OMAN
OMAN
Medwisdom Lifescience provides fully compliant pharmacovigilance services for Oman in line with Ministry of Health (MOH) and GCC guidelines — including local PV officer, ADR reporting via the National Pharmacovigilance Center, PSUR/PBRER, RMP, and medical device vigilance.
Overview
Pharmacovigilance in Oman is regulated by the Directorate General of Pharmaceutical Affairs & Drug Control (DGPADC) under the Ministry of Health (MOH). Oman is an active member of the GCC Pharmacovigilance Working Group and fully implements the unified GCC Pharmacovigilance Guidelines (latest version 2023).
The National Pharmacovigilance Center (NPC) at the MOH receives and evaluates all adverse drug reactions and medical device incidents, contributing data to WHO’s VigiBase. All Marketing Authorization Holders (MAHs) and local agents must maintain a robust PV systems and appoint a qualified local PV responsible person.
Pharmacovigilance Requirements & Approval Timelines
Drug registration in Oman, which includes PV system description and RMP, takes approximately 6–12 months via the GCC centralized procedure or national route. Medical devices follow a risk-based classification with registration timelines of 3–9 months.
- Regulatory Authority
Directorate General of Pharmaceutical Affairs & Drug Control (DGPADC), MOH Oman - Local PV Responsible Person
Mandatory; must be resident or certified representative with 24/7 availability - GCC PV Guideline Compliance
PSMF, SOPs, safety database, literature monitoring, and signal detection required - PV for Medical Devices
Incident reporting and post-market surveillance through MOH electronic system
Challenges in Oman Pharmacovigilance
Despite strong infrastructure, Oman faces typical GCC challenges such as underreporting of ADRs, limited awareness among healthcare professionals, and occasional delays in regulatory feedback.
- Underreporting of spontaneous ADRs from hospitals and community pharmacies
- Limited dedicated PV staff in some institutions
- Need for continuous training on causality assessment and signal detection
- Coordination between local agents and global MAHs
Medwisdom overcomes these with active training programs, automated reporting tools, and dedicated Oman-based support.
Our Pharmacovigilance Services for Oman
- Local PV Responsible Person
Oman/GCC-certified officer with 24/7 coverage and MOH coordination - ICSR & ADR Management
Collection, processing, and submission to National Pharmacovigilance Center - PSUR/PBRER & RMP
Full preparation and timely submission per GCC schedule - Medical Device Vigilance
Incident reporting and FSCA coordination
- PSMF Development & Maintenance
GCC-compliant master file with regular updates - Literature & Signal Monitoring
Weekly Oman/GCC-specific searches - Training Programs
For medical, regulatory, sales teams and local agents - Audit & Inspection Support
Mock audits and readiness for MOH inspections
Why Choose Medwisdom for Oman Pharmacovigilance
- Deep expertise in GCC & Oman MOH regulations
- Local/GCC-certified PV officer accepted by authorities
- 100% compliance with GCC reporting timelines
- End-to-end service for drugs, biologics, vaccines & medical devices
- Strong relationships with Oman NPC and DGPADC
- Proven support during registration and renewals
- 24/7 emergency safety support
GCC/Oman Reporting Timelines
| Activity | Timeline |
|---|---|
| Serious ADR (Domestic & Foreign) | 7 calendar days |
| Non-serious ADR | 15 calendar days |
| PSUR/PBRER Submission | 60–90 days after data lock point |
| RMP Submission | With registration or when required |
| Medical Device Incidents | Immediate to 30 days (risk-based) |
Official Pharmacovigilance Resources – Oman
- Ministry of Health Oman – Pharmacovigilance
National reporting portal and guidelines
moh.gov.om/en/pharmacovigilance - DGPADC Drug Registration & PV
Registration and safety updates
moh.gov.om/en/dgpadc - GCC Pharmacovigilance Guidelines
Unified GCC framework applicable in Oman
GCC Regulatory Portal