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  • Ghana's COVID-19 Safety Monitoring Effects Receive Global Acclaim

    Ghana s efforts in monitoring and reporting on the safety of COVID-19 has been recognized globally. At the 22nd Annual Conference of the International Society of Pharmacovigilance (ISoP) in Bali, Indonesia in November 2023, the Ghana Food and Drug Authority's SafetyWatch database was praised for contributing 15% of the safety reports on COVID-19 in Africa.

    The contribution from Ghana and the active work undertaken by the safety monitoring teams from Ethiopia, Ghana, Kenya, Nigeria and South Africa led the African team to win the inaugural Sten Olsson Award at ISoP 2023. The African team is the main body of the African Union's Smart Safety Surveillance (AU-3S) programme which is designed to provide a robust safety monitoring platform for Africa.

    The AU-3S programme is funded by the Bill and Melinda Gates Foundation (BMGF) whilst the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) serves as a crucial technical partner to develop and deploy traditional and digital solutions to enhance the safety monitoring of essential medical products throughout Africa as its overarching objective. The Ghana FDA has for over 20 years had a bilateral relationship with the UK MHRA and this has allowed the FDA to develop and use SafetyWatch System since 2016.

    During the COVID-19 pandemic, the Ghana FDA established a Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) made up of experts from public health, teaching hospitals, academia, regulatory authorities and the Expanded Programme on Immunization (EPI). This Committee met in-person regularly to review all safety reports to COVID-19 vaccines. The outcomes of these meetings were communicated to the country by way of COVID-19 updates from the FDA. Additionally, the Chairman of the Ghana JCVSRC joined the African Union's AU-3S Joint Signal Management (JSM) Group to review and evaluate safety data associated with COVID-19 vaccines.

    The data for the award-winning poster was sourced from the founding countries, namely Ghana, Ethiopia, Nigeria, South Africa and Kenya.
    The Chairman of the JCVSRC, Professor John Gyapong, was delighted at the news and expressed his gratitude to members of the committee in Ghana for their dedication and commitment to see the AU-3S program succeed. He also congratulated the AU-3S team and experts from the five founding member countries who are part of the JSM Group for their contributions to the prestigious award and looked forward to the AU-3S program becoming a robust pharmacovigilance platform, which will strengthen safety monitoring of health products in Africa.

    The award also signifies global recognition for the AU-3S objective of monitoring the safety of essential medical products across Africa, which will significantly enhance patient safety.

    The CEO of the FDA, Dr. Delese Darko, commenting on the award, congratulated members of the FDA's Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) for their diligence and hard work that saw the team in Ghana make such a contribution towards winning such a prestigious award and most importantly for dedicating their time to ensuring patient and vaccine safety in Ghana and on the continent of Africa as a whole.


    The FDA exist to ensure the safety, quality and efficacy of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances and clinical trials, and the control of tobacco products through the enforcement of relevant standards to protect public health.

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