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

Abstract

Background: The novel coronavirus SARS-CoV-2 pandemic, impacted health systems around the world resulting in a surge in demand for medicines and therapeutic interventions to combat the pandemic. Medicine regulatory agencies played a crucial role in ensuring the safety, quality, and efficacy of medicines. Regulatory agencies streamlined regulatory processes and made them flexible to tackle the urgent need for COVID-19 interventions. The COVID-19 pandemic prompted regulatory agencies on the importance of global regulatory collaboration and harmonization. Following the pandemic, regulatory agencies continually aim to ensure global alignment in regulatory standards, facilitate data sharing, and streamline regulatory processes to optimize their activities and preparedness for future emergencies. Objective: The objective of this study was to have an overview of medicines regulation following the emergence of the COVID-19 pandemic and regulator’s perspective on the associated regulatory adaptations. Method: The study was conducted through qualitative open-ended interviews. It was carried out within the head office of the Ghana Food and Drugs Authority; the sole regulator of medicines in the country. Interviews were audio-recorded with the consent of participants and transcribed for analysis. After transcription data was categorized into themes and analyzed using a generic thematic analysis method. Results: Ghana's medicines regulatory system, governed by the Food and Drugs Authority (FDA) developed a system which encompassed pre-market approval, post-market surveillance, pharmacovigilance activities, and approval of clinical trials, aimed at safeguarding public health. To address the urgent need for COVID-19 treatments and vaccines, regulators worldwide, including Ghana, implemented emergency use authorization (EUA) processes, demonstrated regulatory flexibility by adopting alternative assessment approaches and streamlining processes without compromising safety and quality standards. The Food and Drugs Authority along with other stakeholders and opinion leaders played a crucial role in disseminating accurate information and debunking myths and misconceptions about the pandemic to empower citizens with accurate information, dispel misinformation, and promote adherence to preventive measures. Conclusion: The importance of resourcefulness and the adoption of sustainable practices, working smarter, saving resources, embracing virtual trainings, and introducing dynamic assessment practices have been highlighted to have reshaped activities of the Authority. These lessons can serve as valuable guides in building a more efficient, collaborative, and environmentally conscious future as we continue to navigate the post pandemic world.