Quote from VigiServe Admin on February 8, 2026, 8:06 AM

In Guinea-Bissau, the Pharmacovigilance system is largely non-functional and relies heavily on international humanitarian support. The National Directorate of Pharmacy (Direção Nacional de Farmácia) under the Ministry of Public Health is the nominal authority, but there is no operational national center or enforcement mechanism.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare and typically driven by humanitarian research (e.g., vaccines).

• Framework: No codified national guideline; sponsors follow international standards (ICH E2A/E2F).

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

• Submission: Reports go directly to the Ministry of Public Health 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.

• 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 reporting is sporadic and paper-based.

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not required or enforced.

  • Signal Detection: Non-existent at the national level.

Summary of Requirements

Component	Requirement in Guinea-Bissau
Regulatory Authority	Direção Nacional de Farmácia (Nominal)
Framework	Decree 3/2008 (Unenforced) / Humanitarian
Local QPPV / PSMF	Not required
Safety Reporting	Ad-hoc / "Prompt" (Voluntary)
Clinical Reporting	SUSARs (7/15 days - International practice)
Regional Alignment	WHO (Emergency context)