By Jones Anlimah
The Food and Drugs Authority (FDA) has highlighted Ghana’s comprehensive regulatory framework for vaccines, reaffirming its readiness to safeguard public health as the country advances toward local vaccine production. This was shared at a workshop on vaccine communication and advocacy organised by the National Vaccine Institute (NVI) in Accra.
Delivering a presentation on “Understanding the Local Regulatory Environment,” the Acting Director for the Clinical Trials Department of the FDA, Pharm. Patrick Owusu-Danso, underscored the Authority’s mandate as Ghana’s national regulatory body responsible for ensuring the safety, quality and efficacy of human and veterinary drugs, vaccines, biological products, medical devices, food, cosmetics, and the conduct of clinical trials.
He outlined the FDA’s mission to protect public health through strict enforcement of standards and its vision to remain a global centre of excellence in food and medical product regulation. Pharm. Owusu-Danso emphasised that vaccine regulation is anchored on core values such as integrity, accountability, teamwork, and strict adherence to quality and safety benchmarks.
According to him, the regulatory functions for vaccines include pre–and post–market surveillance, clinical trials oversight, laboratory testing, regulatory inspections, and vigilance systems designed to detect and respond to safety concerns. These functions ensure that every vaccine used in Ghana meets acceptable standards of identity, purity, safety, quality, and efficacy.
He further highlighted Ghana’s alignment with major international regulatory standards, including WHO Guidelines, ICH guidelines, FDA Ghana guidelines, United States Pharmacopeia, European Pharmacopoeia, and other globally validated methods.
The presentation also noted that the FDA collaborates with several global and continental institutions such as the World Health Organization, African Medicines Agency, African CDC, Paul Ehrlich Institute, and the Network of African Vaccine Regulatory Authorities to strengthen regulatory systems and harmonise standards across countries.
Pharm. Owusu-Danso stressed that vaccine regulation in Ghana is built on stringent systems designed to assure safety, quality, and efficacy. He said the FDA remains one of Africa’s most reliable regulators, mandated by law and backed by strong technical capacity to support Ghana’s move toward vaccine self-sufficiency.
