Quote from VigiServe Admin on February 8, 2026, 10:57 AM

In Equatorial Guinea, the pharmacovigilance system is non-operational. There is no functioning national center, no legislation, and the country is not a member of the WHO PIDM. Safety monitoring is virtually non-existent outside of ad-hoc humanitarian projects.

1. Clinical Safety (Clinical Trials)

Clinical trials are extremely rare and typically humanitarian in nature.

• 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 best practice.

• Submission: Reports go directly to the Ministry of Health or Ethics Committees.

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: None.

  • Practice: Reporting is negligible.

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not required.

Summary of Requirements

Component	Requirement in Equatorial Guinea
Regulatory Authority	MoH (Ministerio de Sanidad)
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	Spanish (Official)