藥品安全再評價收費機制,將部分監管職能授權給行業協會等社會機構。希望 通過本文的研究與探討,能為我國大陸的藥品安全法制化建設的決策者、科研 人員及醫藥界人士提供一些有益的參考。 關鍵字:上市後藥品; 安全; 監管體系; 比較研究
Issue Date
Institute of Chinese Medical Sciences
Drugs -- Quality control
藥物 -- 品質控制
Pharmaceutical industry -- Quality control
藥業 -- 品質控制
Pharmaceutical industry -- China -- Quality control
藥業 -- 中國 -- 品質控制
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