Coming together to improve access to medicines: The genesis of the East African Community’s Medicines Regulatory Harmonization initiative
Autoři:
Hiiti Sillo aff001; Aggrey Ambali aff002; Samvel Azatyan aff001; Chimwemwe Chamdimba aff002; Eliangiringa Kaale aff003; Joseph Kabatende aff004; Murray Lumpkin aff005; Jane H. Mashingia aff006; David Mukanga aff005; Bonaventure Nyabenda aff007; Gordon Sematiko aff008; Margareth Sigonda aff002; Burhani Simai aff009; Fred Siyoi aff010; Stanley Sonoiya aff006; Mike Ward aff001; Vincent Ahonkhai aff011
Působiště autorů:
World Health Organization, Geneva, Switzerland
aff001; African Union Development Agency–New Partnership for Africa’s Development, Midrand, South Africa
aff002; School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
aff003; Rwanda Food and Drugs Authority, Kigali, Rwanda
aff004; Bill & Melinda Gates Foundation, Seattle, Washington, United States of America
aff005; East African Community Secretariat, Arusha, Tanzania
aff006; Directorate of Pharmacy, Medicines, and Laboratories, Bujumbura, Burundi
aff007; National Drug Authority, Kampala, Uganda
aff008; Zanzibar Food and Drug Agency, Zanzibar City, Zanzibar
aff009; Pharmacy & Poisons Board, Nairobi, Kenya
aff010; Gwynedd Consultancy, LLC, Philadelphia, Pennsylvania, United States of America
aff011
Vyšlo v časopise:
Coming together to improve access to medicines: The genesis of the East African Community’s Medicines Regulatory Harmonization initiative. PLoS Med 17(8): e1003133. doi:10.1371/journal.pmed.1003133
Kategorie:
Collection Review
doi:
https://doi.org/10.1371/journal.pmed.1003133
Souhrn
Hiiti Sillo and colleagues reveal how the East African Community’s Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.
Klíčová slova:
Africa – Consortia – Drug regulation – Global health – Kenya – Rwanda – Tanzania – Uganda
Zdroje
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2. Rationale for tenofovir as the first choice in the first-line treatment of HIV. Medicins sans Frontieres Access Campaign website. 2012 [cited 2019 March 25]. Available from: https://msfaccess.org/rationale-tenofovir-first-choice-first-line-treatment-hiv.
3. Gilead’s tenofovir access program for developing countries. Doctors Without Borders website. 2006 [cited 2019 March 25]. Available from: https://www.doctorswithoutborders.org/what-we-do/news-stories/research/gileads-tenofovir-access-program-developing-countries.
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8. Pharmaceutical Manufacturing Plan for Africa. Addis Ababa: African Union, 2012.
9. Making The Case: How Regulatory Harmonisation Can Save Lives In Africa. Washington, DC: PATH, 2018.
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11. 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).
12. WHO support for medicines regulatory harmonization in Africa: Focus on East African Community. WHO Drug Inform. 2014;28(1):11–5.
13. Sillo H. Comparison of medicines legislation in the East African Community. WHO Drug Inform. 2016;30(4):567–76.
14. East African Community website. 2019 [cited 2019 April 19]. Available from: https://www.eac.int/.
15. Mashingia J, Patel A. Pharmaceutical policy in the East African Community: Burundi, Kenya, Uganda, Rwanda, Tanzania. In: Babar Z, editor. Pharmaceutical Policy in Countries with Developing Healthcare Systems. New York City: Springer; 2017. p. 13–24.
16. Moran M, Guzman J, McDonald A, Wu L, Omune B. Registering New Drugs: The African Context. Sydney: George Institute, 2010.
17. Assessment of Medicines Regulatory Systems in sub-Saharan African Countries. Geneva: World Health Organization, 2010.
18. 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. https://doi.org/10.1371/journal.pmed.1003134
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