INOPP Forum
Pharmacovigilance Requirements in Eritrea
Quote from VigiServe Admin on February 8, 2026, 10:52 AMIn Eritrea, the Pharmacovigilance system is non-operational. There is no legal framework, no national center, and the country is not a member of the WHO PIDM. Any safety monitoring is strictly ad-hoc, driven by international NGOs or specific WHO vaccination campaigns.
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare and typically humanitarian.
Framework: No national guidelines; sponsors follow international standards (ICH E2A).
Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs as a matter of best practice.
Submission: Reports go directly to the MoH or Ethics Committees.
2. Post-Marketing Pharmacovigilance
There are no enforceable local obligations for Marketing Authorization Holders.
Personnel & Infrastructure:
No Local QPPV: Not required.
No PSMF Mandate: Not required.
Incident Reporting (ICSRs):
Enforcement: None.
Practice: Reporting is negligible and limited to emergency programs.
Risk & Periodic Reporting:
PSURs/RMPs: Not required.
Summary of Requirements
Component Requirement in Eritrea Regulatory Authority NMFA (National Medicines & Food Admin) / MoH Framework Non-functional / Ad-hoc Local QPPV / PSMF Not required Safety Reporting None / Ad-hoc Clinical Reporting SUSARs (7/15 days - International practice) Submission Language English (De facto)
In Eritrea, the Pharmacovigilance system is non-operational. There is no legal framework, no national center, and the country is not a member of the WHO PIDM. Any safety monitoring is strictly ad-hoc, driven by international NGOs or specific WHO vaccination campaigns.
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare and typically humanitarian.
-
Framework: No national guidelines; sponsors follow international standards (ICH E2A).
-
Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs as a matter of best practice.
-
Submission: Reports go directly to the MoH or Ethics Committees.
2. Post-Marketing Pharmacovigilance
There are no enforceable local obligations for Marketing Authorization Holders.
-
Personnel & Infrastructure:
-
No Local QPPV: Not required.
-
No PSMF Mandate: Not required.
-
-
Incident Reporting (ICSRs):
-
Enforcement: None.
-
Practice: Reporting is negligible and limited to emergency programs.
-
-
Risk & Periodic Reporting:
-
PSURs/RMPs: Not required.
-
Summary of Requirements
| Component | Requirement in Eritrea |
| Regulatory Authority | NMFA (National Medicines & Food Admin) / MoH |
| Framework | Non-functional / Ad-hoc |
| Local QPPV / PSMF | Not required |
| Safety Reporting | None / Ad-hoc |
| Clinical Reporting | SUSARs (7/15 days - International practice) |
| Submission Language | English (De facto) |