Communication to industry Archives

21 Aug Call for Stakeholders to Verify Their Records – Missing Applications for Variations

Posted at 13:51h in

The South African Health Products Regulatory Authority (SAHPRA) calls on industry stakeholders to verify their records and identify any variation applications that may have been submitted but remain unprocessed due to the transition to the new system. The applications that may have been affected were...

13 Aug Guideline for Health Product Traceability: Update on Implementation

Posted at 15:24h in

As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...

12 Aug General Regulations Made in Terms of the Medicines and Related Substances Act 101 of 1965: Amendment to Regulation 6: Notice of Correction

Posted at 11:43h in

The South African Health Products Regulatory Authority (SAHPRA) wishes to inform all pharmaceutical industry stakeholders that an amendment to Regulation 6 was published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026 for implementation. The published amendment contained two aspects: first, the...

11 Aug Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestants

Posted at 09:32h in

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....

03 Aug Pilot Project for Electronic Reporting of Serious Adverse Events (e-Reporting for Industry – VigiFlow Module)

Posted at 13:51h in

The South African Health Products Regulatory Authority (SAHPRA) invites sponsors, applicants, Clinical Research Organisations (CROs), investigators and Holders of Certificates of Registration (HCRs) conducting clinical trials to participate in a pilot project for the electronic reporting of Serious Adverse Events through the VigiFlow module (e-reporting...

28 Jul Pharmacovigilance and Clinical Trials Units | SAHPRA Industry Consultation on e-Reporting VigiFlow Platform

Posted at 12:36h in

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...

23 Jul Contact Details for Guideline No. SAHPGL-MD-03 Medical Device vigilance: Adverse Events Reporting for Licence Holders

Posted at 11:37h in

This document provides contact details for reporting adverse events in accordance with the latest version of Guideline No. SAHPGL-MD-03 accessible on SAHPRA Website, Field Safety Corrective Actions. It also includes contact information for medical devices recalls, including In vitro diagnostics (IVDs)....

14 Jul Extension of Submission Window for Type II Variations Pilot Project

Posted at 13:27h in

The South African Health Products Regulatory Authority (SAHPRA) hereby notifies all applicants and holders of certificates of registration that the submission window for Type II Variations Pilot Project , including related changes bundled variations submissions, has been extended to Friday, 31 July 2026....

25 Jun Communication on Research Use Only (RUO) and Investigational Use Only (IUO) Medical Devices including In Vitro Diagnostic Devices (IVDs)

Posted at 13:46h in

This document is intended to provide communication to stakeholders on the regulatory requirements and classification of Research Use Only (RUO) and Investigational Use Only (IUO) medical devices, including in vitro diagnostics (IVD)....

24 Jun Mandatory call up for holders of certificates of registration to submit post marketing adverse event reports for human medicines (serious and non-serious) through Industry e- Reporting VigiFlow module

Posted at 17:55h in

This document is intended to provide communication to all Holders of Certificates of Registration (HCRs)/ Applicants about the mandatory submission of Post-marketing Adverse Event (AE) reports for human medicines through Industry eReporting VigiFlow module. The submission of post-marketing AE reports for human medicines is applicable...

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