腾讯网

速报 II CDE即将举办药品电子通用技术文档（eCTD）申报宣讲会

为落实《国家药监局关于实施药品电子通用技术文档申报的公告》（2021年第119号）要求，推动药品电子通用技术文档（eCTD）在中国的转化实施，药审中心将组织召开eCTD申报宣讲会，帮助药品注册申请人和软件开发企业等负责药品注册相关人员理解我国eCTD的技术 ...
PMLiVE

eCTD 4.0 is changing the regulatory landscape – what you need to know

All regions that have published guidelines will mandate implementation of eCTD version 4.0 by 2028, with more regions to follow in the future Developed by the International Council for Harmonisation ...