KUWAIT

KUWAIT

Medwisdom Lifescience offers expert, GCC-aligned pharmacovigilance services for Kuwait, ensuring full compliance with Ministry of Health (MOH) requirements. From local PV officer support and ADR reporting to PSUR/PBRER submissions, RMP development, and medical device vigilance, we help safeguard patient safety while streamlining your regulatory journey.

Overview

Pharmacovigilance (PV) in Kuwait is overseen by the Ministry of Health (MOH) through the Drug and Food Control Administration (DFCA), with the dedicated Pharmacovigilance Office established under Ministerial Decision No. 382/2023. As a GCC member, Kuwait adheres to the unified GCC Pharmacovigilance Guidelines, emphasizing proactive monitoring of adverse drug reactions (ADRs) and device incidents to protect public health.

All Marketing Authorization Holders (MAHs) must appoint a local PV responsible person, maintain a Pharmacovigilance System Master File (PSMF), and report safety data promptly. This structured approach supports both drug and medical device safety, aligning with international standards like ICH and WHO.

Pharmacovigilance Requirements & Approval Timelines

Drug registration in Kuwait, which integrates PV elements like PSMF submission, typically takes 6-8 months from dossier submission to approval via the eCTD format. Certificates are valid for 5 years, with renewals required 6 months prior. Medical devices follow a similar process, classified into Classes A-D, with registration approvals in 2-6 months.

• Regulatory Authority
  The MOH's DFCA manages PV for drugs, while the Pharmacovigilance Office (under Kuwait Office for Pharmacovigilance Surveillance - KOPS) handles oversight and reporting. GCC guidelines provide the harmonized framework.
• PV for Drugs
  MAHs must establish a local PV system, including SOPs, safety database, and 24/7 contact for ADRs. Literature monitoring and signal detection are mandatory.
• PV for Medical Devices
  Incident reporting via the MOH's Medical Device Incident Report form; post-market surveillance includes field safety corrective actions (FSCA) and traceability, aligned with global standards.

Challenges in Kuwait Pharmacovigilance

While Kuwait's PV system is evolving, key challenges include underreporting of ADRs due to limited awareness among healthcare professionals, difficulties in causality assessment, and policy ambiguities from nascent regulations. Resource constraints and the need for stronger integration with GCC systems can delay compliance, but partnering with experienced providers mitigates these effectively.

• Low ADR reporting rates (e.g., only 16.58 reports/100,000 population)
• Lack of dedicated PV legislation, leading to inconsistent practices
• Human resource shortages and training gaps in signal detection
• Coordination hurdles between local agents, MAHs, and MOH/KOPS

Medwisdom addresses these head-on with tailored training, automated reporting tools, and proven GCC expertise for seamless navigation.

Our Pharmacovigilance Services for Kuwait

Why Choose Medwisdom for Kuwait Pharmacovigilance

• Deep GCC & Kuwait Expertise
  Proven track record with MOH/DFCA submissions and KOPS updates, ensuring zero delays
• Local Presence & Compliance
  Dedicated PV officers and automated tools to overcome underreporting challenges
• End-to-End Solutions
  From registration (6-8 months) to ongoing vigilance for drugs and devices
• Risk Mitigation
  Proactive training and audits to address causality and policy gaps
• Patient-Centric Focus
  Enhancing safety while accelerating market access for your portfolio
• 24/7 Support
  Rapid response for emergencies, with transparent reporting

Tentative PV Reporting Timelines in Kuwait (GCC-Aligned)