| 张炜敏,黄清泉,成双红,黄宝斌.2010-2020年有关假劣药认定检验研究进展[J].中国药事,2021,35(8):948-956 |
| 2010-2020年有关假劣药认定检验研究进展 |
| Research Progress on Testing of Counterfeit and Inferior Medicines Based on the Literature from 2010 to 2020 |
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| DOI：10.16153/j.1002-7777.2021.08.013 |
| 中文关键词: 假药 劣药 假劣药 检验 药品检验机构 |
| 英文关键词: counterfeit medicines inferior medicines counterfeit and inferior medicines test drug test institutes |
| 基金项目:国家重点研发计划课题(编号 2018YFC0830802)；中国食品药品检定研究院中青年发展研究基金课题(编号 2020G1) |
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| 中文摘要: |
| 目的：梳理分析假劣药认定检验研究现状和存在的薄弱环节，为下一步完善假劣药认定检验工作及开展相关研究提供参考。方法：采取系统综述的方法，对2010~2020年发表的假药、劣药检验相关文献资料进行综合分析。结果与结论：关于假劣药认定检验的研究报道不多，关于技术方法方面的内容相对较多，制度机制研究相对较少。做好假劣药认定检验工作，除了需要药品检验机构积极开发应用新技术新方法提升假劣药认定检验能力之外，还需要加强制度机制方面的研究，完善假劣药认定检验相关法规制度，明确检验报告在认定假劣药中的法律作用，健全药品检验机构之间的协作及与药监部门、司法机关的衔接机制，共同提升假劣药认定检验的效率和效果。 |
| 英文摘要: |
| Objective: The current research status and existing weaknesses of the identification test of counterfeit and inferior medicines were summarized and analyzed, and to provide references for the next step to improve the work of the identification test of counterfeit and inferior medicines and carry out related research. Methods: The systematic review method was adopted to comprehensively analyze the relevant literatures on the test of counterfeit and inferior medicines published from 2010 to 2020. Results and Conclusion: There are not many research reports on the identification test of counterfeit and inferior medicines, and there are relatively more on technical methods, research on system and mechanism is relatively less. To do a good job in the identification test of counterfeit and inferior medicines, on the one hand, drug test institutes need to actively develop and apply new technologies and methods to enhance the ability of identification test of counterfeit and inferior medicines. On the other hand, it is also necessary to strengthen the research on the system and mechanism. The regulations and systems related to the identification test of counterfeit and inferior medicines should be improved, and the legal role of the test report in the identification test of counterfeit and inferior medicines should be clarified. The cooperation should be improved between drug inspection institutions and the linkage mechanism with drug regulatory departments and judicial organs, so as to jointly promote the efficiency and effect of the identificationand inspection of counterfeit and inferior medicines. |
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