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: 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

1. Tenofovir (Viread), first novel antiviral agent in six years, approved by FDA. Treatment Action Group website. 2001 [cited 2019 March 25]. Available from: http://www.treatmentactiongroup.org/tagline/2001/november/tenofovir-viread-first-novel-antiviral-agent-six-years-approved-fda.

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.

4. Wise J. Access to AIDS medicines stumbles on trade rules. Bull WHO 2006;84(5):337–424.

5. Ahonkhai V, Martins SF, Portet A, Lumpkin M, Hartman D. Speeding access to vaccines and medicines in low- and middle-income countries: A case for change and a framework for optimized product market authorization. PLoS ONE. 2016;11(11):e0166515. doi: 10.1371/journal.pone.0166515 27851831

6. Narsai K, Williams A, Mantel-Teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries—perceptions and experiences of pharmaceutical companies in South Africa. South Med Rev. 2012;5(1):31–7. 23093897

7. Kamwanja L, Saka J, Awotedu A, Fute I, Chamdimba C, Ndomondo-Sigonda M. Situational Analysis Study on Medicines Registration Harmonisation in Africa: Final Report for the East African Community. NEPAD, 2010.

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.

10. Holt T, Lahrichi M, Santos da Silva J. Africa: A Continent of Opportunities for Pharma and Patients. McKinsey & Company, 2015.

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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