INOPP Forum
Pharmacovigilance requirements in Libya
Quote from VigiServe Admin on February 6, 2026, 1:08 PMIn Libya, the Pharmacovigilance system is severely underdeveloped and functionally fragmented due to ongoing conflict. Oversight is split between the National Center for Medicines Control (NCMC) in Tripoli and parallel authorities in eastern Libya, with no unified national enforcement.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and primarily driven by humanitarian or research initiatives. There is no codified national guideline; practice relies on international standards.
Approvals: Required from the Ministry of Health (process varies by region/authority).
Expedited Reporting: Sponsors generally follow ICH E2A standards in the absence of local law:
Fatal or Life-Threatening: Within 7 days.
Other Serious Unexpected: Within 15 days.
Periodic Reporting: Development Safety Update Reports (DSURs) are submitted if required by the sponsor’s ethics committee or funder.
Oversight: Direct reporting to the Ministry of Health or Ethics Committees; no central PV unit is involved.
2. Post-Marketing Pharmacovigilance
There is currently no enforceable national system. MAHs face no practical obligations regarding local personnel or routine reporting.
Governance: No functional national PV center. Activities are limited to ad-hoc monitoring by WHO, NGOs (e.g., MSF, ICRC), and public health programs (vaccines).
Personnel & Infrastructure:
Local QPPV: Not required or enforced.
PSMF: Not required.
Incident Reporting (ICSRs):
Timelines: No mandatory timelines are enforced. Serious ADRs are expected to be reported "promptly" (best practice: 15 days), but volumes are negligible outside humanitarian contexts.
Submission: Paper forms or email; no national electronic system exists.
Risk & Periodic Reporting:
PSURs/PBRERs: Not required. Safety updates are rarely requested during registration renewal.
Risk Management Plans (RMPs): Not required. Risk management is reactive and limited to emergency contexts.
Summary of Requirements
Component Requirement in Libya Regulatory Authority Fragmented (NCMC Tripoli / LMA Benghazi) Local QPPV Not required PSMF Not required SUSAR Reporting Ad-hoc / Best practice (7–15 days) ICSR Timelines No enforcement (Best practice: Prompt) RMPs & PSURs Not required
In Libya, the Pharmacovigilance system is severely underdeveloped and functionally fragmented due to ongoing conflict. Oversight is split between the National Center for Medicines Control (NCMC) in Tripoli and parallel authorities in eastern Libya, with no unified national enforcement.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and primarily driven by humanitarian or research initiatives. There is no codified national guideline; practice relies on international standards.
-
Approvals: Required from the Ministry of Health (process varies by region/authority).
-
Expedited Reporting: Sponsors generally follow ICH E2A standards in the absence of local law:
-
Fatal or Life-Threatening: Within 7 days.
-
Other Serious Unexpected: Within 15 days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are submitted if required by the sponsor’s ethics committee or funder.
-
Oversight: Direct reporting to the Ministry of Health or Ethics Committees; no central PV unit is involved.
2. Post-Marketing Pharmacovigilance
There is currently no enforceable national system. MAHs face no practical obligations regarding local personnel or routine reporting.
-
Governance: No functional national PV center. Activities are limited to ad-hoc monitoring by WHO, NGOs (e.g., MSF, ICRC), and public health programs (vaccines).
-
Personnel & Infrastructure:
-
Local QPPV: Not required or enforced.
-
PSMF: Not required.
-
-
Incident Reporting (ICSRs):
-
Timelines: No mandatory timelines are enforced. Serious ADRs are expected to be reported "promptly" (best practice: 15 days), but volumes are negligible outside humanitarian contexts.
-
Submission: Paper forms or email; no national electronic system exists.
-
-
Risk & Periodic Reporting:
-
PSURs/PBRERs: Not required. Safety updates are rarely requested during registration renewal.
-
Risk Management Plans (RMPs): Not required. Risk management is reactive and limited to emergency contexts.
-
Summary of Requirements
| Component | Requirement in Libya |
| Regulatory Authority | Fragmented (NCMC Tripoli / LMA Benghazi) |
| Local QPPV | Not required |
| PSMF | Not required |
| SUSAR Reporting | Ad-hoc / Best practice (7–15 days) |
| ICSR Timelines | No enforcement (Best practice: Prompt) |
| RMPs & PSURs | Not required |