This communication serves as a formal update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine‑containing medicines following the consultative meeting held on 24 April 2026 and subsequent internal deliberations by the Authority....
The South African Health Products Regulatory Authority (SAHPRA) invites all Holders of Certificates of Registration (HCRs) and Clinical Research Organisations (CROs) responsible for submitting adverse events (AEs) and/ or serious adverse events (SAEs) to a consultation meeting on the implementation of the Industry e-Reporting VigiFlow...
SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is in progress for new medicinal clinical trial applications from April 2026 and so far included May and June 2026 submission due dates....
This guideline is intended to provide guidance to applicants who intend to submit extension applications for registration. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current position on the safety, quality and efficacy of these medicines. ...
This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all Applicants/ Holders of Certificates of Registration (HCRs) who intend to submit/ have submitted applications supported by bioequivalence studies conducted by Raptim Research Pvt. Ltd, a Contract Research Organisation...
The South African Health Products Regulatory Authority hereby issues an update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines, following the communication dated 23 March 2026. Download previous version ...
This document is intended to provide communication to various stakeholders conducting Clinical Trials on allowed method for Serious Aderse Events (SAE) reporting to SAHPRA....
The applicant is to ensure that all relevant fields are completed on the application form and that all supporting documentation is attached. Incomplete applications will be identified as deficient, and the evaluation review will not be progressed until deficiencies are addressed. A completed application...
This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...
This document has been prepared to serve as a guideline for the preparation of applications to conduct first-in-human (FIH) and Phase I clinical trials in South Africa. It is not intended as an exclusive approach, and SAHPRA reserves the right to request any additional information...