Regulatory response to pandemics in a developing country- the case of COVID-19 and the Ghana food and drugs authority (Ghana FDA)

Abstract

The emergence of the novel coronavirus (COVID-19) has demonstrated the challenge of a single infection to health systems across the globe. The World Health Organization (WHO) declared COVID-19 as a pandemic on 11th March 2020, pointing at the time to the over 118,000 cases of the coronavirus illness in over 110 countries around the world and the sustained risk of further global spread. Congruent to this declaration by the WHO, countries were expected to accelerate their individual efforts amidst striking the right balance between protecting health and preventing economic or social disruption. In response to the pandemic, regulatory authorities of food and drugs in various countries are also recognizing the new demands and obligations that the pandemic has brought and taking measures to meet them and provide the much-needed support. The Ghana Food and Drugs Authority (FDA) has taken various accelerated actions to meet the local demands in managing COVID-19. The regulatory interventions not only aim to facilitate the authorization of medicines and health technologies, sensitize the public on disease prevention and ensure the uninterrupted availability of medical and food supplies but also seek to inspire and boost local industrial potential. The Ghana FDA’s efforts are multifaceted and include propping the Drug Supply Chain, expeditious testing of essential COVID-19 medicines, facilitating efforts at COVID-19 test kit evaluation, active post market surveillance and public sensitization on preventive measures. The outcomes of the FDA response have informed ample opportunities that can be leveraged on now and beyond the pandemic and sensitized the Authority on the need to simulate possible emergencies and be better prepared in future happenings.

Covid-19 Pandemic and Medicines Regulation in Ghana: Overview and Perspectives of Regulators

“…Regulatory adaptations included accelerated assessment processes, reliance on data from wellestablished regulatory authorities, and increased collaboration among stakeholders. Emergency use authorization (EUA) pathways for registration were also established and implemented to expedite the availability of COVID-19 diagnostic tests, therapeutics, and vaccines, making them available for use sooner than they would normally have with traditional regulatory processes 3,6 .…”