BAHRAIN
BAHRAIN
Medwisdom Lifescience delivers fully NHRA-compliant pharmacovigilance services for Bahrain — including local Pharmacovigilance Officer, ADR reporting via the National Pharmacovigilance Centre (NPVC), PSUR/PBRER, RMP, and medical device vigilance under GCC harmonised guidelines.
Overview
Pharmacovigilance in Bahrain is regulated by the National Health Regulatory Authority (NHRA) through its Pharmacy & Drug Control Directorate. Bahrain is an active GCC member and implements the unified GCC Pharmacovigilance Guidelines (latest version 2023).
The National Pharmacovigilance Centre (NPVC) at NHRA collects, evaluates, and analyses adverse drug reactions and medical device incidents, contributing data to WHO VigiBase. All Marketing Authorization Holders (MAHs) and local agents must appoint a qualified local PV responsible person and maintain an active safety monitoring system.
Pharmacovigilance Requirements & Approval Timelines
Drug registration in Bahrain (including PV documentation) typically takes 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
National Health Regulatory Authority (NHRA) – Pharmacy & Drug Control Directorate - Local Pharmacovigilance Responsible Person
Mandatory; must be Bahrain-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
Mandatory incident reporting and post-market surveillance via NHRA portal
Challenges in Bahrain Pharmacovigilance
Although Bahrain has a well-structured system, common GCC challenges persist:
- Under-reporting from private sector and community pharmacies
- Limited number of dedicated PV staff in smaller organisations
- Need for ongoing training in causality assessment and signal detection
- Coordination between local agents and global MAHs during submissions
Medwisdom resolves these with dedicated Bahrain-based officers, automated tools, and proven NHRA acceptance.
Our Pharmacovigilance Services for Bahrain
- Local PV Responsible Person
Bahrain/GCC-certified officer with 24/7 coverage - ICSR & ADR Management
Collection, processing, and submission to NPVC portal - 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 Bahrain/GCC-specific searches - Training Programs
For medical, regulatory, sales, and distributor teams - Audit & Inspection Support
Mock audits and NHRA inspection readiness
Why Choose Medwisdom for Bahrain Pharmacovigilance
- Deep expertise in GCC & Bahrain NHRA regulations
- Local Bahrain-based PV officer fully accepted by NHRA
- 100% compliance with GCC reporting timelines
- End-to-end service for drugs, biologics, vaccines & medical devices
- Strong relationships with NHRA and National Pharmacovigilance Centre
- Seamless support during registration, renewal, and post-marketing
- 24/7 emergency safety support
GCC/Bahrain 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 – Bahrain
- National Health Regulatory Authority (NHRA)
Main portal and guidelines
www.nhra.bh - NHRA Pharmacovigilance Section
ADR reporting and safety bulletins
nhra.bh/Departments/Pharmacy - GCC Pharmacovigilance Guidelines
Unified framework applicable in Bahrain
GCC Regulatory Portal