Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

References

• African Union. African Medicine Agency (AMA) Treaty | African Union. 2020. https://au.int/en/pressreleases/20200205/african-medicine-agency-ama-treaty. Accessed 3 Mar 2020.
   Google Scholar
• African Union. African Union Member States. 2013. http://www.au.int/en/member_states/countryprofiles. Accessed 19 July 2020.
   Google Scholar
• World Health Organization. WHO | The African Regional Health Report: The health of the people. 2020. https://www.who.int/bulletin/africanhealth/en/. Accessed 25 Aug 2020.
   Google Scholar
• NEPAD. Justification for the African Union Model Law on medical products regulation and harmonisation.
   Google Scholar
• Dansie LS, Odoch WD, Årdal C. Industrial perceptions of medicines regulatory harmonization in the East African Community. PLoS ONE. 2019;14(6):e0218617. https://doi.org/10.1371/journal.pone.0218617.
   PubMed Web of Science ®Google Scholar
• Ozawa S, Evans DR, Bessias S, Haynie DG, Yemeke TT, Laing SK, et al. Prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries: a systematic review and meta-analysis. JAMA Netw Open. 2018;1(4):e181662.
   PubMed Web of Science ®Google Scholar
• NPCA Agency. First scientific conference on Medicines Regulation in Africa. In Johannesburg; 2013.
   Google Scholar
• World Health Organization. African Medicines Regulatory Harmonization Initiative (AMRHI): a WHO Concept Paper. WHO Drug Inf. 2008;22(3):182–90. http://search.ebscohost.com/login.aspx?direct=true&db=hch&AN=35618550&site=ehost-live.
   Google Scholar
• Calder A. Assessment of potential barriers to medicines regulatory harmonization in the Southern African Development Community (SADC) Region. 2016;1–97.
   Google Scholar
• Glover B, Akinbo O, Savadogo M, Timpo S, Lemgo G, Sinebo W, et al. Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD’s experience in establishing regulatory systems for medicines and GM crops in Africa. BMC Proc. 2018;12(Suppl 8):11.
   PubMedGoogle Scholar
• African Union. African Medicines Agency Business Plan.
   Google Scholar
• World Health Organization. Towards a global competency framework for regulators of medical products. Geneva: World Health Organization; 2019.
   Google Scholar
• AUC-UNIDO. Pharmaceutical manufacturing plan for Africa: business plan. Vol. 1. Austria; 2012. 1–119 p. https://www.nepad.org/publication/pharmaceutical-manufacturing-plan-africa.
   Google Scholar
• UNDP. Issue brief. African Union Model Law for Medical Products Regulation: increasing access to and delivery of new health technologies for patients in need. p. 1–12. http://adphealth.org/upload/resource/AUModelLaw.pdf.
   Google Scholar
• NEPAD Agency; PATH. Increasing access to high-quality, Safe Health Technologies across Africa: African Union Model Law on Medical Products Regulation. 2016. https://path.azureedge.net/media/documents/APP_au_model_law_br.pdf.
   Google Scholar
• NEPAD-WHO. African Medicines Registration Harmonisation (AMRH) Initiative: summary, status and future plans. 2009.
   Google Scholar
• 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):31–37.
   PubMedGoogle Scholar
• Ndomondo-Sigonda M, Ambali A. The African Medicines Regulatory Harmonization Initiative: rationale and benefits. Clin Pharmacol Ther. 2011;89(2):176.
   PubMed Web of Science ®Google Scholar
• 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). https://journals.ke-i.org/mra/article/view/1668. Accessed 15 Feb 2018.
   Google Scholar
• Ndomondo-Sigonda M, Miot J, Naidoo S, Dodoo A, Kaale E. Medicines Regulation in Africa: current state and opportunities. Pharm Med. 2017;31(6):383–397.
   PubMed Web of Science ®Google Scholar
• Mwangi JM. Towards African medicines regulatory harmonization: the case of the East African Community. Pharm Policy Law. 2016;18(1–4):91–98
   Google Scholar
• Dellepiane N, Pagliusi S. Challenges for the registration of vaccines in emerging countries: differences in dossier requirements, application and evaluation processes. Vaccine. 2018;36(24):3389–3396.
   PubMed Web of Science ®Google Scholar
• Roth L, Bempong D, Babigumira JB, Banoo S, Cooke E, Jeffreys D, et al. Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems. Glob Health. 2018;14(1):102. https://doi.org/10.1186/s12992-018-0421-2.
   PubMedGoogle Scholar
• African Union. African Union Ministers of Health adopt treaty for the establishment of the African Medicines Agency. 2018. https://au.int/sites/default/files/pressreleases/34320-pr-press_statement_ama_treaty1.pdf.
   Google Scholar
• Luthuli N, Robles W. Africa medicines regulatory harmonization initiatives. Carlsbad: WCG; 2017.
   Google Scholar
• Kamwanja LA., Sake J, Awotedu A, Fute I, Ndomondo-Sigonda M. Situation analysis study on medicines registration harmonisation in Africa, final report for the Economic Community of West African States. 2011;(June). https://www.nepad.org/publication/situation-analysis-study-medicinesregistration-harmonisation-africa-final-report-2.
   Google Scholar
• African Union. Treaty for the establishment of the African Medicines Agency. Addis Ababa, Ethiopia: African Union (AU); 2019. https://au.int/sites/default/files/treaties/36892-treaty-0069_-_ama_treaty_e.pdf.
   Google Scholar
• IFPMA. IFPMA welcomes set-up of New African Medicines Agency. 2018 May 25;1. https://www.ifpma.org/wp-content/uploads/2018/05/IFPMA_PR_AMA_FINAL_25.05.2018.pdf.
   Google Scholar
• Lahlou O. Accelerating patient access to medicines in the Economic Community of West African States, the Southern African Development Community and the organization for the coordination of the fight against endemic diseases. Pharm Policy Law. 2016;18(1–4):99–108.
   Google Scholar
• AUC-WHO. First meeting of African Ministers of Health jointly convened by the AUC and WHO. Luanda; 2014.
   Google Scholar
• African Union & WHO. African Medicines Agency: setting milestones towards its establishment. Vol. 1. 2014. p. 1–8.
   Google Scholar
• World Health Organization. WHO | WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems. https://www.who.int/medicines/regulation/benchmarking_tool/en/. Accessed 25 Aug 2020.
   Google Scholar
• WHO | List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3)1 and maturity level 4 (ML4)2 (as benchmarked against WHO Global Benchmarking Tool (GBT)3. WHO. 2020. http://www.who.int/medicines/areas/regulation/nras_ml3_ml4/en/. Accessed 14 Oct 2020.
   Google Scholar
• African Union Commission. Implementing the African Union Model Law at the Regional and National Level. 2016. https://www.nepad.org/file-download/download/public/15452.
   Google Scholar
• Vawda Y, Gray A. Transparency in Medicines Regulatory Affairs—reclaiming missed opportunities. South African J Bioeth Law. 2017;10:69. https://www.researchgate.net/publication/326386521_Transparency_in_Medicines_Regulatory_Affairs_-_Reclaiming_Missed_Opportunities/link/5b525ba60f7e9b240ff27902/download.
   Google Scholar
• 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. https://doi.org/10.1007/s43441-020-00154-y.
   PubMed Web of Science ®Google Scholar
• Barton I, Avanceña ALV, Gounden N, Anupindi R. Unintended consequences and hidden obstacles in medicine access in Sub-Saharan Africa. Front Public Health. 2019;7:342.
   PubMed Web of Science ®Google Scholar
• Mukanga D. African Medicines Agency Treaty Endorsed by African Union. 2019. https://globalforum.diaglobal.org/issue/april-2019/african-medicines-agency-treaty-endorsed-by-african-union/. Accessed 3 Mar 2020.
   Google Scholar
• Schlesinger D. African Heads of State Endorse Continental Medicine Regulator—Health Policy Watch. 2019. https://www.healthpolicy-watch.org/african-heads-of-state-endorse-continental-medicine-regulator/. Accessed 3 Mar 2020.
   Google Scholar
• African Union. The Republic of Rwanda Signs the Treaty for the Establishment of the African Medicine Agency (AMA). 2019 Jun 12. https://au.int/en/pressreleases/20190612/republic-rwanda-signs-treaty-establishment-african-medicine-agency-ama.
   Google Scholar
• Jerving S. African Union needs more country support to launch the African Medicines Agency | Devex. 2020. https://www.devex.com/news/african-union-needs-more-country-support-to-launch-the-african-medicines-agency-97624. Accessed 26 Aug 2020.
   Google Scholar
• AUDA-NEPAD. African Medicines Regulatory Harmonisation Programme 2nd Quarter 2020 Newsletter Edition. [Internet]. Midrand, South Africa: AUDA-NEPAD; 2020. p. 1. https://www.nepad.org/file-download/download/public/127740.
   Google Scholar
• African Union. African Medicines Agency: Briefing Notes. First Meeting of the Specialized Technical Committee on Health, Population and Drug Control (STC-HPDC-1), Addis Ababa, Ethiopia, 13–17 April 2015. Addis Ababa, Ethiopia; 2015. http://apps.who.int/medicinedocs/documents/s22305en/s22305en.pdf.
   Google Scholar
• Zarocostas J. Health ministers adopt African Medicines Agency treaty. Lancet. 2018;391(10137):2310.
   PubMed Web of Science ®Google Scholar
• NEPAD, PATH. Understanding the role of Regional Centres of Regulatory Excellence in strengthening medicines regulation in Africa. 2014.
   Google Scholar
• USFDA. International Regulatory Harmonization | FDA. https://www.fda.gov/drugs/cder-international-program/international-regulatory-harmonization. Accessed 21 July 2020.
   Google Scholar
• African Union. Regional Economic Communities (RECs) | African Union. https://au.int/en/organs/recs. Accessed 21 July 2020.
   Google Scholar
• Zerhouni E, Hamburg M. The need for global regulatory harmonization: a public health imperative. Sci Transl Med. 2016;8(338):338ed6 LP-338ed6. http://stm.sciencemag.org/content/8/338/338ed6.abstract.
   Google Scholar
• Preston C, Valdez ML, Bond K. Strengthening medical product regulation in low- and middle-income countries. PLoS Med. 2012;9(10):e1001327. https://doi.org/10.1371/journal.pmed.1001327.
   PubMed Web of Science ®Google Scholar