| 丁晓丽,王雪蕾,魏京京,谭丽媛,姚尚辰,王岩,孙会敏.2020-2023年进口化学药品注册检验工作情况分析及思考[J].中国药事,2024,38(7):731-737 |
| 2020-2023年进口化学药品注册检验工作情况分析及思考 |
| Analysis and Reflection on the Situation of Registration and Inspection ofImported Chemical Drugs from 2020 to 2023 |
| 投稿时间：2024-04-08 |
| DOI：10.16153/j.1002-7777.2024.07.001 |
| 中文关键词: 进口化学药品 注册检验 工作程序变化 问题及挑战 总结分析 |
| 英文关键词: imported drug registration and inspection change of work procedure problem and challenge summary and analysis |
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| 中文摘要: |
| 目的：为进一步提高进口化学药品注册检验的工作效率及工作质量提供参考。方法：对2020-2023年药品注册检验工作程序的发展变化、进口化学药品注册检验的工作概况及存在问题等多个方面进行总结分析。结果：随着注册检验工作程序的修订完善，进口化学药品注册检验申报数量呈明显上升趋势，检验技术难度也逐步增加，同时存在申报单位的资料、样品等准备不充分，信息化建设不足等问题。结论：通过总结分析，探讨进口化学药品注册检验工作面临的问题及挑战，建议加强口岸药品检验机构的能力建设及信息化建设，加强申报人员的指导培训工作等，为进一步提高进口化学药品注册检验的工作效率及工作质量提供参考。 |
| 英文摘要: |
| Objective: To provide suggestions for effi ciency and quality of imported chemical drugs registrationand inspection. Methods: The changes of work procedure, general situation and existing problems of importeddrugs registration and inspection from 2020 to 2023 were summarized and analyzed. Results: With the revision ofthe drugs registration and inspection procedure, the quantity and diffi culty of the registration and inspection haveincreased signifi cantly. At the same time, it exists problems such as the insuffi cient preparation of the informationand samples, and the insuffi cient information construction. Conclusion: Through summary and analysis, problemsand challenges of imported chemical drugs registration and inspection were discussed, suggestions were putforward, such as strengthening the capacity building and information construction of the port drugs inspectioninstitutes, strengthening the guidance and training of applicants, etc., to provide references for further improvment of imported drugs registration and inspection. |
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