A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

English version

Autoři: Margareth Ndomondo-Sigonda ^aff001; Gugu Mahlangu ^aff002; Margaret Agama-Anyetei ^aff003; Emer Cooke ^aff004
Působiště autorů: African Union Development Agency–New Partnership for Africa’s Development, Midrand, South Africa ^aff001; Medicines Control Authority, Harare, Zimbabwe ^aff002; African Union Commission, Addis Ababa, Ethiopia ^aff003; World Health Organization, Geneva, Switzerland ^aff004
Vyšlo v časopise: A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative. PLoS Med 17(8): e32767. doi:10.1371/journal.pmed.1003099
Kategorie: Collection Review
doi: https://doi.org/10.1371/journal.pmed.1003099

Zdroje

1. Nickerson JW, Attaran A, Westerberg BD, Curtis S, Overton S, Mayer P. Fatal bacterial meningitis possibly associated with substandard ceftriaxone—Uganda, 2013. MMWR Morb Mortal Wkly Rep. 2016;64(50–51):1375–7. doi: 10.15585/mmwr.mm6450a2 26720749

2. Hajjou M, Krech L, Lane-Barlow C, Roth L, Pribluda VS, Phanouvong S, et al. Monitoring the quality of medicines: results from Africa, Asia, and South America. Am J Trop Med Hyg. 2015;92(6 Suppl):68–74. doi: 10.4269/ajtmh.14-0535 25897073

3. Bassat Q, Tanner M, Guerin PJ, Stricker K, Hamed K. Combating poor-quality anti-malarial medicines: a call to action. Malar J. 2016;15:302. doi: 10.1186/s12936-016-1357-8 27251199

4. Nayyar GM, Breman JG, Newton PN, Herrington J. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis. 2012;12(6):488–96. doi: 10.1016/S1473-3099(12)70064-6 22632187

5. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa, WHO/EMP/QSM/2011.1. Geneva: World Health Organization, 2011.

6. Renschler JP, Walters KM, Newton PN, Laxminarayan R. Estimated under-five deaths associated with poor-quality antimalarials in sub-Saharan Africa. Am J Trop Med Hyg. 2015;92(6 Suppl):119–26. doi: 10.4269/ajtmh.14-0725 25897068

7. Ogisi M. Fake medicine common in many sub-Saharan African countries. Gallup website. 2011 [cited 2019 June 14]. Available from: https://news.gallup.com/poll/149942/fake-medicine-common-sub-saharan-african-countries.aspx.

8. Agyepong IA, Sewankambo N, Binagwaho A, Coll-Seck AM, Corrah T, Ezeh A, et al. The path to longer and healthier lives for all Africans by 2030: the Lancet Commission on the future of health in sub-Saharan Africa. Lancet. 2018;390(10114):2803–59. doi: 10.1016/S0140-6736(17)31509-X 28917958

9. Strengthening the Capacity for Regulation of Medical Products in the African Region: Report of the Secretariat, AFR/RC63/7. Geneva: World Health Organization, Regional Office for Africa, 2013.

10. Ndomondo-Sigonda M, Agama-Anyetei M, Mahlangu G, Mkandawire H. African Medicines Agency Establishment Treaty adopted by African Ministers of Health. DIA Global Forum website. 2018 [cited 2019 May 30]. Available from: https://globalforum.diaglobal.org/issue/july-2018/african-medicines-agency-establishment-treaty-adopted-by-african-ministers-of-health/.

11. Universal Declaration of Human Rights. United Nations website. 1948 [cited 2019 June 14]. Available from: https://www.un.org/en/universal-declaration-human-rights/.

12. Transforming our world: the 2030 Agenda for Sustainable Development. United Nations Sustainable Development Goals website. 2015 [cited 2019 June 14]. Available from: https://sustainabledevelopment.un.org/post2015/transformingourworld.

13. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, et al. Essential medicines for universal health coverage. Lancet. 2017;389(10067):403–76. doi: 10.1016/S0140-6736(16)31599-9 27832874

14. Ndomondo-Sigonda M, Miot J, Naidoo S, Ambal A, Dodoo A, Mkandawire H. The African Medicines Regulatory Harmonization initiative: Progress to date. Medical Res Arch. 2018;6(2).

15. Sillo H, Ambali A, Azatyan S, Chamdimba C, Kaale E, Kabatende J, 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: 10.1371/journal.pmed.1003133

16. Mashingia JH, Ahonkhai V, Aineplan N, Ambali A, Angole A, Arik M, et al. Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned. PLoS Med. 2020;17(8): e1003134. doi: 10.1371/journal.pmed.1003134

17. Arik M, Bamenyekanye E, Fimbo A, Kabatende J, Kijo AS, Simai B, et al. Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future. PLoS Med. 2020;17(8): e1003129. doi: 10.1371/journal.pmed.1003129

18. Giaquinto AR, Grignolo A, Liberti L, Lim JCW, Salmonson T, Sauer F, 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(7): e1003092. doi: 10.1371/journal.pmed.1003092

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