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South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems

Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on "Pharmacovigilance Systems".


A pharmacovigilance system consists of specific pharmacovigilance processes that are purposed to ensure good pharmacovigilance practice.

A pharmacovigilance system is a system used by applicants/Holder of Certificate of Registration to fulfill their legal mandate and responsibilities in relation to pharmacovigilance and is designed to monitor the safety of all registered health products and detect any change to their risk-benefit balance.


This is to ensure that evidence of adverse events, interactions, and information regarding post-market surveillance and vigilance is monitored, analyzed and responded to in a functional pharmacovigilance system operated by the HCR.


The purpose of this guidance is to facilitate compliance by HCRs and to enhance consistency in the application of regulatory requirements governing good pharmacovigilance practices.


The guidelines provide an overview of all aspects of a quality-assured pharmacovigilance system, including risk management. They provide guidance as to what is expected of holders of certificates of registration in relation to pharmacovigilance systems.

  • Have an adequate and effective pharmacovigilance system and its quality system for monitoring the medicines that are registered in order to protect public health

  • maintain a pharmacovigilance system master file (PSMF)

  • have adequate, competent, appropriately qualified and trained staff to work on the pharmacovigilance system

  • comply with the pharmacovigilance obligations as per the Medicines and Related Substances Act

Click this LINK to know more about the qualifications of QPPV etc.

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