The South African Health Products Regulatory Authority (SAHPRA), have reviewed the Post Marketing Reporting of ADR guideline following concerns raised by the industry on version 7 of the guideline published September 2020. In addition to the review, SAHPRA conducted a webinar with holders of...

This document has been prepared to serve as a guideline to healthcare professionals reporting adverse drug reactions, adverse event following immunisations and product quality problems. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines.