Practical implication
Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.
The South African Health Products Regulatory Authority (SAHPRA) has initiated a consultation that requires all Holders of Certificates of Registration (HCRs) and Clinical Research Organisations (CROs) to transition to the VigiFlow platform for electronic safety reporting. This shift aims to modernize pharmacovigilance practices according to international E2B standards, necessitating updates to current manual reporting processes.
What changed: Introduction of the VigiFlow platform as the mandatory electronic reporting portal for submitting adverse events (AEs) and serious adverse events (SAEs) in South Africa.
Why it matters: This transition to a fully digital reporting platform enhances the efficiency and accuracy of safety data submissions, aligning South Africa with international pharmacovigilance standards.
Practical implication: Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.
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Published from the Firecrawl policy change extraction pipeline.
