Quote from VigiServe Admin on February 6, 2026, 1:25 PM

In Guyana, Pharmacovigilance is managed by the Guyana Public Health Ministry through the Food and Drug Department. The system is basic, relying heavily on WHO minimum standards and regional support from CARPHA (Caribbean Public Health Agency) and the VigiCarib platform.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare and typically humanitarian. Without specific national legislation, practice aligns with international norms (ICH).

• Approvals: Required from the Ministry of Health and Ethics Committees.

• Expedited Reporting: Sponsors follow ICH E2A standards:

  • Fatal or Life-Threatening: Within 7 days.

  • Other Serious Unexpected: Within 15 days.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates may be requested (ICH E2F format).

• Submission: Direct to the Ministry via email or paper forms; no national electronic portal exists.

2. Post-Marketing Pharmacovigilance

There is no enforceable national PV system for Marketing Authorization Holders (MAHs). Reporting is largely voluntary.

• Personnel & Infrastructure:

  • Local QPPV: Not required.

  • PSMF: Not required.

• Incident Reporting (ICSRs):

  • Reporting is voluntary and spontaneous, primarily from the public sector.

  • Timelines: Not codified. The expectation is "prompt" reporting (regional practice aligns with 15 days for serious cases).

  • Platform: VigiCarib is used for regional submission to WHO-UMC.

• Risk & Periodic Reporting:

  • PSURs/PBRERs: Not routinely required. May be requested informally during renewal.

  • Risk Management Plans (RMPs): Not required.

Summary of Requirements

Component	Requirement in Guyana
Regulatory Authority	Guyana Public Health Ministry (Food and Drug Dept)
Regional Support	CARPHA / VigiCarib
Local QPPV / PSMF	Not required
Safety Reporting	Voluntary; via VigiCarib or forms
SUSAR Reporting	7–15 days (Best practice)
RMPs & PSURs	Not required