Quote from VigiServe Admin on November 28, 2020, 8:41 AM

✅ **Pharmacovigilance Requirements in Kuwait (as of January 2026)**

https://youtu.be/i-dkvLXlHlI

Kuwait’s PV system is governed by the **Kuwait Good Pharmacovigilance Practice Guidelines (KuGVP)**, Version 6 (January 2026), issued by the **Kuwait Pharmacovigilance Center (KPVC)** under the **Drug and Food Control Sector**, Ministry of Health. The KuGVP is legally binding and closely aligned with EU GVP, ICH, and Arab GVP guidelines.

### Key Contact Information
- **Reporting email**: adr_reporting@moh.gov.kw
- **General enquiries**: pv-info@moh.gov.kw
- **Tel**: +965 24611676 (WhatsApp)

### Legal Framework and Governance
- KuGVP Version 6 (January 2026) is the primary binding guideline.
- KPVC is the national pharmacovigilance center responsible for ADR collection, signal detection, risk assessment, inspections, alerts, and VigiBase contributions (via VigiFlow).
- Risk-based GVP inspections are conducted by authorities.

### Organization and Personnel
- **Marketing Authorization Holders (MAHs)** must establish and maintain a full pharmacovigilance system.
- **Qualified Person Responsible for Pharmacovigilance (QPPV)**: Mandatory; must be a qualified professional (physician or pharmacist with PV experience) resident in Kuwait, registered with authorities, and serve as the 24/7 primary contact.
- **Local Safety Responsible Person (LSR)**: Mandatory for local agents/representatives; handles local PV activities and reporting.
- **Pharmacovigilance System Master File (PSMF)** and **Local Pharmacovigilance Sub-System Master File (PSSMF)**: Both required. PSMF must be maintained, updated, and available for inspection (detailed content and format specified in Module 7).

### Individual Case Safety Reports (ICSRs) – Post-Marketing
- Report all suspected ADRs, quality defects, and lack of efficacy to KPVC.
- **Timelines** (standard ICH-aligned):
- Serious ICSRs (including fatal/life-threatening): **15 calendar days**.
- Non-serious ICSRs: **90 calendar days**.
- Use official forms: Suspected ADR form, Quality Defect form, Vaccine AEFI form.
- Coding uses MedDRA; reports feed into VigiFlow/VigiBase.

### Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)
- Required per Module 10.
- Submitted in full ICH E2C(R2) modular format.
- Frequency: As specified in the marketing authorization or on request (typically 6-monthly initially, then annual).

### Risk Management Plans (RMP)
- Required for new applications, high-risk products, biologics, biosimilars, and generics (in specific cases).
- EU-style structure (Parts I–VII) mandatory.
- National display/annex required if an EU RMP exists.
- Updates required for new risks or significant changes.

### Signal Management
- MAHs and KPVC share responsibilities for signal detection, validation, prioritization, assessment, and escalation (detailed process in Module 11).
- MAHs must continuously monitor global and local data.

### Clinical Trials-Related Safety Requirements (Module 15)
- Sponsors must report safety data from clinical trials conducted in Kuwait.
- **SUSARs**:
- Fatal or life-threatening SUSARs: **7 calendar days**.
- All other serious unexpected SUSARs: **15 calendar days**.
- Minimum reporting criteria and data elements specified.
- **Development Safety Update Reports (DSURs)**: Annual submission required.
- Blinded therapy cases and post-study events have specific handling rules.
- Reports submitted to KPVC.

### Additional Aspects
- **Inspections & Audits** (Module 8): Risk-based, routine, for-cause, announced/unannounced, remote possible.
- **Vaccine Safety** (Module 16): Dedicated AEFI surveillance, investigation, causality assessment, and communication guidelines.
- **Biopharmaceuticals** (Module 14): Special emphasis on traceability, immunogenicity, interchangeability, and biosimilars.
- **Safety Communication** (Module 12): Direct HCP communication (DHPC), media, public alerts.
- **PASS/PAES** (Module 13): Required when imposed or voluntary.

Kuwait’s PV system became significantly more structured and enforceable with the January 2026 KuGVP release (mandatory QPPV/LSR registration, PSMF/PSSMF, detailed RMP and inspection requirements). It is now one of the most detailed frameworks in the GCC.

For the full official document and latest forms, refer to the Ministry of Health / KPVC website or request directly from adr_reporting@moh.gov.kw or pv-info@moh.gov.kw.