The purpose of this paper is to investigate the current status of the domestic electronic submission system in relation to the comprehensive lifecycle management of drug registration. We aim to analyze the challenges encountered and propose suggestions for improving China's electronic submission system.

By employing the literature review, this study summarizes and compares the development and current status of the domestic electronic submission system. In light of the actual situation in China, it puts forward targeted suggestions for improvement.

In our country, electronic submisisons are categorized into two forms: electronic common technical document （eCTD） submission and Non-eCTD submission. Currently, we are in a transitional phase where both formats coexist. However, during the implementation process, we still face issues such as non-uniform submission format standards and insufficient capacity of provincial bureaus to receive and review eCTDs. In response to these issues, this paper proposes the following specific measures: ①deepening the reform of eCTD and expanding the implementation range of products. ②Strengthening the effective connection of drug management from market launch to post-market. ③Accelerating the standardization of document submission throughout the entire lifecycle of drugs. Through the implementation of these measures, it is expected to expedite the comprehensive electronic process of drug registration and application in our country, thereby enhancing the efficiency and quality of review and approval.