文章摘要
冉薇,张喆.我国药品注册工作实施eCTD的探讨[J].中国药事,2018,32(5):595-598
我国药品注册工作实施eCTD的探讨
Discussion on Implementation of eCTD in Drug Registration in China
投稿时间:2018-01-05  
DOI:10.16153/j.1002-7777.2018.05.004
中文关键词: 药品注册  eCTD  组成  优势  实施情况  挑战  建议
英文关键词: drug registration  eCTD  composition  advantage  implementation  challenge  suggestion
基金项目:
作者单位
冉薇 国家食品药品监督管理总局信息中心, 北京 100053 
张喆 国家食品药品监督管理总局信息中心, 北京 100053 
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中文摘要:
      目的:为我国药品注册工作实施电子通用技术文档(eCTD)提供参考。方法:介绍eCTD的组成、优势和在全球的实施情况,结合我国实情,从政策、技术层面探讨我国实施eCTD面临的挑战。结果与结论:eCTD在药品注册资料的创建、传输、审阅、检索、存档及文件生命周期管理等方面具备的优势,保证了资料的完整、规范,提高了申报、审评效率,节约了注册成本。但在系统安全性、原辅料与药品注册数据关联、中药制剂注册申报等方面仍需进一步完善,并加强相关专业人才的培养,以加快推进eCTD信息化系统建设和使用。
英文摘要:
      Objective:To provide references for implementing the electronic common technical document (eCTD) in drug registration in China. Methods:The composition, advantages and global implementation of eCTD were introduced. Combined with the facts of our country, the challenges of implementing eCTD in China were discussed from the aspect of policy and technology. Results and Conclusion:The advantages of eCTD in creating, transmitting, reviewing, retrieving, archiving document and in document lifecycle management as well, ensure the integrity and standardization of data, improve the effciency of application and review, and save the registration cost. However, the system security, the association between raw materials and drug registration data, registration application of Chinese medicine preparations and other aspects still need further improvement. The training of relevant professionals should be strengthened to speed up the construction and use of eCTD information system.
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