Quote from VigiServe Admin on February 8, 2026, 10:46 AM

In Eswatini, Pharmacovigilance is regulated by the Eswatini Medicines Regulatory Authority (EMRA) under the Medicines and Related Substances Act 2016. The system is WHO-aligned and focuses on public health program integration (HIV/TB), functioning with limited industry enforcement.

1. Clinical Safety (Clinical Trials)

Clinical trials require EMRA authorization and adherence to international standards.

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not rigidly codified, the practice aligns with international (ICH E2A) standards:

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

  • Other Serious Unexpected: Within 15 calendar days.

• Submission: Reports go directly to EMRA via email or forms.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files.

• Personnel & Infrastructure:

  • No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Eswatini.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous.

  • Timelines: "Prompt" reporting is expected for serious cases (generally interpreted as 15 days).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory; may be requested.

  • RMPs: Reactive; not a standard requirement.

Summary of Requirements

Component	Requirement in Eswatini
Regulatory Authority	EMRA (Eswatini Medicines Regulatory Authority)
Framework	Act 2016 / WHO / SADC
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days - International practice)
Regional Alignment	WHO / SADC