The New SAHPRA eCTD site can be accessed via SAHPRA website.
The new specifications, guidelines and validation criteria is effective 1 October 2024 allowing adequate time for implementation – the only requirement we have now that is applicable post the HPA admin freeze is the new trigger XML file – which we will discussing a bit later on..
Website url: https://ectd.sahpra.org.za/ The gateway to the Portal and eCTD Information.
The website will not only include eCTD information, but will also be publishing eSubmission Specifications and Guidance here. eCTD is the end goal for any CTD based application, so we feel it is appropriate to refer to it as our eCTD Website.
For Complete File do visit : https://www.linkedin.com/posts/nr-pharmreg-submission_south-african-ectd-30-launch-activity-7179735704543895552-4kfg?utm_source=share&utm_medium=member_desktop