Main Article Content
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.
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
2. Kashte S, Gulbake A, El-Amin SF, Gupta A. COVID-19 vaccines: rapid development, implications, challenges and future prospects. Hum Cell. 2021;34(3):711-733. doi:10.1007/s13577-021-00512-4
3. Pepe VLE, Novaes HMD, Osorio-De-castro CGS. Covid-19 and the medicines regulation challenges in times of pandemic. Cienc e Saude Coletiva. 2021;26(10):4693-4702. doi:10.1590/1413-812320212610.11472021
4. Bolislis WR, de Lucia ML, Dolz F, et al. Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities. Clin Ther. 2021;43(1):124-139. doi:10.1016/j.clinthera.2020.11.015
5. Klein K, Stolk P, Tellner P, Acha V, Montagne S, Stöckert I. Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences? Ther Innov Regul Sci. 2022;56(2):366-377. doi:10.1007/s43441-022-00383-3
6. Darko DAA, Agyekumwaa Boateng O. Regulatory response to pandemics in a developing country- the case of COVID-19 and the Ghana food and drugs authority (Ghana FDA). Int J Drug Regul Aff. 2020;8(4):61-65. doi:10.22270/ijdra.v8i4.438
7. Soumyanarayanan U, Choong M, Leong J, et al. The COVID-19 crisis as an opportunity to strengthen global regulatory coordination for sustained enhanced access to diagnostics and therapeutics. Clin Transl Sci. 2021;14(3):777-780. doi:10.1111/cts.12954
8. Darko DA, Seaneke SK, Sabblah GT, et al. Preliminary findings from stimulated spontaneous reporting of adverse drug reactions during COVID-19 pandemic: An experience from Ghana. Ghana Med J. 2020;54(4):62-70. doi:10.4314/GMJ.V54I4S.10
9. ICMRA. （International Coalition of Medicines Regulatory Authorities） | Pharmaceuticals and Medical Devices Agency. Accessed July 9, 2023. https://www.pmda.go.jp/english/int-activities/int-harmony/icmra/0001.html
10. Nowell LS, Norris JM, White DE, Moules NJ. Thematic Analysis: Striving to Meet the Trustworthiness Criteria. Int J Qual Methods. 2017;16(1):1-13. doi:10.1177/1609406917733847
11. FDA. THE FDA ACHIEVES GLOBAL BENCH-MARKING MATURITY LEVEL 3. Published 2020. Accessed July 24, 2023. https://fdaghana.gov.gh/news-media.php?page=11
12. World Health Organization. Ghana ’ s regulatory system achieves a critical milestone. Published 2020. Accessed July 24, 2023. https://www.who.int/about/accountability/results/who-results-report-2020-mtr/country-story/2020/ghana-s-regulatory-system-achieves-a-critical-milestone
13. Al-Habaibeh A, Watkins M, Waried K, Javareshk MB. Challenges and opportunities of remotely working from home during Covid-19 pandemic. Glob Transitions. 2021;3:99-108. doi:10.1016/j.glt.2021.11.001
14. Lal B, Dwivedi YK, Haag M. Working from Home During Covid-19: Doing and Managing Technology-enabled Social Interaction With Colleagues at a Distance. Inf Syst Front. Published online 2021. doi:10.1007/s10796-021-10182-0
15. September R. A Best Practice Guide for flexible and. 2013;(September 2009):2-14.
16. Josidel Conceição Oliver*, Evandro Neves Silva* LMS, Gislaine Cristina Scodeler, Ana de Souza Santos PPC, Almeida CRP and LA de. Different drug approaches to COVID-19 treatment worldwide: an update of new drugs and drugs repositioning to fight against the novel coronavirus. Ther Adv Vaccines. 2022;10(6):5-10. doi:10.1177/https
17. Shirazi FM, Mirzaei R, Nakhaee S, Nejatian A, Ghafari S, Mehrpour O. Repurposing the drug, ivermectin, in COVID-19: toxicological points of view. Eur J Med Res. 2022;27(1):1-11. doi:10.1186/s40001-022-00645-8
18. Gozzo L, Longo L, Vitale DC, Drago F. The Regulatory Challenges for Drug Repurposing During the Covid-19 Pandemic: The Italian Experience. Front Pharmacol. 2020;11(March):17-20. doi:10.3389/fphar.2020.588132
19. Tran A, Witek TJ. The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic. Pharmaceut Med. 2021;35(4):203-213. doi:10.1007/s40290-021-00397-6
20. Bishnoi M, Sonker A. Emergency use authorization of medicines : History and ethical dilemma. Published online 2023:49-55. doi:10.4103/picr.picr
21. Piszczatoski CR, Powell J. Emergency Authorization of Chloroquine and Hydroxychloroquine for Treatment of COVID-19. Ann Pharmacother. 2020;54(8):827-831. doi:10.1177/1060028020925558
22. Bhimraj A, Morgan RL, Shumaker AH, et al. Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords. Clin Infect Dis. 2022;74(9):1686-1690. doi:10.1093/cid/ciab880
23. Sahoo S, Padhy SK, Ipsita J, Mehra A, Grover S. Demystifying the myths about COVID-19 infection and its societal importance. Asian J Psychiatr. 2020;54. doi:10.1016/j.ajp.2020.102244
24. Mistry SK, Ali ARMM, Yadav UN, et al. Misconceptions about COVID-19 among older Rohingya (forcefully displaced Myanmar nationals) adults in Bangladesh: Findings from a cross-sectional study. BMJ Open. 2021;11(5):1-9. doi:10.1136/bmjopen-2021-050427
25. Al-Rashid M, Al-Hamad A, Al-Hamad A, Yasin Y. Myths, misconceptions, and hesitancy in people residing in Qatar toward mRNA COVID-19 vaccines: An experience exchange from Qatar University health center. Qatar Med J. 2022;2022(2):19-21. doi:10.5339/qmj.2022.fqac.20
26. Tabong PTN, Segtub M. Misconceptions, Misinformation and Politics of COVID-19 on Social Media: A Multi-Level Analysis in Ghana. Front Commun. 2021;6(May):1-13. doi:10.3389/fcomm.2021.613794
27. Ministry of Health. PRESIDENT AKUFO-ADDO COMMISSIONS NATIONAL VACCINE INSTITUTE - Ministry Of Health. Accessed July 24, 2023. https://www.moh.gov.gh/president-akufo-addo-commissions-national-vaccine-institute/