As the South African Health Products Regulatory Authority (SAHPRA) embarks on the journey outlined in our Strategic Plan for 2025–2030, it is imperative to reaffirm our commitment to ensuring access to safe, effective, and high-quality health products. Guided by our reinforced vision— an agile and...
As the South African Health Products Regulatory Authority (SAHPRA) embarks on the journey outlined in our Annual Performance Plan for 2025–2026, it is imperative to reaffirm our commitment to ensuring access to safe, effective, and high-quality health products. Guided by our reinforced vision— An agile...
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 101 of 1965, as amended, which provide for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered and medical devices, including...
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,...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Ranbaxy Pharmaceuticals (Pty) Ltd South Africa, Zydus Healthcare SA (Pty) Ltd and, Trinity Pharma (Pty) Ltd wish to inform you about the risk of neurodevelopmental disorders in the children born to women exposed to...
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...
This communication is issued given the current uncertainty about US government funding for healthcare in South Africa, particularly in clinical research, and it intends to emphasise the responsibilities of various stakeholders in Clinical Trials....
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 Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located...
SAHPRA intends to declare medicines compounded in terms of Section 14(4) of the Medicines Act containing Glucagon-Like Peptide-1 (GLP-1) Active Components or a combination of Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide agonist (GIP) Active Components undesirable in terms of Section 23 of the Medicines...