Quote from VigiServe Admin on November 28, 2020, 6:06 AM

Pharmacovigilance Requirements in Bahrain

The pharmacovigilance (PV) system in **Bahrain** is managed by the **National Health Regulatory Authority (NHRA)** under the **Ministry of Health**, with a focus on post-marketing surveillance, ADR/AEFI monitoring, signal detection, risk assessment, inspections, alerts, and regulatory actions (e.g., recalls, label changes). Bahrain is an **associate member** of the WHO Programme for International Drug Monitoring (PIDM) since 2002, contributing limited reports to VigiBase.

The system remains relatively basic compared to more advanced GCC peers (e.g., Kuwait with KuGVP v6 in 2026, Saudi SFDA GVP), relying on **Arab Good Pharmacovigilance Practices (GVP)** guidelines (Version 3, 2015) as a harmonization model, WHO principles, and NHRA-specific requirements. No standalone comprehensive national GVP equivalent (like Kuwait's) is publicly prominent as of 2026; operations emphasize spontaneous reporting and compliance during registration/renewal.

**Legal Framework and Governance**
- Regulated by NHRA laws/regulations (e.g., Pharmacy & Pharmaceutical Products Regulation, Medicine Licensing Guideline v4.1 October 2025).
- NHRA's Pharmacy & Pharmaceutical Products Regulation Section handles PV aspects (ADR reporting, safety data in licensing/renewal).
- Emphasis on quality/safety oversight, counterfeit detection, and public health integration (e.g., vaccines).

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/importers must monitor safety and report suspected adverse events to NHRA.
- **No mandatory local Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is explicitly required in public sources (unlike stricter GCC neighbors).
- **No formal PV System Master File (PSMF)** registration/location mandate.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- Suspected ADRs (serious/unexpected prioritized), quality defects, or lack of efficacy reported by HCPs, MAHs, or others to NHRA (via forms, email, or channels).
- Timelines: Not rigidly codified in public guidelines (follows general WHO/Arab GVP expectations); **prompt** reporting encouraged for serious/unexpected events. Serious cases prioritized (regional practice often 15 days for serious).
- Reports feed into analysis and potential VigiBase contribution.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions detailed publicly for all products.
- Safety updates may be required during registration renewals, variations, or on request (aligned with basic WHO/ICH formats).

**Risk Management Plans (RMP)**
- Not a standard mandatory requirement for all products.
- May be requested for high-risk/new substances, biologics, or specific concerns (per Arab GVP influence).

**Signal Management and Emerging Safety Issues**
- NHRA conducts surveillance and signal detection.
- MAHs monitor data and notify significant/emerging issues promptly (no fixed 5–45 day timelines publicly specified beyond general promptness).

**Clinical Trials-Related Safety Requirements**
Clinical trials require NHRA approval (via Clinical Trial Committee and application process; aligned with ICH GCP principles).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting required (aligned with international/ICH E2A norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific in approvals).
- No dedicated national electronic system (e.g., no EudraVigilance); reports submitted directly to NHRA (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (ICH E2F or WHO formats), especially for ongoing/multi-country trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to NHRA/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Emphasis on spontaneous reporting, quality surveillance (e.g., traceability/GS1 serialization rules enforced 2025+), counterfeit detection, and public health programs.
- Inspections/audits by NHRA possible (enhanced post-2025 updates); reporting volumes historically low, with improvements via awareness and regional collaboration (e.g., GCC).

Bahrain's PV framework is functional and WHO/Arab GVP-aligned but basic/minimalistic — no stringent MAH obligations like mandatory local QPPV/PSMF/RMP mandates, routine PSUR cycles, or highly detailed timelines compared to more advanced GCC systems (e.g., Kuwait KuGVP 2026, Saudi SFDA GVP). It prioritizes national coordination and spontaneous reporting over complex industry requirements.

For precise, product- or trial-specific details (e.g., current ADR forms, exact timelines, or clinical trial submissions), consult the **National Health Regulatory Authority (NHRA)** directly via nhra.bh (Pharmacy & Pharmaceutical Products Regulation section, guidelines/forms, or contacts), as requirements may evolve with GCC harmonization or national updates. Companies often align with WHO/Arab GVP minimums or reference stricter GCC standards for operations in Bahrain.

• 24*7 Auto Recorded Telephone Number: 17264088 Ext: 401
• Fax: 17264099
• Email: pv@bahrainpharmacy.com
• Po Box: 403, Manama, Bahrain