DUBAI, 7th October, 2026 (WAM) -- 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 implementation requirements and gather feedback on related services.
EDE highlighted requirements for approving the Qualified Person Responsible for Pharmacovigilance (QPPV) and their deputy at Marketing Authorisation Holder companies, as well as the responsibilities of relevant parties in establishing and maintaining pharmacovigilance systems, overseeing their quality and ensuring regulatory compliance.
The meeting reviewed 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.
It 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 approved channels for submitting them to EDE.
Other topics included pharmacovigilance requirements for patient support programmes, compassionate use and healthcare products, as well as post-authorisation safety studies.
The meeting also addressed pharmacovigilance system inspections and the transition period for relevant entities to align their systems and procedures with the updated guideline.
EDE also heard questions and feedback from partners and customers on the practical application of the guideline, including ways to clarify workflows and address potential challenges to ensure readiness for compliance.