INOPP Forum
Pharmacovigilance Requirements in Niger
Quote from VigiServe Admin on February 8, 2026, 10:40 AMIn Niger, Pharmacovigilance is regulated by the Direction de la Pharmacie et du Médicament (DPM) under the Ministry of Public Health. The system operates under Decree No. 2010-157 and Ministerial Order No. 2017-002, aligning with WHO and Africa CDC standards.
1. Clinical Safety (Clinical Trials)
Clinical trials require authorization from the DPM and adherence to international ethical 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) are typically required annually or upon request.
Submission: Reports are submitted directly to the DPM via email or forms.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic, focusing on national coordination through the Centre National de Pharmacovigilance (CNPV).
Personnel & Infrastructure:
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Niger.
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. Updates may be requested during registration renewal.
RMPs: Not a standard requirement; risk assessment is reactive.
Summary of Requirements
Component Requirement in Niger Regulatory Authority DPM (Direction de la Pharmacie) Framework Decree 2010 / WHO / Africa CDC Local QPPV / PSMF Not required Safety Reporting Spontaneous; "Prompt" reporting Clinical Reporting SUSARs (7/15 days - International practice) Regional Alignment WHO / West Africa
In Niger, Pharmacovigilance is regulated by the Direction de la Pharmacie et du Médicament (DPM) under the Ministry of Public Health. The system operates under Decree No. 2010-157 and Ministerial Order No. 2017-002, aligning with WHO and Africa CDC standards.
1. Clinical Safety (Clinical Trials)
Clinical trials require authorization from the DPM and adherence to international ethical 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) are typically required annually or upon request.
-
Submission: Reports are submitted directly to the DPM via email or forms.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic, focusing on national coordination through the Centre National de Pharmacovigilance (CNPV).
-
Personnel & Infrastructure:
-
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Niger.
-
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. Updates may be requested during registration renewal.
-
RMPs: Not a standard requirement; risk assessment is reactive.
-
Summary of Requirements
| Component | Requirement in Niger |
| Regulatory Authority | DPM (Direction de la Pharmacie) |
| Framework | Decree 2010 / WHO / Africa CDC |
| Local QPPV / PSMF | Not required |
| Safety Reporting | Spontaneous; "Prompt" reporting |
| Clinical Reporting | SUSARs (7/15 days - International practice) |
| Regional Alignment | WHO / West Africa |