Comparison of Three Regional Medicines Regulatory Harmonisation Initiatives in Africa: Opportunities for Improvement and Alignment

Document Type : Original Article

Authors

1 School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK

2 African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), Johannesburg, South Africa

3 Food and Drug Authority Ghana, Accra, Ghana

4 Centre for Innovation in Regulatory Science, London, UK

5 Institute for Medicines Development, Hatfield, UK

Abstract

Background 
The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa MRH, and the Economic Community of West Africa States MRH) were established. As these initiatives serve as a foundation for the African Medicines Agency (AMA), the aim of this study was to compare their operating models, successes and challenges to identify opportunities for improvement and alignment.
 
Methods 
A mixed method approach was used for the data collection using a questionnaire, the Process, Effectiveness and Efficiency Rating (PEER), developed by the authors specifically for this study and semi-structured interview techniques. There were 23 study participants (one from each agency of the member countries of the three regions). It was hoped that data generated from this study would lead to a series of recommendations, which would then be ratified by the regulatory authorities.
 
Results 
Most respondents stated that AMRH contributed to the strengthening of regulatory systems and harmonising regulatory requirements across economic regions of Africa, potentially resulting in improved access to quality-assured medicines. Although established at different times and at the discretion of each region, the marketing authorisation application review processes are largely similar, with a few differences noted in the eligibility and submission requirements, type of procedures employed, the timelines and fees payable. The challenges identified in the three regions are also similar, with the most noteworthy being the lack of a binding legal framework for regional approvals.
 
Conclusion 
In this study, we compared the process, successes and challenges of these three regional harmonisation initiatives in Africa addressing the areas of legal frameworks, information management systems, the accessibility and affordability of medicines and reliance that will bring greater alignment and efficiency in their operating models, thereby strengthening the foundation of the soon-to-be-operationalised AMA.

Keywords


  1. Rägo L, Santoso B. Drug regulation: history, present and future. In: van Boxtel CJ, Santoso B, Edwards IR, eds. Drug Benefits and Risks: International Textbook of Clinical Pharmacology. 2nd ed. Uppsala: IOS Press, Uppsala Monitoring Centre; 2008.
  2. European Medicines Agency. EMA Starts First Rolling Review of a COVID-19 Vaccine in the EU. Available at: https://www.ema.europa.eu/en/news/ema-starts-first-rolling-review-covid-19-vaccine-eu. Accessed January 30, 2024.
  3. World Health Organization (WHO). TRS 1033 - Annex 10: Good Reliance Practices in the Regulation of Medical Products: High Level Principles and Considerations. WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty-Fifth Report. WHO; 2021:237-267.
  4. World Health Organization (WHO). Essential medicines and health products. WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory Systems. 2021 Available at: https://www.who.int/tools/global-benchmarking-tools/VI. Accessed January 30, 2024.
  5. McAuslane N, Bujar M, Sithole T, Ngum N, Owusu-Asante M, Walker S. Evaluation of risk-based approaches to the registration of medicines: current status among African regulatory authorities. Pharmaceut Med. 2023;37(3):251-260. doi:1007/s40290-023-00472-0
  6. Ndomondo-Sigonda M, Miot J, Naidoo S, Ambali A, Dodoo A, Mkandawire H. The African Medicines Regulatory Harmonization Initiative: progress to date. Med Res Arch. 2018;6(2):1-15. doi:18103/mra.v6i2.1668
  7. Sillo H, Ambali A, Azatyan S, et al. Coming together to improve access to medicines: the genesis of the East African Community's Medicines Regulatory Harmonization initiative. PLoS Med. 2020;17(8):e1003133. doi:1371/journal.pmed.1003133
  8. Ngum N, Mashingia J, Ndomondo-Sigonda M, Walker S, Salek S. Evaluation of the effectiveness and efficiency of the East African Community joint assessment procedure by member countries: the way forward. Front Pharmacol. 2022;13:891506. doi:3389/fphar.2022.891506
  9. World Health Organization (WHO). Tanzania Food and Drug Authority Becomes the First to Reach Level 3 of the WHO Benchmarking Programme. WHO; 2018 Available at: https://www.afro.who.int/news/tanzania-food-and-drug-authority-becomes-first-reach-level-3-who-benchmarking-programme. Accessed January 30, 2024.
  10. Sithole T, Mahlangu G, Salek S, Walker S. Evaluating the success of ZaZiBoNa, the Southern African development community collaborative medicines registration initiative. Ther Innov Regul Sci. 2020;54(6):1319-1329. doi:1007/s43441-020-00154-y
  11. World Health Organization (WHO). South Africa’s Vaccine Regulator Reaches New WHO Level to Ensure Safety, Quality and Effectiveness. WHO; 2022. Available at: https://www.who.int/news/item/05-10-2022-south-africa-s-vaccine-regulator-reaches-new-who-level-to-ensure-safety-quality-effectiveness#:~:text=The%20designation%20Maturity%20Level%203,performance%20and%20with%20continuous%20improvement. Accessed January 30, 2024.
  12. Daniel E. Harmonising Medicines' Regulation in West Africa. The Guardian; 2019. Available at: https://guardian.ng/features/harmonising-medicines-regulation-in-west-africa/. Accessed January 30, 2024.
  13. Owusu-Asante M, Darko DM, Walker S, Salek S. Assessment of the effectiveness and efficiency of the West Africa Medicines Regulatory Harmonization initiative by the member countries. Front Pharmacol. 2022;13:1069345. doi:3389/fphar.2022.1069345
  14. Economic Community of West African States (ECOWAS). Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products. West African Health Organization (WAHO); 2019. Available at: https://www.wahooas.org/web-ooas/sites/default/files/publications/1993/wa-mrh-regional-joint-medicines-assessment-procedure.pdf. Accessed January 30, 2024.
  15. Barton I, Avanceña AL, Gounden N, Anupindi R. Unintended consequences and hidden obstacles in medicine access in sub-Saharan Africa. Front Public Health. 2019;7:342. doi:3389/fpubh.2019.00342
  16. Adler RH. Trustworthiness in qualitative research. J Hum Lact. 2022;38(4):598-602. doi:1177/08903344221116620
  17. Gunawan J. Ensuring trustworthiness in qualitative research. Belitung Nurs J. 2015;1(1):10-11.
  18. Ul Haq Kakar Z, Rasheed R, Rashid A, Akhter S. Criteria for assessing and ensuring the trustworthiness in qualitative research. Int J Bus Reflect. 2023;4(2):150-173. doi:56249/ijbr.03.01.44
  19. Howitt D, Cramer D. Introduction to Research Methods in Psychology. 2nd ed. New York: Pearson Education Ltd; 2008.
  20. Charmaz K. Constructing Grounded Theory: A Practical Guide Through Qualitative Analysis. Thousand Oaks: SAGE Publications; 2006.
  21. Spencer L, Ritchie J, O’Connor W, Morrell G, Ormston R. Analysis in practice. In: Ritchie J, Lewis J, eds. Qualitative Research Practice: A Guide for Social Science Students and Researchers. London: SAGE Publications; 2014.
  22. Sithole TD. An Evaluation of the Regulatory Review System in the Southern African Development Community Work Sharing Initiative (ZaZiBoNa): Enhancing the Review Process and Patients’ Access to Medicines [thesis]. Hatfield: University of Hertfordshire; 2022.
  23. Sithole T, Mahlangu G, Walker S, Salek S. Regulatory authority evaluation of the effectiveness and efficiency of the ZaZiBoNa collaborative medicines registration initiative: the way forward. Front Med (Lausanne). 2022;9:898743. doi:3389/fmed.2022.898743
  24. East African Community (EAC). East African Community Stakeholder’s Consultative Meeting on EAC Joint Regulatory Procedure and Sustainability Plan. EAC; 2022. Available at: https://www.eac.int/news-and-media/calendar-of-events/event/891-stakeholder%E2%80%99s-consultative-meeting-on-eac-joint-regulatory-procedure-and-sustainability-plan. Accessed January 30, 2024.
  25. Dansie LS, Odoch WD, Årdal C. Industrial perceptions of medicines regulatory harmonization in the East African Community. PLoS One. 2019;14(6):e0218617. doi:1371/journal.pone.0218617
  26. Australian Government Department of Health and Aged Care, Therapeutic Goods Administration. Australia-Canada-Singapore-Switzerland-United Kingdom (ACCESS) Consortium. Available at: https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium. Accessed January 30, 2024.
  27. Giaquinto AR, Grignolo A, Liberti L, et al. Improving access to quality medicines in East Africa: an independent perspective on the East African Community Medicines Regulatory Harmonization initiative. PLoS Med. 2020;17(8):e1003092. doi:1371/journal.pmed.1003092
  28. Sithole T, Salek S, Mahlangu G, Walker S. Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices. Expert Rev Clin Pharmacol. 2022;15(1):109-119. doi:1080/17512433.2022.1987883
  29. Sithole T, Mahlangu G, Salek S, Walker S. Evaluation of the regulatory review process in Zimbabwe: challenges and opportunities. Ther Innov Regul Sci. 2021;55(3):474-489. doi:1007/s43441-020-00242-z
  30. Bujar M, McAuslane N, Walker S, Salek S. The reliability and relevance of a quality of decision-making instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for use during the lifecycle of medicines. Front Pharmacol. 2019;10:17. doi:3389/fphar.2019.00017
  • Receive Date: 07 April 2023
  • Revise Date: 26 February 2024
  • Accept Date: 08 April 2024
  • First Publish Date: 09 April 2024