INOPP Forum
Pharmacovigilance requirements in Burundi
Quote from VigiServe Admin on February 8, 2026, 2:08 AMIn Burundi, Pharmacovigilance is regulated by the Direction Générale de la Pharmacie, du Médicament et des Laboratoires (DG PML) under the Ministry of Public Health. The system operates under Decree No. 100/183 (2014) and is aligned with WHO and Africa CDC standards, functioning with basic capacity and limited enforcement.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and require authorization from the DG PML and adherence to international ethical norms.
Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). Although not codified in rigid statutes, 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) are typically required annually or upon request (ICH E2F format).
Submission: Reports are submitted directly to the DG PML via email or standard forms; there is no dedicated electronic trial portal.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic, prioritizing national coordination through the Centre National de Pharmacovigilance (CNPV) over complex industry mandates.
Governance: The CNPV collects data and contributes to VigiBase via VigiFlow.
Personnel & Infrastructure:
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Burundi.
No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File in the country.
Incident Reporting (ICSRs):
Reporting is spontaneous and voluntary.
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., vaccines, malaria).
Summary of Requirements
Component Requirement in Burundi Regulatory Authority DG PML (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
In Burundi, Pharmacovigilance is regulated by the Direction Générale de la Pharmacie, du Médicament et des Laboratoires (DG PML) under the Ministry of Public Health. The system operates under Decree No. 100/183 (2014) and is aligned with WHO and Africa CDC standards, functioning with basic capacity and limited enforcement.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and require authorization from the DG PML and adherence to international ethical norms.
-
Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). Although not codified in rigid statutes, 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) are typically required annually or upon request (ICH E2F format).
-
Submission: Reports are submitted directly to the DG PML via email or standard forms; there is no dedicated electronic trial portal.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic, prioritizing national coordination through the Centre National de Pharmacovigilance (CNPV) over complex industry mandates.
-
Governance: The CNPV collects data and contributes to VigiBase via VigiFlow.
-
Personnel & Infrastructure:
-
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Burundi.
-
No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File in the country.
-
-
Incident Reporting (ICSRs):
-
Reporting is spontaneous and voluntary.
-
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., vaccines, malaria).
-
Summary of Requirements
| Component | Requirement in Burundi |
| Regulatory Authority | DG PML (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 |