SAHPRA maintains a dedicated pharmacovigilance guidance set covering company PV systems, adverse-reaction reporting, risk management, inspections and electronic reporting.
Core official resources
- Pharmacovigilance Guidelines — central directory of current SAHPRA PV guidance.
- Post-marketing reporting of adverse drug reactions — current holder/applicant reporting guidance.
- Guideline for Industry e-reporting — current electronic reporting guidance.
- Health Products Vigilance — public and healthcare-professional reporting information and e-reporting routes.
Practical use
SAHPRA updates individual PV guidelines independently. Check the version and date of each document rather than relying on a static internal procedure. As of September 2026, the post-marketing ADR reporting guideline is version 11 and the industry e-reporting guideline is version 1.