South Africa SAHPRA Guideline on Post-Marketing Reporting of Adverse Drug Reactions

Sharan Murugan
2 minutes ago
3 min read

The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline on Post-Marketing Reporting of Adverse Drug Reactions (ADRs) to Human Medicine to guide Applicants and Holders of Certificates of Registration (HCRs) on the collection, management and reporting of safety information after registration. The guideline covers ADRs, Adverse Events Following Immunisation (AEFIs) and relevant safety information associated with human medicines, including biological medicines and vaccines.

Purpose of the Guideline

Post-marketing ADR and AEFI reporting supports the identification of previously unrecognised, rare or serious safety concerns associated with medicines. Applicants and HCRs are responsible for reporting relevant safety information to SAHPRA and maintaining appropriate pharmacovigilance activities.

The information submitted may support regulatory action, including changes to product information, restrictions on use or other measures relating to the safety of a medicine.

Pharmacovigilance Responsibilities

Applicants and HCRs should maintain an effective pharmacovigilance system covering the collection, processing, management, follow-up, evaluation and electronic submission of individual case safety reports.

The system should also support safety signal management, continuous safety monitoring, benefit-risk evaluation, risk management activities and preparation of periodic safety reports.

Where pharmacovigilance activities are outsourced, the Applicant or HCR remains responsible for ensuring that appropriate quality systems and oversight are maintained.

ADR and AEFI Reporting Timeframes

For cases occurring in South Africa, serious suspected ADRs and AEFIs must be reported to SAHPRA within 15 calendar days of receipt of the information.

Non-serious suspected ADRs and AEFIs must be reported within 30 calendar days.

For significant safety information that may affect the benefit-risk profile of a medicine, including important safety issues or certain regulatory actions, the applicable reporting timeframe is 5 calendar days from receipt or identification of the information.

Submitting Individual Case Safety Reports

ADR reports should be submitted electronically through the Industry eReporting VigiFlow portal or using the E2B XML format, as applicable. Only one submission method should be used for an individual case safety report.

Applicants and HCRs should provide all relevant information available at the time of the initial report, rather than limiting the submission to the minimum information required. Relevant clinical information, laboratory data and other supporting documentation may also be included.

The original description provided by the initial reporter should be retained, while information received later should be submitted as a follow-up report.

Follow-Up Reports

Initial safety reports may be incomplete, so reasonable efforts should be made to obtain additional information needed for scientific evaluation. Follow-up is particularly important for cases involving special-interest events, pregnancy, patient death, new risks or changes in known risks.

When significant new information is received for a previously submitted case, the reporting clock starts again from the date the relevant follow-up information is received.

Safety Information from the Internet

Applicants and HCRs should regularly screen websites and social media accounts under their management or responsibility for potential ADR and AEFI reports.

Valid unsolicited cases identified online should be handled as spontaneous reports, using the same reportability criteria applied to reports received through other sources. Screening should be sufficiently frequent to allow valid cases to be reported within the applicable timeframe.

Medicine Defects and Interactions

When an adverse event is suspected to be associated with a medicine defect, it should be reported in the same manner as a suspected adverse reaction. The lot number should be included, together with information on quality testing and any corrective actions taken.

Adverse events suspected to result from an interaction between two or more medicines should also be reported as adverse reactions through the prescribed process.

Periodic Safety Reports

Applicants and HCRs should prepare PSURs/PBRERs according to the applicable frequency and target dates. Where no specific frequency has been prescribed and the medicine does not appear on the EURD list, the guideline indicates that these reports should generally be prepared annually.

A South African national appendix should also be prepared annually and include patient exposure in South Africa, ADRs and AEFIs reported in South Africa, and the approved local professional information.

PSURs/PBRERs and the national appendix should be maintained and submitted to SAHPRA when required, including when requested by the Authority or when submission is a condition of registration.

Responsibilities After Suspension or Withdrawal

Pharmacovigilance responsibilities continue even after a medicine is suspended, cancelled or withdrawn. Applicants and HCRs should continue collecting and reporting relevant ADR and AEFI information until six months after the expiry of the last marketed batch.

After this period, new follow-up information relating to previously reported cases should still be reported, while new safety information should continue to be collected for evaluation of delayed-onset reactions and retrospectively reported cases.

For Regulatory Affairs and Pharmacovigilance teams, timely case management, accurate reporting, safety monitoring, and ongoing benefit-risk evaluation are essential for maintaining compliance with South African post-marketing safety requirements.