实施eCTD面临的机遇、挑战和对策

Opportunities,challenges and countermeasures for the implementation of eCTD

药品电子通用技术文档(electronic common technical document,eCTD)作为国际通行的药品申报及审评管理方式,有利于规范药品申报资料质量,提高药品研发能力,提升药品审评效率。本文在介绍我国药品审评业务现状的基础上,提出我国实施eCTD的重要性和必要性。结合eCTD技术的主要内容,介绍eCTD的发展历史和主要优势。在分析我国药品审评信息化现状的基础上,总结我国实施eCTD面临的主要挑战。最后,通过分析现有问题,给出我国实施e CTD可采用的主要对策。

The electronic common technical document ( eCTD),as an internationally accepted means of drug application and review management,is conducive to standardization of the quality of application dossiers, improvement of the capacities of drug R&D,and enhancement of the efficiency of drug reviews. Based on the introduction to the actualities of China's drug review practices,this paper proposed the significance and necessity of implementing eCTD in China. The history of the development and the main advantages of eCTD were described by combining the main contents of the eCTD techniques,and the main challenges of implementing eCTD were also summarized by analyzing the actualities of informationized drug review in China. Finally,the main countermeasures for implementing eCTD in China were put forward through the analysis of the existing issues.