pdf Archives - Page 8 of 45

01 Apr SAHPRA Engagement Portal – Application IDs

Posted at 10:11h in

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,...

31 Mar Topiramate – Risk of Neurodevelopmental Disorders

Posted at 15:34h in

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...

12 Mar Regulatory Information Management System – Cancellation of Health Product Registrations for non-eCTDs

Posted at 09:37h in

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...

10 Mar Clinical Trials Conduct – USA Government Funding Pause/stop

Posted at 10:33h in

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....

10 Mar Comm Issue No.PEM01-CEM01-2025 – Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)

Posted at 09:27h in

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...

10 Mar Communication to Industry – Intention to Declare Medicines Compounded in terms of Section 14(4) Containing GLP-1or GLP-1/GIP Agonists Undesirable

Posted at 08:32h in

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...

03 Mar The Economic Impact of Reliance on an African Medicines Regulatory Authority

Posted at 11:01h in

Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on prior work by trusted regulators. This research aimed at determining the economic impact of reliance on...

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...

27 Feb The Risk of Meningioma Associated With the Use of Medroxyprogesterone Acetate

Posted at 08:39h in

Pfizer and Viatris Healthcare South Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the increased risk of meningioma associated with prolonged use....

25 Feb An Extension to the Exemption of medical Devices and In-Vitro Diagnostics (IVDs) from the provisions of Section 18A and Section 18B of the Medicines and Related substance , 1965(ACT No 101 of 1965 )

Posted at 11:38h in

Government Gazette for Class A medical devices and in vitro diagnostic exemption from section of Section 22C(1) of the medicines and related substance Act 101 of 1965....

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