` The African Medicines Regulatory Harmonization Initiative: Progress to Date Progress to Date
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Abstract
The African Medicines Regulatory Harmonization Initiative (AMRH) has contributed to reduce marketing authorization timelines in East African Community and the Southern African Development Community member states. Challenges still exist in using the outcome of the regional joint dossier review processes for national decision making processes by the national medicines regulatory agencies.
Progress in domestication of the African Union Model Law on Medical Products Regulation by twelve countries provides basis for improving regulatory systems. This is coupled by the designation of eleven regional centers of regulatory excellence which will ensure sustainable training programmes and subsequent increase in Africa’s regulatory workforce.
The Biennial Scientific Conferences on Medical Products Regulation in Africa is a strategic platform for knowledge and ideas exchange among key stakeholders in the pharmaceutical sector. The ongoing alignment of the African Vaccines Regulators Forum, the Network of Medicines Control Laboratories in Sub-Saharan Africa, Pan African Harmonization Working Party on the regulation of medical devices and diagnostics, the planned establishment of a forum for blood and blood with AMRH serves as a solid foundation for establishment of the African Medicines Agency (AMA). AMA will be a key driver to remove technical barriers for trading among the region countries by contributing to the continental socio-economic development agenda.
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NDOMONDO-SIGONDA, Margareth et al.
` The African Medicines Regulatory Harmonization Initiative: Progress to Date.
Medical Research Archives, [S.l.], v. 6, n. 2, feb. 2018.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/1668>. Date accessed: 23 nov. 2024.
doi: https://doi.org/10.18103/mra.v6i2.1668.
Section
Review Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
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AMRH Newsletter, Q2: April-June 2017. Available at www.nepad.org/download/file/fid/3664%20. Accessed on 29 October 2017.
NEPAD, PATH. Increasing access to high quality, safe health technologies across Africa: AU Model Law on Medical Products Regulation. www.nepad.org/download/file/fid/3409%20. Accessed 7th May 2017.
NEPAD. AU Model Law on Medical Products Regulation. http://www.nepad.org/resource/african-union-au-model-law-medical-products-regulation. Accessed 7th May 2017.
Global Medicines Regulatory Harmonization Trust Fund, 2017 Annual Progress Report, World Bank Group.
World Health Organization (WHO) – Health and Human Rights. Accessed on 21 June 2017 on URL: http://www.who.int/mediacentre/factsheets/fs323/en/
Holt Tania, Lahrichi, Mehdi and Santos da Silva Jorge (2015) Africa: A Continent of Opportunity for Pharma and Patients. Last Accessed on 21 June 2017 on URL: http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/africa-a-continent-of-opportunity-for-pharma-and-patients
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NEPAD. AU Model Law on Medical Products Regulation. http://www.nepad.org/resource/african-union-au-model-law-medical-products-regulation. Accessed on 28 October 2017.
NEPAD. The African Medicines Quality Forum to improve quality control of medicines. Available on http://www.nepad.org/content/african-medicines-quality-forum-improve-quality-control-medicines. Accessed on 28 October 2017.
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Third Biennial Scientific Conference on Medical Products Regulation in Africa. Available at http://www.nepad.org/content/3rd-biennial-scientific-conference-medical-products-regulation-africa. Accessed on 28 October 2017.
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans
AMRH Newsletter. July – September 2017. Available at http://www.nepad.org/sites/default/files/documents/files/Newsletter_AMRH_Q3_2017.pdf. Accessed on 29 October 2017.
Report of Meeting of African Union and New Partnership for African Development’s Regional Centers of Regulatory Excellence (RCOREs) in Pharmacovigilance, May 14–15 2015, Accra, Ghana. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
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African Medicines Agency: Setting Milestones Towards its Establishment. Accessed on 18 June 2017 on URL: http://apps.who.int/medicinedocs/documents/s22304en/s22304en.pdf
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NEPAD Agency Head of Health Programmes Speech. 1st AMA Stakeholders Consultation Meeting, 22 February, 2017; Johannesburg, Pretoria. Available at http://www.nepad.org/content/african-medicines-agency. Accessed on 29 October 2017.
African Medicines Agency-Meeting Victoria Falls 29th August 2017-Documents. 2017. Available at https://au.int/en/documents/20170829/african-medicines-agency-meeting-victoria-falls-29th-august-2017-documents. Accessed on 29 October 2017.
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EAC. Integration Pillars. Available at https://www.eac.int/integration-pillars/common-market. Assessed on 29 October 2017.
Scofield, Ian (2017) African Regulatory Harmonization Project Cuts Drug Approval Times and Saves Scarce Resources. Accessed on 20 June 2017 on URL: https://pink.pharmamedtechbi.com/PS119932/African-Regulatory-Harmonization-Project-Cuts-Drug-Approval-Times-And-Saves-Scarce-Resources
NEPAD & WHO. AMRH Initiative: Summary, Status and Future Plans. November 2009. Available at http://apps.who.int/medicinedocs/documents/s20130en/s20130en.pdf. Accessed on 29 October 2017.
Tonya Villafana, World Bank. Medicines Regulation, Regulatory Harmonization, Global Initiatives. Presentation at China-Havard meeting, 13 September 2012. Available at http://www.worldbank.org/en/topic/health/brief/pharmaceutical-policy. Accessed 29 October 2017.
AMRH Newsletter. January-June 2016. Available at www.nepad.org/download/file/fid/3664%20. Accessed on 29 October 2017.
The African Medicines Regulatory Harmonization: Accomplishments, Challenges and Path Forward. Presentation made at the 17th International Conference for Drug Regulatory Authorities (ICDRA), Cape Town, South Africa. 27 November – 02 December 2016. Available at http://www.icdra.co.za/images/Presentions_Sunday/Sun_27_Nov_09h00_Ndomondo_Sigonda.pdf. Accessed 20 October 2017.
WHO support for medicines regulatory harmonization in Africa: focus on East African Community, WHO Drug Information Vol. 28 No. 1, 2014. http://www.who.int/medicines/publications/druginformation/DI_28-1_Africa.pdf; Accessed 28 October 2017.
Kamwanja L, Saka J, Awotedu A, Fute I, Chamdimba C, Ndomondo-Sigonda M. Situation Analysis Study on Medicines Registration Harmonization in Africa: Final Report for East African Community (EAC). 2010.
Kamwanja L, Saka J, Awotedu A, Fute I, Chamdimba C, Ndomondo-Sigonda M. SADC Situation Analysis Report. http://www.nepad.org/resource/situation-analysis-study-medicines-registration-harmonisation-africa-final-report-southern. 2010. Accessed 12 December 2016.
Kamwanja, L, Saka, J, Awotedu, A, Fute, I & Ndomondo-Sigonda, M. Situation Analysis Study on Medicines Registration Harmonization in Africa: Final Report for the Economic Community of West African States (ECOWAS). http://www.nepad.org/content/situation-analysis-study-medicines-registration-harmonisation-africa-%E2%80%93-final-report-economic. 2011. Accessed 12 December 2016.
East African Community Medicines Registration Harmonization Project, 2010. (Unpublished)
Malaria for Malaria Venture. Launch of the East African Community (EAC) Medicines Registration Harmonization (MRH) Project. Available at MV Website https://www.mmv.org/newsroom/events/launch-east-african-community-eac-medicines-registration-harmonization-mrh-project. Accessed 29 October 2017.
EAC. Presentation on Progress of EAC Medicines Registration Harmonization (MRH) Project. Jane Mashingia & Hiiti Sillo, 13 November 2012. San Diego, USA. Available at http://www.ich.org/fileadmin/Public_Web_Site/Meetings/C-GCG_Reports/2012/Nov_2012_EAC.pdf. Accessed on 29 October 2017.
C_Kumire. Regulatory Harmonization Initiatives. Presentation at the SAPPRA conference, 9_July 2015. Available at: http://sapraa.org.za/presentations/Jul2015/SADC%20SARPAM%20Regulatory%20Harmonisation%20Initiative%20-%20Celestine%20Kumire.pdf (accessed 28 October 2017). 20_January 2017).
NEPAD. Launching of the West Africa Medicines Registration Harmonization Project, 2015. Available at http://www.nepad.org/content/launching-west-africa-medicines-registration-harmonization-project. Accessed 29 October 2017.
Ian Schofield (2017) African Regulatory Harmonization Project Cuts Drug Approval Times and Saves Scarce Resources. Accessed 19 Mar 2017 on URL: https://pink.pharmamedtechbi.com/PS119932/African-Regulatory-Harmonization-Project-Cuts-Drug-Approval-Times-And-Saves-Scarce-Resources
Janssen Pharmaceutica Inc Pilot Study printed by Johnson & Johnson, accessible at: https://pink.pharmamedtechbi.com/PS119980/JanssenPilotSpeedsUpAfricanApprovalsAsHarmonizationProjectExpands
Medicines Control Authority of Zimbabwe website; Accessed on 24 October 2017 on URL: http://www.mcaz.co.zw/index.php/latest-news/16-zazibona-collaborative-medicines-registration-process
The International Journal for Professionals in regulatory affairs. Regulatory Rapporteur – Vol 14, No 11, November 2017
AMRH Newsletter, Q2: April-June 2017. Available at www.nepad.org/download/file/fid/3664%20. Accessed on 29 October 2017.
NEPAD, PATH. Increasing access to high quality, safe health technologies across Africa: AU Model Law on Medical Products Regulation. www.nepad.org/download/file/fid/3409%20. Accessed 7th May 2017.
NEPAD. AU Model Law on Medical Products Regulation. http://www.nepad.org/resource/african-union-au-model-law-medical-products-regulation. Accessed 7th May 2017.
Global Medicines Regulatory Harmonization Trust Fund, 2017 Annual Progress Report, World Bank Group.
World Health Organization (WHO) – Health and Human Rights. Accessed on 21 June 2017 on URL: http://www.who.int/mediacentre/factsheets/fs323/en/
Holt Tania, Lahrichi, Mehdi and Santos da Silva Jorge (2015) Africa: A Continent of Opportunity for Pharma and Patients. Last Accessed on 21 June 2017 on URL: http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/africa-a-continent-of-opportunity-for-pharma-and-patients
Carlos Lopez (2014) Manufacturing Pharmaceuticals: An Untapped Opportunity. Accessed on 21 June 2017, available on URL: http://www.uneca.org/es-blog/manufacturing-pharmaceuticals-untapped-opportunity
Situation Analysis on Counterfeit Medicines in Central Africa (2016) Report.
NEPAD, PATH. Increasing access to high quality, safe health technologies across Africa: AU Model Law on Medical Products Regulation. Available on www.nepad.org/download/file/fid/3409%20. Accessed 28 October 2017.
NEPAD. AU Model Law on Medical Products Regulation. http://www.nepad.org/resource/african-union-au-model-law-medical-products-regulation. Accessed on 28 October 2017.
NEPAD. The African Medicines Quality Forum to improve quality control of medicines. Available on http://www.nepad.org/content/african-medicines-quality-forum-improve-quality-control-medicines. Accessed on 28 October 2017.
USP. Fostering South-South Collaboration. Available on https://www.usp.org/global-health/fostering-south-south-collaboration. Accessed on 28 October 2017.
Report of Meeting of African Union and New Partnership for African Development’s Regional Centers of Regulatory Excellence (RCOREs) in Pharmacovigilance, May 14–15 2015, Accra, Ghana. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
Third Biennial Scientific Conference on Medical Products Regulation in Africa. Available at http://www.nepad.org/content/3rd-biennial-scientific-conference-medical-products-regulation-africa. Accessed on 28 October 2017.
African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans
AMRH Newsletter. July – September 2017. Available at http://www.nepad.org/sites/default/files/documents/files/Newsletter_AMRH_Q3_2017.pdf. Accessed on 29 October 2017.
Report of Meeting of African Union and New Partnership for African Development’s Regional Centers of Regulatory Excellence (RCOREs) in Pharmacovigilance, May 14–15 2015, Accra, Ghana. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
WHO. The African Vaccine Regulatory Forum (AVAREF): A platform for collaboration in a public health emergency. WHO Drug Information Vol. 29, No. 2, 20. Available at http://www.who.int/medicines/publications/druginformation/WHO_DI_29-2_RegulatoryCollaboration.pdf. Accessed on 29 October 2017.
Portia Nkambule. Presentation on Regional experience on the vaccines regulation harmonisation process: African Vaccines Regulatory Forum (AVAREF). Available at http://www.rr-africa.oie.int/docspdf/en/2017/VMP/NKAMBULE.pdf. Accessed on 29 October 2017.
African Medicines Agency: Setting Milestones Towards its Establishment. Accessed on 18 June 2017 on URL: http://apps.who.int/medicinedocs/documents/s22304en/s22304en.pdf
African Union Executive Council Decision EX.CL/872(XXVI). Twenty-Sixth Ordinary Session, 23 – 27 January 2015, Addis Ababa, Ethiopia. Available at: http://www.iri.edu.ar/publicaciones_iri/anuario/anuario_2015/Africa/29-UA-CE.pdf. Accessed 28 October 2017.
First Meeting of Specialised Technical Committee on Health, Population and Drug Control, Addis Ababa, Ethiopia, 13-17 April, 2015. Briefing Note on African Medicines Agency. AUC Publication. Available at http://apps.who.int/medicinedocs/documents/s22305en/s22305en.pdf. Accessed on 20 October 2017.
NEPAD Agency Head of Health Programmes Speech. 1st AMA Stakeholders Consultation Meeting, 22 February, 2017; Johannesburg, Pretoria. Available at http://www.nepad.org/content/african-medicines-agency. Accessed on 29 October 2017.
African Medicines Agency-Meeting Victoria Falls 29th August 2017-Documents. 2017. Available at https://au.int/en/documents/20170829/african-medicines-agency-meeting-victoria-falls-29th-august-2017-documents. Accessed on 29 October 2017.
McKinsey&Company (2015) Africa – A continent of opportunity for pharma and patients. Accessed on 19 May 2017, available on URL: http://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/africa-a-continent-of-opportunity-for-pharma-and-patients. Accessed on 29 October 2017.
United Nations Development Programme (2016) How Local Production of Pharmaceuticals Can Be Promoted in Africa – The Case of the United Republic of Tanzania. Accessed on 21 May 2017, available on URL: http://adphealth.org/upload/resource/Tanzania_Local_Production.pdf
EAC. Integration Pillars. Available at https://www.eac.int/integration-pillars/common-market. Assessed on 29 October 2017.