INOPP Forum
Pharmacovigilance requirements in Syria
Quote from VigiServe Admin on February 6, 2026, 1:32 PMIn Syria, the Pharmacovigilance infrastructure is severely limited due to ongoing conflict and institutional fragmentation. Oversight is claimed by the Directorate of Medicines and Medical Supplies (Ministry of Health, Damascus) and various parallel structures, but no unified national enforcement exists.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare, typically humanitarian, and lack a codified national guideline. Practice follows international standards (ICH) in the absence of local law.
Approvals: Required from the Ministry of Health (fragmented process).
Expedited Reporting: Sponsors generally follow ICH E2A best practices:
Fatal or Life-Threatening: Within 7 days.
Other Serious Unexpected: Within 15 days.
Periodic Reporting: Development Safety Update Reports (DSURs) are submitted only if required by the sponsor’s ethics committee or funder.
Oversight: Direct reporting to the Ministry of Health or Ethics Committees; no central Pharmacovigilance unit is involved.
2. Post-Marketing Pharmacovigilance
There is no operational, enforceable national system for Marketing Authorization Holders (MAHs).
Governance: No active national Pharmacovigilance center. Monitoring is ad-hoc, driven by NGOs (e.g., WHO, UNICEF) and emergency programs.
Personnel & Infrastructure:
Local QPPV: Not required or enforced.
PSMF: Not required.
Incident Reporting (ICSRs):
Timelines: No mandatory timelines. Serious events are expected to be reported "promptly" (best practice), but volumes are negligible.
Submission: Paper forms or email; no national electronic system.
Risk & Periodic Reporting:
PSURs/PBRERs: Not required.
Risk Management Plans (RMPs): Not required.
Summary of Requirements
Component Requirement in Syria Regulatory Authority Directorate of Medicines (MoH Damascus) / Fragmented 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 Syria, the Pharmacovigilance infrastructure is severely limited due to ongoing conflict and institutional fragmentation. Oversight is claimed by the Directorate of Medicines and Medical Supplies (Ministry of Health, Damascus) and various parallel structures, but no unified national enforcement exists.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare, typically humanitarian, and lack a codified national guideline. Practice follows international standards (ICH) in the absence of local law.
-
Approvals: Required from the Ministry of Health (fragmented process).
-
Expedited Reporting: Sponsors generally follow ICH E2A best practices:
-
Fatal or Life-Threatening: Within 7 days.
-
Other Serious Unexpected: Within 15 days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are submitted only if required by the sponsor’s ethics committee or funder.
-
Oversight: Direct reporting to the Ministry of Health or Ethics Committees; no central Pharmacovigilance unit is involved.
2. Post-Marketing Pharmacovigilance
There is no operational, enforceable national system for Marketing Authorization Holders (MAHs).
-
Governance: No active national Pharmacovigilance center. Monitoring is ad-hoc, driven by NGOs (e.g., WHO, UNICEF) and emergency programs.
-
Personnel & Infrastructure:
-
Local QPPV: Not required or enforced.
-
PSMF: Not required.
-
-
Incident Reporting (ICSRs):
-
Timelines: No mandatory timelines. Serious events are expected to be reported "promptly" (best practice), but volumes are negligible.
-
Submission: Paper forms or email; no national electronic system.
-
-
Risk & Periodic Reporting:
-
PSURs/PBRERs: Not required.
-
Risk Management Plans (RMPs): Not required.
-
Summary of Requirements
| Component | Requirement in Syria |
| Regulatory Authority | Directorate of Medicines (MoH Damascus) / Fragmented |
| 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 |