South Africa's SAPHRA Guideline for Industry e-reporting

Pharmacovigilance plays a critical role in protecting public health by enabling the timely identification, assessment, and management of medicine safety concerns. Accurate reporting of adverse drug reactions (ADRs) and Adverse Events Following Immunisation (AEFIs) allows regulatory authorities to continuously monitor the benefit-risk profile of authorised medicines and implement appropriate regulatory actions when necessary.

To strengthen electronic pharmacovigilance reporting, the South African Health Products Regulatory Authority (SAHPRA) has published the Guideline for Industry eReporting. The guidance introduces a web-based electronic reporting platform that enables Holders of Certificate of Registration (HCRs) and Applicants to submit Individual Case Safety Reports (ICSRs) directly to SAHPRA's National Database using internationally harmonised reporting standards. It also provides detailed instructions for system access, report submission, account management, electronic data transmission, and ongoing pharmacovigilance reporting requirements.

Why This Guidance Is Important

Timely reporting of adverse events is essential for detecting previously unidentified, rare, or serious safety concerns associated with medicines and vaccines. The quality, completeness, and accuracy of submitted safety reports directly influence SAHPRA's ability to evaluate emerging risks, update Professional Information (PI) and Patient Information Leaflets (PILs), implement risk minimisation measures, restrict medicine use where necessary, or withdraw products from the market.

The new Industry eReporting platform modernises pharmacovigilance reporting by replacing paper-based CIOMS submissions and email-based XML reporting with a secure electronic system that supports faster, standardised, and more efficient safety reporting.

Purpose and Scope

The guidance is intended for Holders of Certificate of Registration (HCRs) and Applicants responsible for reporting Individual Case Safety Reports (ICSRs) and Adverse Events Following Immunisation (AEFIs) in South Africa.

Industry eReporting, developed by the Uppsala Monitoring Centre (UMC), allows organisations to submit safety reports either through structured manual data entry based on the ICH E2B(R3) standard or by uploading E2B XML files in both R2 and R3 formats. The guidance applies to adverse event reports received from healthcare professionals, consumers, scientific literature, and other recognised reporting sources.

Legal Requirements

The guidance is issued in accordance with Regulation 40 of the Medicines and Related Substances Act, 1965.

Applicants, Holders of Certificate of Registration, and licence holders are required to report new or existing quality, safety, and effectiveness concerns associated with registered medicines, including adverse drug reactions and related risk management activities. Organisations must also maintain records of submitted reports and supporting documentation to demonstrate ongoing compliance with pharmacovigilance obligations.

Key Features of Industry eReporting

The Industry eReporting platform supports direct electronic transmission of safety reports to SAHPRA's National Database using internationally recognised ICH E2B standards.

Key system capabilities include structured electronic data entry, support for E2B XML uploads, compatibility with MedDRA and WHODrug terminology, attachment of supporting PDF documents, immediate report submission, follow-up reporting, XML acknowledgement (acklog) downloads, and standardised electronic case management. These features improve data quality while facilitating faster regulatory review and international pharmacovigilance harmonisation.

Technical Requirements and Account Setup

Before using the system, organisations should ensure reliable internet connectivity, updated web browsers, secure password management, and appropriate protection of user credentials.

Access to Industry eReporting is granted by SAHPRA upon request. Organisations may register up to three corporate user accounts and must provide company identification details, sender identifiers, organisation information, and authorised user details. First-time users generate passwords through a secure email verification process before accessing the platform.

MedDRA and WHODrug Integration

To support standardised pharmacovigilance coding, the platform integrates both MedDRA and WHODrug.

Users must validate their MedDRA licence using an API key and activate their WHODrug licence before these coding dictionaries become available within the reporting interface. Once activated, users can search standardised medical terminology during report preparation, improving consistency in adverse event coding and facilitating international data exchange.

Report Submission and Case Management

Industry eReporting provides two methods for submitting reports: manual data entry and E2B XML file upload.

Manual reporting allows users to create new reports, edit draft reports, submit follow-up reports, and nullify previously created reports. Organisations with validated safety databases may alternatively upload XML files compliant with the ICH E2B standard.

For follow-up reporting, users upload the previously submitted XML file, update new safety information, revise the case narrative, and resubmit the report. The guidance specifically advises against using acknowledgement (acklog) files for follow-up submissions because they are intended solely to confirm successful transmission.

Acknowledgement Files and Submission Verification

Following every submission, users should verify successful transmission by reviewing both the submission status and the acknowledgement (acklog) file.

The guidance explains that a "Completed" submission status confirms successful transmission from the Industry eReporting platform but does not guarantee that reports have been accepted into SAHPRA's regulatory database. Organisations should therefore review the acklog to confirm successful processing and retain downloaded acknowledgement files as part of their pharmacovigilance records.

Adhering to these requirements enables Holders of Certificate of Registration and Applicants to fulfil their pharmacovigilance obligations while contributing to improved patient safety and more effective post-marketing monitoring of medicines.

References

• For Detailed information, refer to SAHPRA: Guideline for Industry eReporting