The South African Health Products Regulatory Authority (SAHPRA) has issued important updates impacting the technical files located in the SAHPRA eCTD repository and found in the following location, SAHPRA eCTD....
The South African Health Products Regulatory Authority (SAHPRA) provides the following key updates on the SAHPRA Engagement Portal....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The South African Health Products Regulatory Authority (SAHPRA) announces urgent webinars scheduled for Monday, 07 April 2025, Wednesday, 09 April 2025 and Friday, 11 April 2025 from 14:00-16:00....
The South African Health Products Regulatory Authority (SAHPRA) Engagement Portal launched on 01 April 2025. We thank applicants for embracing the new system, quickly adapting to it, and promptly bringing to our attention any challenges encountered. This communication seeks to resolve a frequently encountered challenge...
Applicants are hereby notified that the South African Health Products Regulatory Authority (SAHPRA) Engagement Portal is set to launch at midday on 01 April 2025....
This communication serves to notify applicants about the issuance of Application IDs. Following the administrative freeze (ending 31 March 2025), newly generated Application IDs will be available on the portal for each application, encompassing all strengths and multiples combined. In accordance with eCTD Specification 3.1,...
This communication aims to provide an update to applicants regarding a South African Health Products Regulatory Authority (SAHPRA)-initiated grace period for cancelling the registration of health products not in eCTD format. Post the implementation of the eCTD 3.1 submissions process, SAHPRA has started to receive communication...
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...