Quote from VigiServe Admin on February 8, 2026, 8:19 AM

In Fiji, Pharmacovigilance is coordinated by the Fiji Pharmaceutical and Biomedical Supplies (FPBS) unit under the Ministry of Health and Medical Services. The system is basic and relies heavily on the WHO Pacific Regional Office for support. Interestingly, the country also utilizes VigiCarib tools for reporting, leveraging established platforms from the Caribbean network.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare and require Ministry of Health approval.

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in national law, 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 the Ministry or regional channels via forms or email.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders.

• Personnel & Infrastructure:

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

  • No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File.

• 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.

  • RMPs: Not required.

Summary of Requirements

Component	Requirement in Fiji
Regulatory Authority	FPBS (Ministry of Health)
Regional Framework	WHO / Pacific (uses VigiCarib)
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days - International practice)
Regional Alignment	WHO / Pacific