Communication to industry Archives

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...

04 Jun Pilot: Clinical Trial Applications Electronic System – Update

Posted at 09:50h in

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....

01 Jun Regulatory Requirements for Medical Devices Electronic Instructions for Use (e-IFU)

Posted at 10:44h in

The Medicines and Related Substances Act No. 101 of 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 09 December 2016, provides for the regulatory oversight on labelling of...

15 May SAHPRA Warning About Unregistered Peptide Products: What You Need to Know and How To Stay Safe

Posted at 14:51h in

SAHPRA is seeing an increase in unregistered peptide products being sold online, in gyms, and through informal channels. Because these products have not been evaluated and approved by SAHPRA for safety, quality, or efficacy, they can seriously harm your health. If you are unsure about...

07 May Bioequivalence studies performed by Contract Research Organisation (Raptim Research Pvt. Ltd)

Posted at 18:49h 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 Raptim Research Pvt. Ltd, a Contract Research Organisation...

Archive