Normal submission of Type IA & IAIN, IB, II The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows: Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a...
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 communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies. It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt....
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,...