News

• Exploring regulatory updates and approval requirements for the Qualified Person Responsible for Pharmacovigilance
• Discussing reporting requirements, safety signals, patient support programmes and compassionate use
• Dialogue with customers focuses on clarifying requirements and enhancing readiness for compliance

The Emirates Drug Establishment (EDE) held a virtual Customer Council meeting with partners and sector representatives to introduce key updates to the “Guideline on Controls and Conditions for Good Pharmacovigilance Practices for Medical Products”, outline its implementation requirements and gather participants’ views on related services.

During the meeting, the Establishment highlighted the requirements for approving the Qualified Person Responsible for Pharmacovigilance (QPPV) and their deputy at Marketing Authorisation Holder companies. It also outlined the responsibilities of relevant parties in establishing and maintaining a pharmacovigilance system, overseeing its quality and ensuring compliance with applicable legal and regulatory requirements.

The meeting also examined risk management plans and mechanisms for updating them, the components of the pharmacovigilance system master file and national pharmacovigilance file, and Periodic Safety Update Reports.

Discussions also covered procedures and timelines for reporting adverse reactions in the UAE, including initial and final reports for serious cases, reports of non-serious cases and the approved channels for submitting them to EDE.

Discussions also touched on the management of drug safety signals, from their detection and validation to analysis, assessment and prioritisation, followed by recommendations on the action required.

Participants also highlighted the importance of exchanging information among relevant parties to monitor developments related to product safety and respond to them in a timely manner.

Participants explored pharmacovigilance requirements related to patient support programmes and compassionate use, requirements for healthcare products, as well as post-authorisation safety studies.

The meeting also addressed pharmacovigilance system inspections and the transition period provided to allow relevant entities to align with the updated guideline, review their implementation mechanisms and complete the necessary arrangements in accordance with the new provisions.

The session featured a dialogue with partners and customers on the practical aspects of implementing the guideline, during which EDE heard their questions, feedback and implementation needs. Participants exchanged views on ways to clarify workflows and address potential implementation challenges, helping enhance their readiness for compliance.

The Customer Council was held as part of EDE’s approach to strengthening partnerships with customers and stakeholders and engaging them in discussions on regulatory requirements and their implementation.

This approach supports the development of a more efficient operating environment and an effective pharmacovigilance system, while promoting the safe use of products, enhancing patient safety and protecting public health.