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South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction

The South African Health Products Regulatory Authority (SAPHRA) did a few Administrative updates and amendments in its Post-marketing Reporting of ADRs guidance this week.

“Adverse drug reaction” or “adverse reaction” means a response to medicine in humans that is noxious and unintended, including lack of efficacy, and which occurs at doses normally used in man, and which can also result from an overdose, misuse, or abuse of medicine.

Reporting of ADRs/AEFIs and monitoring is a viable means of identifying previously unrecognized, rare or serious ADRs/AEFIs.

This guidance document covers the collection of Adverse Drug Reactions (ADRs), Adverse Event Following Immunisation (AEFIs) and product quality issues by SAHPRA for the following registered and marketed health products:

• Medicines for use by humans, including biological medicines and vaccines (Category A)

• Complementary medicines for use by humans (Category D).

• Radiopharmaceuticals, including radionuclides.

This guideline is intended to assist applicants/HCRs in the reporting of ADRs/AEFIs associated with the use of registered medicines and “Old Medicines” and in the management of safety data which may arise during post-registration, including during Phase 4 post-marketing clinical trials.

Click this LINK to know in detail about this guidance.


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