EDE Customer Council Discusses Implementation of Good Pharmacovigilance Practices Guideline

The Emirates Drug Establishment (EDE) held a virtual Customer Council meeting with partners and industry representatives to present updates to the Guideline on Controls and Conditions for Good Pharmacovigilance Practices for Medical Products, discuss implementation requirements, and gather feedback on related services.

Key Pharmacovigilance Requirements Discussed

The meeting covered the requirements for approving the Qualified Person Responsible for Pharmacovigilance (QPPV) and deputy QPPV at Marketing Authorisation Holder (MAH) companies. EDE also addressed the responsibilities of relevant parties in establishing and maintaining pharmacovigilance systems, overseeing their quality, and ensuring regulatory compliance.

Other topics included:

• Risk management plans and mechanisms for updating them.
• The contents of the Pharmacovigilance System Master File (PSMF) and the national pharmacovigilance file.
• Periodic Safety Update Reports (PSURs).
• Procedures and timelines for reporting adverse reactions in the UAE, including initial and final reports for serious cases, reports for non-serious cases, and approved submission channels to EDE.

Safety Signal Management and Other Requirements

The discussions also addressed safety signal management, including signal detection, validation, analysis, assessment, and prioritisation, followed by recommendations for appropriate action.

Participants discussed the importance of information exchange among relevant parties in monitoring developments related to product safety and responding to emerging concerns.

Additional topics included pharmacovigilance requirements for patient support programmes, compassionate use, healthcare products, and post-authorisation safety studies.

Pharmacovigilance Inspections and Transition Period

EDE also discussed pharmacovigilance system inspections and the transition period available to relevant entities to align their systems and procedures with the updated guideline.

The meeting provided an opportunity for partners and customers to raise questions and share feedback on practical implementation, including clarifying workflows and addressing potential challenges to compliance readiness.

Pharmacovigilance Services

The requirements discussed at the meeting cover several areas of pharmacovigilance system management. Baupharma’s Pharmacovigilance Services include related activities such as safety reporting, pharmacovigilance documentation, and signal management.

Conclusion

EDE’s Customer Council meeting focused on implementing the updated Good Pharmacovigilance Practices Guideline for Medical Products. Discussions covered QPPV approval, pharmacovigilance documentation, adverse reaction reporting, risk management, safety signal management, post-authorisation safety studies, inspections, and the transition period.

The meeting also enabled EDE to gather stakeholder feedback on the practical application of the updated requirements.

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