Quote from VigiServe Admin on February 10, 2026, 10:12 AM

In Côte d’Ivoire (Ivory Coast), pharmacovigilance is coordinated by the Direction de la Pharmacie et du Médicament (DPM) and the Autorité Ivoirienne de Régulation Pharmaceutique (AIRP). The system is moderately developed and aligned with WHO standards, with recent efforts to strengthen regulation through regional harmonization.

 

1. Clinical Safety (Clinical Trials)

Clinical trials require approval from the DPM/Ministry of Health and adherence to ICH GCP standards.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs):

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are required annually or periodically.

• Submission: Reports go directly to DPM channels via forms or email.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files, though spontaneous reporting is encouraged.

• Personnel & Infrastructure:

  • No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Côte d’Ivoire.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous; active surveillance in public health programs.

  • Timelines: "Prompt" reporting is expected for serious cases (generally interpreted as 15 days).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory; may be requested.

  • RMPs: Reactive; not a standard requirement.

Summary of Requirements

Component	Requirement in Côte d’Ivoire
Regulatory Authority	DPM / AIRP
Framework	Public Health Code / WHO
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days)
Submission Language	French