EDE Updates Pharmacovigilance Guidelines with Industry Partners
The Emirates Drug Establishment convenes sector representatives to review enhanced safety protocols and implementation requirements for medical products across the UAE.
The Emirates Drug Establishment held a comprehensive virtual meeting with industry partners and sector representatives on 7th October to introduce significant updates to its Guideline on Controls and Conditions for Good Pharmacovigilance Practices for Medical Products. The session provided an opportunity to outline implementation requirements and gather valuable feedback from stakeholders across the pharmaceutical sector.
A central focus of the meeting was the approval framework for Qualified Persons Responsible for Pharmacovigilance and their deputies within Marketing Authorisation Holder companies. The EDE emphasised the critical responsibilities incumbent upon all relevant parties in establishing, maintaining and overseeing the quality of pharmacovigilance systems whilst ensuring full regulatory compliance.
The updated guideline addresses several key operational areas. Attendees reviewed risk management plans and the procedures for updating them, alongside the essential components of both the pharmacovigilance system master file and the national pharmacovigilance file. Periodic Safety Update Reports were also examined in detail.
Particular attention was directed towards the UAE’s adverse reaction reporting procedures and timelines. The guideline clarifies protocols for initial and final reports concerning serious cases, reporting mechanisms for non-serious cases, and the approved channels through which all submissions must be directed to the EDE. These standardised procedures ensure consistent and efficient safety monitoring across the healthcare sector.
The meeting further addressed specialised pharmacovigilance requirements applicable to patient support programmes, compassionate use initiatives and healthcare products, alongside requirements for post-authorisation safety studies. The EDE outlined inspection procedures for pharmacovigilance systems and confirmed a transition period during which relevant entities must align their existing systems and procedures with the updated guideline.
Throughout the discussion, the EDE welcomed questions and practical feedback from partners and customers regarding implementation of the guideline. Participants raised concerns about workflow clarification and potential challenges in achieving compliance, fostering a collaborative dialogue to identify solutions and ensure sector readiness for the new framework.
Source: WAM