Archive

27 Feb Implementation of the Regulatory Information Management System– Status updates on the SAHPRA Engagement Portal

Posted at 09:48h in

Reference is made to HPA15-2024/25, version 5 and version 6. This document serves to inform applicants about the upcoming launch of the SAHPRA Engagement Portal on 01 April 2025. SAHPRA wishes to thank applicants for the validation of data points and to re-iterate the significance of the...

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19 Feb Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration

Posted at 14:12h in

This document is intended to provide clarification on the fees payable in terms of the Medicines and Related Substances Act, 101 of 1965, that have been gazetted on 12 February 2025 for applications for the renewal of the certificate of registration....

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30 Jan Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix

Posted at 09:28h in

This document is intended to provide an update on the document matrix to be utilised by all applicants submitting applications for the Renewal of the certificate of registration from 22 January 2025. The Document Matrix location is as follows: https://ectd.sahpra.org.za/   Reference is made to ZA-SAHPRA eCTD...

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22 Jan Regulatory Information Management System – Application Withdrawal

Posted at 11:40h in

This communication is intended to provide an update to applicants on the process for the cancellation of registered health products in Specification 3.1 and as of 01 November 2024. Reference is made to ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information, July 2024,...

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07 Nov SAHPRA Engagement Portal

Posted at 14:22h in

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....

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29 Oct Implementation of Regulatory Information Management System – Information on eCTD 3.1 Module 1 – Document Matrix

Posted at 10:08h in

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....

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25 Oct Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1

Posted at 15:07h in

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....

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20 Aug Sameness Declaration Form for Reliance-based Models

Posted at 16:24h in

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09 Jul Communication to Industry – Implementation of the Regulatory Information Management System, Version 5 Portal & Interim DVP use

Posted at 11:58h in

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...

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06 Jun ZA-SAHPRA CTD eSubmission Specification – Document for comment

Posted at 20:25h in

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...

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