Skip to main content
2024 ISPE Annual Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

BRACE, health policy, guidance documents

Session: Poster Session C

(031) Proactive Safety Monitoring of Recent Registered Medicinal Products in Saudi Arabia: the SFDA Experience

Wednesday, August 28, 2024
8:00 AM – 1:30 PM CEST
Location: Convention Hall II

    Presenting Author(s)

  • Fawaz Alharbi, MSc, PhD

    Director Of Drug Safety and Risk Management
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

    • Co-Author(s)

  • NA

    Nora S. Alorf

    Saudi Food & Drug Authority, Saudi Arabia

  • HA

    Hadir Aljohani, Master degree in clinical pharmacy

    drug safety expert
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Saudi Arabia

  • WA

    Waad Alghamdi

    Saudi Food and Drug Authority
    Riyadh, Saudi Arabia

  • LA

    Lama Alhusayni

    SFDA, Saudi Arabia

  • SA

    Solaiman Alhawas

    Saudi Food & Drug Authority (SFDA), Saudi Arabia

  • FA

    Fares Alrubaish

    Saudi Food and Drug Authority, Saudi Arabia

  • SA

    Sara AlMeshari

    SFDA, Saudi Arabia

  • NA

    Nouf Al-Fadel, MSc. Clin

    Head of Pharmacoepidemiology Section
    Drug Safety and Risk Management department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
    Riyadh, Saudi Arabia

Background: Saudi Food and Drug Authority (SFDA) established the Proactive Drug Safety Monitoring Program in 2019 to monitor the safety of registered medicinal products in Saudi Arabia more proactively and efficiently.

Objectives: To evaluated the relatedness of adverse drug event (ADE) case reports exported from VigiBase, the World Health Organization global database of individual case safety reports (ICSRs), with a group of medicinal products approved by the SFDA.

Methods: Annually, a list of recent registered medicinal products by the SFDA is identified. The most common pharmacological categories of selected medicines were monoclonal antibodies, antineoplastic agents, vaccines, and immunomodulatory agents. Then, the ADE case reports of the selected medicines were retrieved from VigiBase and AdisInsight database. After that, labelness assessment of the retrieved ADEs for each medicine was performed by crosschecking the label information of the United States Food and Drug Administration, European Medicines Agency and the SFDA to exclude the labeled ADEs. Finally, a comprehensive drug safety review for the potential signals was performed using different evidence sources including unpublished clinical trials, literature, local and global ICSRs and regulatory documents.

Results: Up to the end of 2023, 371 registered medicines were selected for primary screening [ in 2019 (n=67), 2020 (n=120), 2021(n=110), 2022(n=44) and 2023 (n=30)]. The labelness assessment resulted in requesting of label update for 194 medicines (52.3 %). A total of 224 comprehensive drug safety reviews were performed for 582 potential safety signals. The safety review recommendations were requesting label update (N=21 signals), requesting additional safety data from pharmaceutical companies (n=81 signals), keeping routine monitoring of the risk (n=283 signals) and refuted signals (n=197 signals).

Conclusions: The Proactive Drug Safety Monitoring Program in the SFDA successfully improved the identification of new safety information for medicinal products.