INOPP Forum
Pharmacovigilance Requirements in Gabon
Quote from VigiServe Admin on February 8, 2026, 7:53 AMIn Gabon, Pharmacovigilance is regulated by the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) under the Ministry of Health. The system operates under Decree No. 000123/PR/MSPP (2012) and Ministerial Order No. 0005/MSPP (2015), aligning with WHO and Africa CDC standards.
1. Clinical Safety (Clinical Trials)
Clinical trials are strictly regulated by the DPML and require adherence to international ethical norms.
Expedited Reporting: Sponsors must 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) are typically required annually or upon request (ICH E2F format).
Submission: Reports are submitted directly to the DPML 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 Gabon.
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.
Summary of Requirements
Component Requirement in Gabon Regulatory Authority DPML (Direction 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 Gabon, Pharmacovigilance is regulated by the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) under the Ministry of Health. The system operates under Decree No. 000123/PR/MSPP (2012) and Ministerial Order No. 0005/MSPP (2015), aligning with WHO and Africa CDC standards.
1. Clinical Safety (Clinical Trials)
Clinical trials are strictly regulated by the DPML and require adherence to international ethical norms.
-
Expedited Reporting: Sponsors must 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) are typically required annually or upon request (ICH E2F format).
-
Submission: Reports are submitted directly to the DPML 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 Gabon.
-
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.
-
Summary of Requirements
| Component | Requirement in Gabon |
| Regulatory Authority | DPML (Direction 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 |