According to Resolution No. (27) of 2026, published by the Emirates Drug Establishment (EDE) on 27 July 2026, EDE has approved a new Pharmacovigilance Practice Guideline for Medical Products.

🔍 What’s New

The guideline provides a structured pharmacovigilance framework for companies responsible for medical products in the UAE, covering safety governance, adverse-event monitoring and reporting, local pharmacovigilance responsibilities, and the appointment of qualified pharmacovigilance personnel.

The guideline applies to:

• Pharmaceutical products
• Healthcare products
• Dietary supplements
• Cosmetic products with a medical effect

Marketing Authorization Holders must establish and maintain an effective pharmacovigilance system and appoint both a Qualified Person for Pharmacovigilance (QPPV) and a deputy.

The QPPV and deputy must:

• Hold at least a bachelor’s degree in pharmacy or medicine
• Have sufficient theoretical and practical pharmacovigilance knowledge and training
• Understand UAE pharmacovigilance legislation
• Be residents of the UAE

Where a foreign Marketing Authorization Holder does not have a licensed marketing office in the UAE, the qualified person may work through the licensed medical warehouse appointed to perform the regulatory activities.

💡 Why it Matters

The guideline establishes clear local requirements for pharmacovigilance governance, adverse-event reporting, risk management, safety documentation, and QPPV oversight.

Companies should assess whether their current UAE pharmacovigilance structure, responsible personnel, SOPs, reporting processes and timeline, and local safety files comply with the new requirements.

📌 How ReguLinked Can Support

ReguLinked can support with:

• Pharmacovigilance compliance gap assessments
• Safety-reporting process reviews
• SOP and pharmacovigilance system readiness

Planning to assess the impact of the new UAE pharmacovigilance guideline on your operations?

Let ReguLinked support your regulatory readiness with a fully EDE-aligned pharmacovigilance strategy.

“Book your complimentary consultation today”

📧 bd@regulinked.com | 🌐 www.regulinked.com

📎 Official guideline— Arabic Only:
EDE Pharmacovigilance Practice Guideline