Quote from VigiServe Admin on February 10, 2026, 9:23 AM

In Tuvalu, the pharmacovigilance system is non-operational. There is no dedicated legal framework, national center, or enforcement of obligations. Activities are limited to ad-hoc support from the WHO Pacific Regional Office.

1. Clinical Safety (Clinical Trials)

Clinical trials are virtually non-existent and typically humanitarian.

• Framework: No national guidelines; sponsors follow international standards (ICH E2A).

• Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs as a matter of best practice.

• Submission: Reports go directly to the Ministry of Health (MoH).

2. Post-Marketing Pharmacovigilance

There are no enforceable local obligations for Marketing Authorization Holders.

• Personnel & Infrastructure:

  • No Local QPPV: Not required.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous.

  • Practice: Reporting is negligible; serious ADRs are expected "promptly" but handled ad-hoc.

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not required.

Summary of Requirements

Component	Requirement in Tuvalu
Regulatory Authority	MoH (Ministry of Health)
Framework	Non-functional / Ad-hoc
Local QPPV / PSMF	Not required
Safety Reporting	None / Ad-hoc
Clinical Reporting	SUSARs (7/15 days - International practice)
Submission Language	English