Quote from VigiServe Admin on February 8, 2026, 2:04 AM

In Burkina Faso, Pharmacovigilance is regulated by the Direction Générale de la Pharmacie du Médicament et des Laboratoires (DGPML) under the Ministry of Health. The system operates on a basic to moderate level, governed by Decree No. 2010-157 and Ministerial Order No. 2017-002, with strong reliance on WHO and Africa CDC support.

1. Clinical Safety (Clinical Trials)

Clinical trials require authorization from the DGPML and adherence to international norms.

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While specific national timelines are 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.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates are typically required (ICH E2F format).

• Submission: Reports are submitted directly to the DGPML via email or standard forms; there is no dedicated electronic trial portal.

2. Post-Marketing Pharmacovigilance

Post-approval surveillance is minimalistic, focusing on national coordination through the Centre National de Pharmacovigilance (CNPV) rather than strict industry mandates.

• Personnel & Infrastructure:

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

  • No PSMF Mandate: Marketing Authorization Holders (MAHs) do not need to register or maintain a Pharmacovigilance System Master File in the country.

• Incident Reporting (ICSRs):

  • Reporting is spontaneous and voluntary, using VigiFlow, email, or paper forms.

  • Timelines: Not rigidly codified. The expectation is "prompt" reporting for serious or unexpected events (generally interpreted as 15 days).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory. Safety updates may be requested during registration renewal or variations.

  • RMPs: Not a standard requirement; risk assessment is reactive and often integrated with public health programs (e.g., malaria, vaccines).

Summary of Requirements

Component	Requirement in Burkina Faso
Regulatory Authority	DGPML (Direction Générale de la Pharmacie)
National Centre	Centre National de Pharmacovigilance (CNPV)
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (Expedited); DSURs (on request)
Regional Alignment	WHO / Africa CDC