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Objective: To study the development process, current situation and specific requirements of drug registration based on e-CTD format in the United States, and to provide some reference for the construction of e-CTD channel for drug registration in China.
Methods: A literature review was used to review the regulatory process of e-CTD implementation in the United States, and the data of e-CTD application and total electronic data application were compared and analyzed. To explore the similarities and differences between the traditional registration declaration format and e-CTD format in terms of organization, data requirements, application process and data review, the specific changes were analyzed.
Results & Conclusion: In the process of e-CTD implementation, the United States improved and optimized the submission process and approval process by constantly issuing technical guidelines and paid attention to the training of technical personnel and protected data security. On the one hand, it is suggested that Chinese regulatory agencies improve the guidelines for drug registration application based on e-CTD format as soon as possible, increase policy support such as priority review and approval, and strengthen e-CTD knowledge training for registration personnel in enterprises and review centers. On the other hand, strengthen e-CTD knowledge training for registered personal of enterprises and agencies, enterprises should change their research and development ideas, carry out the QbD concept, formulate a registration operation team suitable for their own development needs, and actively participate in international drug registration to accumulate experience in order to promote the application of e-CTD in enterprises
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目的： 研究美国基于电子通用技术文件（e-CTD）格式的药品注册申报制度，为我国建设e-CTD药品注册通道提供建议与参考。
方法： 采用文献研究法对美国实施e-CTD的监管历程进行回顾，对美国注册时采用e-CTD申报与采用总电子资料申报的数据进行对比分析。探究传统注册申报格式与e-CTD格式在组织机构、资料要求、申报流程和资料审查几方面的异同，并对发生的具体变化进行分析，总结美国实施该申报制度的阻碍和实践经验。
结果与结论： 美国在e-CTD的实施过程中，通过不断发布技术指南来完善、优化药品注册申报资料提交过程和审批流程，注重培训技术人员和保护资料安全。建议我国药品监管机构在电子申报期间不断积累经验，增加如优先审评审批的政策支持，激励e-CTD的应用；同时加强针对企业和审评中心的注册人员e-CTD的知识培训。企业也应转变研发思路，贯彻QbD理念，制定适合自身发展需求的注册运营团队组建计划，积极参与国际药品注册积累经验，以推进e-CTD在企业内的应用。
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丁慧颖，女，硕士研究生，主要从事药事法规与药物政策研究。E-mail: a17851371071@163.com。
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丁慧颖，女，硕士研究生，主要从事药事法规与药物政策研究。E-mail: a17851371071@163.com。
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