SAUDI ARABIA
SAUDI ARABIA
Medwisdom Lifescience provides fully SFDA-compliant pharmacovigilance services for the Saudi market — including Local Safety Responsible (LSR) services, PSMF maintenance, Narcissus/GHAD submissions, audit preparation, and end-to-end drug & medical device safety management.
Overview
Saudi Arabia has one of the most advanced and strictly enforced pharmacovigilance systems in the GCC region. The Saudi Food & Drug Authority (SFDA) oversees all drug safety and medical device vigilance activities through its National Pharmacovigilance Center (NPC) and dedicated online portals (Narcissus & GHAD).
All Marketing Authorization Holders (MAHs), importers, distributors, and local agents are legally required to establish and maintain a robust PV system in full compliance with the SFDA Pharmacovigilance Guidelines (Good Vigilance Practice Manual), ICH, and GVP standards.
Key Pharmacovigilance Requirements in Saudi Arabia
- Local Pharmacovigilance System Master File (PSMF)
Saudi-specific PSMF with organizational structure, QPPV/LSR details, SOPs, database info, and audit CAPAs — available for SFDA inspection anytime - Qualified Person for PV (QPPV) + Local Safety Responsible (LSR)
Mandatory LSR residing in KSA or certified local representative with 24/7 availability - Adverse Event Reporting Timelines
• Serious cases: 7 calendar days
• Non-serious cases: 15 calendar days - Periodic Reports & RMP
PSUR/PBRER, DSUR, Saudi RMP, local addendums, and risk minimization documentation - Literature Monitoring
Weekly/bi-weekly Saudi & GCC-specific literature screening - SFDA Inspections & Audits
Scheduled and unannounced inspections with severe penalties for non-compliance - Medical Device Vigilance
Mandatory incident reporting, FSCA, and post-market surveillance via MDS-Vigilance platform
Our Pharmacovigilance Services for Saudi Arabia
- Local Safety Responsible (LSR) Services
Certified LSR with 24/7 availability & direct SFDA coordination - PSMF Development & Maintenance
Full Saudi-specific PSMF creation and ongoing updates - ICSR Case Processing & Reporting
Via Narcissus portal with 7/15-day compliance - PSUR/PBRER, DSUR, RMP
Preparation & submission as per SFDA schedule
- Medical Device Vigilance
Incident reporting, FSCA, PMS plans via GHAD/MDS - Literature & Local Evidence Monitoring
Weekly Saudi/GCC searches - SFDA Audit & Inspection Readiness
Mock audits, CAPA management, full documentation support - Training & SOP Development
For MAH staff, distributors, and local agents
Why Choose Medwisdom for Saudi Pharmacovigilance
- Deep expertise in SFDA GVP and Narcissus/GHAD portals
- Certified Local Safety Responsible (LSR) with proven SFDA acceptance
- 100% compliance track record — zero critical findings in SFDA inspections
- Full support for drugs, biologics, vaccines, medical devices, cosmetics & nutraceuticals
- End-to-end service: PSMF → case processing → reporting → audit defense
- Training programs for distributors and local agents
- 24/7 emergency safety support
SFDA Reporting Timelines
| Activity | Timeline |
|---|---|
| Serious Adverse Events (Domestic & Foreign) | 7 calendar days |
| Non-serious Adverse Events | 15 calendar days |
| PSUR / PBRER Submission | As per product-specific SFDA schedule |
| RMP Submission | With registration & upon request |
| Medical Device Incidents | As per risk classification (immediate to 30 days) |
Official SFDA & Regulatory Links
- SFDA Pharmacovigilance Guidelines (GVP Manual)
beta.sfda.gov.sa/en/regulations - SFDA Drug Safety Alerts & Communications
www.sfda.gov.sa/en/drug-safety - Narcissus Portal – Adverse Event Reporting
ade.sfda.gov.sa - National Pharmacovigilance & Drug Safety Center
www.sfda.gov.sa/en/npc