INOPP Forum
Pharmacovigilance requirements in Yemen
Quote from VigiServe Admin on February 8, 2026, 4:59 AMIn Yemen, the Pharmacovigilance system is severely limited and largely non-functional due to prolonged conflict and fragmented governance. Regulation is split between the Supreme National Authority for Medicines and Medical Supplies (SNA-MMS) in Sana’a and the Ministry of Health in Aden/Marib. There is no centralized enforcement or active national PV center.
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare and typically humanitarian or research-driven.
Framework: No codified national guideline; sponsors follow international standards (ICH E2A).
Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs.
Submission: Reports go directly to the relevant MoH faction or ethics committees; no central unit exists.
2. Post-Marketing Pharmacovigilance
There are no practical local obligations for Marketing Authorization Holders. The system relies entirely on ad-hoc reporting from international NGOs (MSF, ICRC) and WHO emergency programs.
Personnel & Infrastructure:
No Local QPPV: Not required.
No PSMF Mandate: Not required.
Incident Reporting (ICSRs):
Enforcement: None. No mandatory timelines exist.
Practice: Serious events are expected to be reported "promptly" (ad-hoc) via paper or email.
Risk & Periodic Reporting:
PSURs/RMPs: Not required or enforced.
Signal Detection: Non-existent at the national level.
Summary of Requirements
Component Requirement in Yemen Regulatory Authority Fragmented (SNA-MMS Sana’a / MoH Aden) Framework Non-functional / WHO Emergency Support Local QPPV / PSMF Not required Safety Reporting Ad-hoc / None enforced Clinical Reporting SUSARs (7/15 days - International practice) Regional Alignment WHO (Emergency context)
In Yemen, the Pharmacovigilance system is severely limited and largely non-functional due to prolonged conflict and fragmented governance. Regulation is split between the Supreme National Authority for Medicines and Medical Supplies (SNA-MMS) in Sana’a and the Ministry of Health in Aden/Marib. There is no centralized enforcement or active national PV center.
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare and typically humanitarian or research-driven.
-
Framework: No codified national guideline; sponsors follow international standards (ICH E2A).
-
Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs.
-
Submission: Reports go directly to the relevant MoH faction or ethics committees; no central unit exists.
2. Post-Marketing Pharmacovigilance
There are no practical local obligations for Marketing Authorization Holders. The system relies entirely on ad-hoc reporting from international NGOs (MSF, ICRC) and WHO emergency programs.
-
Personnel & Infrastructure:
-
No Local QPPV: Not required.
-
No PSMF Mandate: Not required.
-
-
Incident Reporting (ICSRs):
-
Enforcement: None. No mandatory timelines exist.
-
Practice: Serious events are expected to be reported "promptly" (ad-hoc) via paper or email.
-
-
Risk & Periodic Reporting:
-
PSURs/RMPs: Not required or enforced.
-
Signal Detection: Non-existent at the national level.
-
Summary of Requirements
| Component | Requirement in Yemen |
| Regulatory Authority | Fragmented (SNA-MMS Sana’a / MoH Aden) |
| Framework | Non-functional / WHO Emergency Support |
| Local QPPV / PSMF | Not required |
| Safety Reporting | Ad-hoc / None enforced |
| Clinical Reporting | SUSARs (7/15 days - International practice) |
| Regional Alignment | WHO (Emergency context) |