Higher Pharmacovigilance Advisory Committee

Higher Pharmacovigilance Advisory Committee


In accordance with the Saudi Food and Drug Authority law issued by Royal decree (م / 6) on 25/1/1425H, and its implemented regulation issued by the authority’s board of directors number 7-7-1428 on 25/7/1429H which include the minister’s decision to create A Higher Pharmacovigilance Advisory Committee. The Committee carries the following tasks:

    1. Review and evaluate the safety or benefit/risk review reports of pharmaceutical products referred to the committee.
    2. Issuing recommendations and expressing opinions on urgent issues referred to the committee regarding safety and efficacy of pharmaceutical products.
    3. Review the implementation of risk minimization measures of pharmaceutical products in the Kingdom of Saudi Arabia and the studies prepared for its evaluation referred to the committee.
    4. Review and evaluate of protocols for post authorization safety studies referred to the committee