The aim of this newsletter is to disseminate regulatory information on post-marketing surveillance and pharmacovigilance activities rendered by SAHPRA, which includes responsibilities of the SAHPRA Pharmacovigilance unit, reporting tools and pharmacovigilance systems in the country....
This manual is guided by the policies of the NDoH and SAHPRA, with recommendations from the World Health Organization (WHO), to serve as guidelines for vaccine safety surveillance. It provides guidelines and procedures to healthcare professionals at all levels within the healthcare sector in South Africa in the...
The SAHPRA Pharmacovigilance Reference Manual for Healthcare Professionals in South Africa, used in tandem with the Training Manual for Healthcare Professionals on Pharmacovigilance in South Africa, will facilitate the early detection of health product-related adverse reactions and enable the identification of previously unknown adverse drug...
SAHPRA has developed this manual to facilitate training of HCPs in pharmacovigilance. We hope that this training manual will effectively prepare the facilitators to train other HCPs in the science of pharmacovigilance....
This handbook serves as a resource for the detection and reporting of adverse events (AEs) associated with health products used in South Africa. It is intended to serve as an easy reference tool to promote understanding of pharmacovigilance and encourage HCPs to actively participate in...
This document is intended to provide communication to industry and guide stakeholders on how to prepare and distribute “Dear Veterinary Professional” (DVP) letters for safety concerns associated with the use of registered veterinary medicines. It gives details on the format and content to effectively communicate...
The National Immunisation Safety Expert Committee (NISEC), formerly a National Department of Health (NDoH) Ministerial Advisory Committee on vaccine safety, now serves as a Technical Advisory Committee within the South African Health Products Regulatory Authority (SAHPRA). This transition integrates NISEC's specialised vaccine-safety expertise into SAHPRA’s...
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...
This document serves as a guideline for those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The Authority reserves the right to request any additional information to establish the...
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...