The Status of the Electronic Common Technical Documents Implementation in China: A Comparative Study Based on the USA and EU

This paper aims to analyze the problems that China may face in the eCTD implementation process and provide corresponding solutions so as to promote the stable and high-speed development of China's eCTD construction.

This study mainly uses literature research method and comparative analysis method. By searching and analyzing relevant literatures, laws and regulations at home and abroad, this study chooses the USA, the EU and China as objects and makes comparative analysis from three aspects of policy tools, regulatory guidelines and implementation situation among three regions.

As for policy tools, the USA and EU rely on environmental tools, while provide less support for supply-oriented and demandoriented tools. As for regulatory guidelines, the guidelines of the USA are more comprehensive and detailed; while the guidelines of the EU are looser and focus on practice, but both maintain a high updating frequency. As for implementation situation, from recommendation to compulsory implementation, the USA and EU both give up the one-step approach, and the situation is generally good.

The obstacles to the promotion of eCTD in China mainly focus on the implementation status of CTD, the perfection degree of policy system, the level of software construction and the status of professional personnel training. Therefore, government should set up reasonable transition mode, improve the policy system and infrastructure construction, and cultivate professional talents. Enterprises should take an active part in the implementation of eCTD, choose the appropriate way of cooperation with software suppliers, and build internal professional registration teams.