Quote from VigiServe Admin on February 8, 2026, 1:39 PM

In Djibouti, Pharmacovigilance is regulated by the Direction de la Pharmacie et du Médicament (DPM) under Decree No. 2016-123 and Ministerial Order No. 2018-045. The system is WHO-aligned and focuses on national coordination through the Centre National de Pharmacovigilance (CNPV).

1. Clinical Safety (Clinical Trials)

Clinical trials require DPM authorization and adherence to international standards.

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not rigidly codified, the practice aligns with international (ICH E2A) standards:

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

  • Other Serious Unexpected: Within 15 calendar days.

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

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files.

• Personnel & Infrastructure:

  • No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Djibouti.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous.

  • 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 Djibouti
Regulatory Authority	DPM (Direction de la Pharmacie)
Framework	Decree 2016 / Order 2018
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days - International practice)
Submission Language	French

---