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.

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.

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