Quote from VigiServe Admin on February 8, 2026, 8:11 AM

In Palau, the Pharmacovigilance system is minimalistic and reliant on regional support. There is no operational national center or standalone legislation. The Ministry of Health and Human Services (MoHHS) serves as the contact point, but activities are largely coordinated through the WHO Pacific Islands Regional Centre.

1. Clinical Safety (Clinical Trials)

Clinical trials are extremely rare and typically humanitarian in nature.

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

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

• Submission: Reports go directly to the MoHHS or Ethics Committees; no central PV unit exists.

2. Post-Marketing Pharmacovigilance

There are no practical local obligations for Marketing Authorization Holders. The system operates on an ad-hoc basis with support from the Pacific Pharmacovigilance Network.

• Personnel & Infrastructure:

  • No Local QPPV: Not required.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: None.

  • Practice: Serious events are expected to be reported "promptly" (WHO expectation), but volumes are negligible.

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not required or enforced.

  • Signal Detection: Handled regionally by WHO/Pacific Centre.

Summary of Requirements

Component	Requirement in Palau
Regulatory Authority	MoHHS (Ministry of Health & Human Services)
Regional Framework	WHO / Pacific Islands Network
Local QPPV / PSMF	Not required
Safety Reporting	Ad-hoc / "Prompt" (Voluntary)
Clinical Reporting	SUSARs (7/15 days - International practice)
Regional Alignment	WHO / Pacific