As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we have launched the SAHPRA Engagement Portal on Monday, 04 November 2024. The first phase of the phased roll-out is to have all users start the User Account creation process....
This document is intended to provide an update on the document matrix to be utilised by all applicants from 01 November 2024 (eCTD 3.1 go-live date). The Document Matrix location is as follows: ectd.sahpra.org.za....
This document is intended to provide an update on the progress for the Regulatory Information Management System (RIMS) deployment. In the development of the new eCTD specifications, attention has been given to global best practice and the frameworks and specifications from other Recognised Regulatory Authorities....
This document is intended to provide communication to applicants on system updates regarding the Regulatory Information Management System (RIMS) Portal and the Digital Variations Portal (DVP). SAHPRA’s digital transformation has progressed as planned with submissions via the sFTP for new product applications, all variations, and renewals...
The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...
This communication is intended to provide an update on the progress of the Regulatory Information Management System (RIMS) deployment at the South African Health Products Regulatory Authority (SAHPRA)....
To be printed on the letterhead of the Holder of the Certificate of Registration...
To be printed on the letterhead of the proposed Holder of the Certificate of Registration...
During the recent webinar engagements, we have had several applicants raise questions seeking clarity around the appropriate process to follow for submitting Responses to queries that have been shared by SAHPRA for their review, action and response – for either new medicine applications or variation...