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Pilot Project For Electronic Reporting Of Serious Adverse Events E Reporting For Industry Vigiflow Module

South African Health Products Regulatory AuthorityRef: WITH DOCUMENT NUMBER CT02-2026/27

Official source

Source domain: sahpra.org.za

Collected on 3 August 2026

Always confirm details on the official source before acting.

What this means

This document is a SAHPRA (South African Health Products Regulatory Authority) communication inviting sponsors, applicants, Clinical Research Organisations (CROs), investigators, and Holders of Certificates of Registration (HCRs) to participate in a pilot project. The pilot project is for electronic reporting of Serious Adverse Events using the VigiFlow module (an e-reporting portal) for clinical trials. It includes a downloadable document reference with Document Number CT02-2026/27, Version 1, and a Date Updated of 20/04/2026.

Facts

Reference

WITH DOCUMENT NUMBER CT02-2026/27

Key Takeaways

  • Organisation: SAHPRA
  • Pilot project: electronic reporting of Serious Adverse Events
  • System/module: VigiFlow module (e-reporting portal)
  • Target participants: sponsors, applicants, CROs, investigators, HCRs
  • Document Number: CT02-2026/27
  • Version: 1
  • Date Updated: 20/04/2026
  • Posted date: 03 Aug
  • Posted time: 13:51h
  • Contact: enquiries@sahpra.org.za (general enquiries)
  • South African Health Products Regulatory Authority (SAHPRA)
  • Ntokozo Msiza

Dates

Closing Date

20 April 2026