Emirates Drug Establishment Launches National Programme For Pharmacovigilance Inspection Practices

The Emirates Drug Establishment (EDE) has initiated a workshop focused on pharmacovigilance inspection. This programme, in partnership with the pharmaceutical sector, aims to enhance national skills for evaluating pharmacovigilance systems in pharmaceutical companies. It seeks to create a proactive regulatory framework centred on risk detection and analysis, ensuring medication safety and healthcare quality in the UAE.

The workshop marks the first collaboration between EDE and the pharmaceutical sector in pharmacovigilance inspection, with support from Sanofi. It aims to bolster inspection readiness and introduce modern regulatory frameworks. The initiative is part of EDE's strategy to develop an advanced regulatory framework, strengthen medication safety, and protect patients by building specialised national capabilities.

This two-day event explored practical expertise transfer in inspecting pharmacovigilance practices. Participants were trained on the complete inspection cycle, including pre-inspection planning, documentation requirements, field procedures, and report preparation. The workshop reflects a partnership aimed at accelerating medication-safety initiatives and enhancing transparency in pharmaceutical regulation based on data and scientific evidence.

Dr. Fatima Al Kaabi, Director-General of EDE, stated that the national programme for inspecting pharmacovigilance practices supports EDE’s strategy to build an integrated regulatory system prioritising patient safety through effective partnerships with the pharmaceutical sector. She emphasised EDE's commitment to developing a leading oversight system driven by national competencies capable of leading this transformation.

Al Kaabi highlighted that this initiative aligns with EDE's strategy to advance the health and pharmaceutical sector within flexible regulatory frameworks supporting innovation and trust in healthcare. EDE is exploring expanding this initiative to include advanced inspection programmes, updated guidelines for pharmacovigilance practices, and integrating outcomes into digital systems for evidence-based decision-making.

Preeti Futnani, MCO Lead & General Manager for Sanofi Specialty Care, GCC, expressed pride in supporting EDE through official collaboration between regulatory authorities and the pharmaceutical sector. She noted that the UAE has a clear vision for regulatory development and emphasised Sanofi's commitment to contributing global expertise. Futnani stated that "Pharmacovigilance is a shared responsibility," highlighting the importance of building strong systems together to enhance trust and elevate care quality.

This initiative represents a significant step towards establishing a sustainable model for medication safety and quality of life in the UAE. By fostering collaboration between regulatory bodies and the pharmaceutical industry, it aims to ensure continued advancements in healthcare standards while maintaining patient safety as a top priority.

With inputs from WAM