The electronic Common Technical Document (eCTD) 4.0 is an upgraded standard for electronic drug application submissions, offering flexibility, transparency, and improved data quality. However, it also presents challenges such as increased complexity and cost. Pharmaceutical organizations planning to submit applications in the US, Japan, or Switzerland should start preparing for eCTD 4.0 to ensure compliance and timely submissions.
Here we provide a complete report that outlines the latest guidelines and timelines specific to each Regulatory Authority of mentioned countries.