The aim of the article was to study the difficulties that Chinese drug manufacturing enterprise (hereinafter referred to as drug enterprise) may face after the official implementation of electronic common technical document (eCTD), and to propose countermeasures. The origination, development and global implementation of eCTD were introduced, as well as the relevant guidelines issued by NMPA, so as to analyze the possible problems in the process of eCTD registration application of drug enterprise in China and put forward relative countermeasures. eCTD has been widely used in the world. The eCTD guidelines published in China was established based on V3.2.2 version issued by ICH. eCTD helps to improve the efficiency of drug application but is difficult to develop and has high professional requirements. It is advisable for drug enterprise to make early planning, complete the construction of eCTD registration application system as soon as possible, and prepare the arrival of the eCTD era with a positive attitude.