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Pharmacovigilance Requirements in South Africa

In South Africa, the pharmacovigilance system is mature and regulated by the South African Health Products Regulatory Authority (SAHPRA). It is ICH-aligned and serves as a benchmark for the region, enforcing strict post-marketing and clinical safety requirements.

1. Clinical Safety (Clinical Trials)

Clinical trials require SAHPRA approval and adherence to ICH GCP guidelines.

  • Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs).

    • Fatal or Life-Threatening: Within 7 calendar days.

    • Other Serious Unexpected: Within 15 calendar days.

  • Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.

  • Submission: Reports are submitted via SAHPRA channels (electronic/forms).

2. Post-Marketing Pharmacovigilance

  • Personnel & Infrastructure:

    • Local QPPV: Mandatory. A qualified person (pharmacist/physician) resident in South Africa must be appointed as the primary contact.

    • PSMF: Required. A Pharmacovigilance System Master File must be maintained and available for SAHPRA inspections.

  • Incident Reporting (ICSRs):

    • Timelines:

      • Serious: Within 15 calendar days.

      • Non-Serious: Within 90 calendar days.

  • Risk & Periodic Reporting:

    • PSURs: Mandatory (Frequency: typically every 6 months for the first 2 years, then annually).

    • RMPs: Mandatory for new chemical entities, biologics, and high-risk products (EU format with local annex).

Summary of Requirements

Component Requirement in South Africa
Regulatory Authority SAHPRA (South African Health Products Regulatory Authority)
Framework Medicines Act 1965 / ICH Aligned
Local QPPV / PSMF Yes (Local QPPV) / Yes
Safety Reporting 15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting SUSARs (7/15 days)
Submission Language English

How to report?

Physical Address:

Loftus Park Building A (2rd FLOOR)

402 Kirkness Road,

Arcadia Pretoria

South Africa

E-Mail:

 

 

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Is local QPPV mandatory in South Africa?

Yes; every MAH needs to nominate a local Pharmacovigilance Officer in South Africa.

"Responsibilities of the holder’s or applicant’s pharmacovigilance officer should include:

(i) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions, which are reported to the holder or applicant, including to medical representatives and clinical research associates, is collected and collated so that it is accessible at a single point;

(ii) serving as a contact person for the Authority and NADEMC for all matters relating to pharmacovigilance;

(iii) the preparation of the following, either directly or by delegation/supervision, for submission to the authority: - ADR reports; - summary report for both serious and non-serious ADRs occurring in South Africa; - Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRER), when necessary; - company-sponsored post-registration study reports, when required; and - ongoing pharmacovigilance evaluation during the post-registration period; and

(iv) ensuring that any request from the Authority for additional information deemed necessary for the evaluation of the risk-benefit ratio of medicine, is provided to the Authoritypromptly and in accordance with all requirements,

(v) ensure that all the above responsibilities are met for all old and registered medicines on the Authority's Register that is marketed in South Africa. For products that are no longer marketed, post-marketing surveillance and reporting of ADRs should continue until six months after the expiry date of the last marketed batch."

Reporting safety and quality concerns

Consumers: If you are concerned that you have had an adverse effect/side effect to a medicine, or experienced a quality problem with any type of health product regulated by SAHPRA, you may need to contact your healthcare professional (a nurse, pharmacist, doctor etc) who can advise on any treatment that may be needed. They can also report the issue to SAHPRA on your behalf. Should you wish to report an adverse event by yourself, kindly click here. to access the e-reporting portal. Alternatively, click here to download an adverse drug reaction form and email it to adr@sahpra.org.za. Before completing the form kindly ensure that you first read “information regarding reporting of an adverse event” above to ensure that you provide the information required.

 

Healthcare Professionals: If you wish to report an adverse event or quality issue relating to the use of a health product, kindly click here  to access the e-reporting portal. Alternatively click here to download an ADR reporting form and email it to: adr@sahpra.org.za, or use the Adverse Event Following Immunisation (AEFI) reporting form in case of a vaccine related issue.

Pharmacovigilance Systems - PSMF, QPPV, Training, etc

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RMP Requirements

 

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GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRs) REPORTING FOR HEALTHCARE PROFESSIONALS

PHARMACOVIGILANCE PROCESS OF ISSUING SAFETY RECOMMENDATIONS TO APPLICANTS/HCRS FOR IMPLEMENTATION