新版药物临床试验登记与信息公示平台主要变化及填写注意事项

Major changes of the updated system of drug clinical trials information registry and publication and some key points for registration

本文旨在根据近期药物临床试验登记与信息公示的法规要求变化,对新版登记平台系统的主要功能变化进行介绍;同时,根据信息审核时发现的共性问题、申请人咨询的普遍问题以及登记信息时需注意的重要事项进行说明,其主要目的是在改进登记平台系统易用性和便捷性的同时,逐步提高登记信息的准确性、合规性以及审核和公示效率,及时为业界、公众提供准确、具有参考价值的药物临床试验信息,辅助药物研发。

Based on the new laws and regulations regarding to drug clinical trials information registry and publication,this article is going to introduce the major changes of the updated system for clinical trials information registration.Meanwhile,some common issues during information review,frequently asked questions from applicants and key points for information registration are summarized and highlighted,which of aim is to gradually improve the accuracy and compliance of the clinical trials information,improve the efficiency of information review and publication and provide more accurate and valuable clinical trials information in time for the industry and public in facilitating drug development besides improving the accessibility and convenience for use of the system.