UAE

UAE

Medwisdom Lifescience delivers comprehensive, MOHAP-compliant pharmacovigilance services for the UAE market — including resident QPPV support, ADR reporting, PSUR/PBRER submissions, RMP development, and medical device vigilance under the new Federal Decree-Law No. 38 of 2024.

Overview

Pharmacovigilance (PV) in the UAE is regulated by the Ministry of Health and Prevention (MOHAP) through its Pharmacovigilance and Drug Information Department, in alignment with ICH, GVP, and the new Federal Decree-Law No. 38 of 2024 effective January 2025. This framework ensures robust post-marketing surveillance for drugs and medical devices, emphasizing patient safety amid the UAE's growing pharmaceutical market projected to reach AED 21.74 billion by 2025.

All Marketing Authorization Holders (MAHs) must maintain a UAE-specific PV system, appoint a resident Qualified Person for Pharmacovigilance (QPPV), and report safety data via digital portals, supporting innovation while upholding global standards.

Pharmacovigilance Requirements & Approval Timelines

Drug registration in the UAE, incorporating PV plans like PSMF and RMP, typically takes 12-18 months via eCTD submissions, with faster reliance pathways (3-6 months) for innovative therapies. Renewals occur every 5-10 years. Medical devices, classified I-IV under risk-based rules, require 6-12 months for approval, with a one-year transition under the 2025 law.

• Regulatory Authority
  MOHAP's Registration and Drug Control Department (DCD) oversees PV for drugs; Emirates Drug Establishment (EDE) handles testing and oversight since 2023
• PV for Drugs
  MAHs must submit National PV File, SOPs, and monitor ADRs; bilingual labeling (Arabic/English) with GS1 barcodes mandatory
• PV for Medical Devices
  Risk-based vigilance reporting via electronic systems; includes field safety corrective actions (FSCA), trend analysis, and linkage to UDI/EUDAMED

Challenges in UAE Pharmacovigilance

The UAE's PV system, while advanced, faces hurdles like underreporting of ADRs (only 19% of professionals have reported), limited awareness, and resource shortages in hospitals. The transition to the 2025 law adds compliance complexities for digital submissions and QMS alignment (e.g., ISO 13485).

• Underreporting due to lack of training and awareness among HCPs
• Shortage of clinical pharmacists and inconsistent ADR causality assessment
• Integration challenges with new electronic portals and bilingual requirements
• Policy ambiguities during the 2025 regulatory transition period

Medwisdom mitigates these with expert training, automated tools, and seamless MOHAP/EDE navigation for uninterrupted compliance.

Our Pharmacovigilance Services for UAE

Why Choose Medwisdom for UAE Pharmacovigilance

• UAE-Specific Expertise
  Proven success with MOHAP approvals and EDE oversight, accelerating 12-18 month timelines
• Resident QPPV & Local Support
  Certified professionals addressing underreporting and training gaps
• End-to-End Compliance
  From eCTD registration to 2025 law transitions for drugs and devices
• Risk Mitigation Tools
  Automated digital submissions and audits to overcome resource challenges
• Innovation Focus
  Support for biologics, biosimilars, and reliance pathways
• 24/7 Vigilance
  Rapid response ensuring patient safety and regulatory harmony

Tentative PV Reporting Timelines in UAE (GVP-Aligned)