INOPP Forum
Pharmacovigilance Requirements in Nigeria
Quote from VigiServe Admin on November 28, 2020, 9:14 AM
In Nigeria, Pharmacovigilance is regulated by the National Agency for Food and Drug Administration and Control (NAFDAC) through its Pharmacovigilance and Post-Marketing Surveillance (PV/PMS) Directorate. The system is robust, aligning with WHO standards and ICH principles, and actively promotes electronic reporting via the Med Safety App.
1. Clinical Safety (Clinical Trials)
Clinical trials require NAFDAC approval and adherence to ICH GCP standards.
Expedited Reporting (SUSARs): Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) consistent with ICH E2A:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).
Oversight: Sponsors are responsible for causality assessment, insurance coverage for trial-related injuries, and communication with NAFDAC and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Nigeria enforces strict post-approval obligations, including mandatory local personnel and electronic reporting.
Personnel: A Local Contact Person / Responsible Person for Pharmacovigilance is mandatory. This individual must be a qualified professional (Pharmacist or Physician), resident in Nigeria, and registered with NAFDAC.
Documentation: A Pharmacovigilance System Master File (PSMF) is required. It must be detailed, maintained, and available for NAFDAC inspections.
Incident Reporting (ICSRs):
Serious Cases: Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Platform: Electronic reporting via Med Safety App or VigiFlow.
Risk & Periodic Reporting:
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years), then annually.
Risk Management Plans (RMPs): Mandatory for new chemical entities, biologics, vaccines, and high-risk products (Nigeria-specific annex required).
Summary of Requirements
Component Requirement in Nigeria Regulatory Authority NAFDAC (PV/PMS Directorate) Local Responsible Person Mandatory (Pharmacist/Physician - Resident) PSMF Required (Maintained locally) SUSAR Reporting 7 days (fatal) / 15 days (other serious) ICSR Timelines 15 days (serious) / 90 days (non-serious) RMPs & PSURs Mandatory
In Nigeria, Pharmacovigilance is regulated by the National Agency for Food and Drug Administration and Control (NAFDAC) through its Pharmacovigilance and Post-Marketing Surveillance (PV/PMS) Directorate. The system is robust, aligning with WHO standards and ICH principles, and actively promotes electronic reporting via the Med Safety App.
1. Clinical Safety (Clinical Trials)
Clinical trials require NAFDAC approval and adherence to ICH GCP standards.
-
Expedited Reporting (SUSARs): Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) consistent with ICH E2A:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).
-
Oversight: Sponsors are responsible for causality assessment, insurance coverage for trial-related injuries, and communication with NAFDAC and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Nigeria enforces strict post-approval obligations, including mandatory local personnel and electronic reporting.
-
Personnel: A Local Contact Person / Responsible Person for Pharmacovigilance is mandatory. This individual must be a qualified professional (Pharmacist or Physician), resident in Nigeria, and registered with NAFDAC.
-
Documentation: A Pharmacovigilance System Master File (PSMF) is required. It must be detailed, maintained, and available for NAFDAC inspections.
-
Incident Reporting (ICSRs):
-
Serious Cases: Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
Platform: Electronic reporting via Med Safety App or VigiFlow.
-
-
Risk & Periodic Reporting:
-
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years), then annually.
-
Risk Management Plans (RMPs): Mandatory for new chemical entities, biologics, vaccines, and high-risk products (Nigeria-specific annex required).
-
Summary of Requirements
| Component | Requirement in Nigeria |
| Regulatory Authority | NAFDAC (PV/PMS Directorate) |
| Local Responsible Person | Mandatory (Pharmacist/Physician - Resident) |
| PSMF | Required (Maintained locally) |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious) |
| RMPs & PSURs | Mandatory |
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