| 我国药品上市后重点监测相关问题的探讨 |
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| 引用本文： | 蔡婷,闫磊,刘述森,詹思延.我国药品上市后重点监测相关问题的探讨[J].药物流行病学杂志,2017(5):297-324. |
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| 作者姓名： | 蔡婷 闫磊 刘述森 詹思延 |
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| 作者单位： | ①北京大学公共卫生学院流行病与卫生统计学系（北京 100191）；②默沙东研发（中国）有限公司默克研究院观察性研究中心药物流行病学亚太分部。 |
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| 摘 要： | 摘 要为加强我国药品上市后监管力度，保障药品安全，国家食品药品监督管理总局于2011年正式提出了开展重点监测的要求，并于2013年进一步制定了《生产企业药品重点监测工作指南》（征求意见稿）。该指南对我国药品重点监测这一新制度的含义、内容、责任主体、程序、标准等进行了初步规定，以指导药品生产企业规范开展重点监测工作，保障重点监测制度的顺利实施。重点监测制度目前尚处于起步阶段，各界理解存在差异，通过对指南内容进行解读，对重点监测实施中可能存在的相关问题进行探讨，有助于更好地达到重点监测工作的目的和预期效果。
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| 关 键 词： | 药品安全 药品上市后监测 政策 指南 |
Interpretation of the Drug Post marketing Intensive Surveillance Policy in China |
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| Cai Ting,Yan Lei,Liu Shusen,Zhan Siyan.Interpretation of the Drug Post marketing Intensive Surveillance Policy in China[J].Chinese Journal of Pharmacoepidemiology,2017(5):297-324. |
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| Authors: | Cai Ting Yan Lei Liu Shusen Zhan Siyan |
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| Abstract: | ABSTRACTTo strenghthen the drug post marketing surveillance system and ensure the drug safety, the China Food and Drug Administration (CFDA) introduced a policy of drug post marketing intensive surveillance and its related work guideline in 2013. This guideline regulated the property, content, responsibility, procedure and criterion of the intensive surveillance to direct pharmaceutical companies to carry out the work and implement the policy. Since the policy was on its initial stage and the understanding of the regulation was discrepant, learning about the content of the guideline and discussing the potential problems could be helpful to achieve the objective and expectation of the intensive surveillance. |
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| Keywords: | Drug safety Drug post marketing surveillance Policy Guideline |
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