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