When a health product is first registered and made available in South Africa, information about its safety and effectiveness is usually only available from clinical trials. Clinical trials provide information about many of the possible adverse events associated with a health product, but do not detect all possible adverse events because they:
- usually do not continue for long enough to detect adverse events that take a long time to develop,
- do not include enough patients to detect adverse events that occur rarely and
- do not include all of the different types of people who might eventually use the product and who might be more vulnerable to some adverse events, such as older people, children, pregnant women or people with other medical conditions.
SAHPRA, like other Regulatory Agencies around the world, monitors the safety of health products to contribute to a better understanding of their possible adverse events when they are used outside the controlled conditions of clinical trials. Reports by consumers and healthcare professionals provide important information for SAHPRA’s safety monitoring program.
An adverse event could be as a result of incorrect user, interaction or other circumstances such as two properly functioning devices that do not operate as intended when used in combination. The occurrence of an adverse event does not necessarily mean that there is something wrong with the health product. Everyone can play an important role in monitoring the safety of health products in South Africa by reporting suspected adverse events to SAHPRA. To report and Adverse Drug Reaction, access our ADR reporting systems here.