Quote from VigiServe Admin on February 10, 2026, 11:19 AM

In São Tomé and Príncipe, the pharmacovigilance system is non-operational. There is no modern legal framework, national center, or active membership in the WHO PIDM. Activities are limited to ad-hoc support from WHO and NGOs, particularly during vaccination campaigns.

1. Clinical Safety (Clinical Trials)

Clinical trials are extremely rare 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/Ad-hoc.

  • Practice: Reporting is negligible; serious ADRs are handled ad-hoc.

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not required.

Summary of Requirements

Component	Requirement in São Tomé and Príncipe
Regulatory Authority	MoH (Ministério da Saúde)
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	Portuguese