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SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product

South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products.

This guideline pertains to the planning, conducting, reporting and following-up of Pharmacovigilance inspections in South Africa. This guideline is designed to facilitate compliance by the applicants/HCRs and to enhance consistency in the application of the regulatory requirements regarding good pharmacovigilance practices.

South African Health Products Regulatory Authority (SAHPRA) shall conduct pharmacovigilance inspections of applicants/HCRs or any licence holder employed to fulfil the applicant/HCR’s pharmacovigilance requirements to ensure compliance with regulatory pharmacovigilance obligations.

The purpose of this guideline is to provide guidance on areas of inspection for applicants/HCRs and their contractors, to ensure that they:

  • have an adequate and effective quality system for monitoring the medicines in order to protect public health;

  • maintain a pharmacovigilance system master file;

  • 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 Substance Act (Act 101 of 1965) as amended.

The objectives of pharmacovigilance inspections are:

  • to ensure that applicants/HCRs have personnel, systems and facilities in place to meet their pharmacovigilance obligations;

  • to improve the pharmacovigilance system established by applicants/HCRs;

  • to identify, record and address non-compliance which may pose a risk to public health;

  • to use the inspection results as a basis for enforcement action, where considered necessary.

Click this LINK to know more about this guidance.


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