The African Medicines Regulatory Harmonization Initiative: Progress to Date

Ndomondo-Sigonda, Margareth; Miot, Jacqui; Naidoo, Shan; Ambali, Aggrey; Dodoo, Alexander; Mkandawire, Hlazo

doi:10.18103/mra.v6i2.1668

Cited by 37 publications

(60 citation statements)

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“…In recognition of the need to ensure that all African citizens have access to safe, quality and efficacious essential medicines, the African Union approved the African Medicines Regulatory Harmonization (AMRH) Initiative as a key pillar of the Pharmaceutical Manufacturing Plan for Africa (PMPA) [22]. The AMRH Initiative which covers more than 85% of Sub-Saharan Africa serves as a foundation for establishment of the African Medicines Agency.…”

Section: Plos Onementioning

confidence: 99%

National medicines regulatory authorities financial sustainability in the East African Community

et al. 2020

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Introduction Adequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainland and Zanzibar) and Uganda. Methodology An exploratory, mixed method design using both qualitative and quantitative data, was employed. Data from six NMRAs was collected through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs and monitoring and evaluation experts of the respective agencies. NMRA's financing was assessed using six indicators namely, funding policy, financial autonomy, the total annual budget, actual funding per annum, funds received from various sources, and the NMRA expenditure. Results The average total annual budget for all the EAC countries during the study period 2011-2015 ranged from USD 824,328.67 to USD 10,724,536.50. The low budget in Zanzibar may be attributed to population and pharmaceutical market size. Uganda's attainment of 98.75% (USD 10,656,704) revenue from industry fees is a result of deliberate government policy change from 100% reliance on donor funding over a period of 10 years (1995-2015). On average, the proportion of revenue against budget per annum is 54.8% (USD 458,970.11),

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Section: Plos Onementioning

confidence: 99%

National medicines regulatory authorities financial sustainability in the East African Community

et al. 2020

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“…A reliance mechanism (where an agency relies on others in making a regulatory decision) exists in Kenya, Tanzania-Mainland, Tanzania-Zanzibar and Uganda while it was not the case for Burundi and Rwanda. Results on number of products applications received per annum (Table 4, under indicator 8) indicated the highest ve years average of 800 new applications were received by the TMDA, followed by NDA (458), Burundi (70) and ZFDA (16). The PPB and RFDA indicated to have received 1030 and 833 applications respectively in 2016.…”

Section: Resultsmentioning

confidence: 99%

Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

Ndomondo-Sigonda

Miot

Naidoo

et al. 2020

Preprint

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Background: Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods: An exploratory mixed-method design using both qualitative and quantitative data was employed. Data was collected from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat through a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 whereas 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer. A set of 14 indicators grouped into 6 categories were used to measure NMRAs performance. Results: Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification.Conclusions: The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

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“…Finally, the EAC MRH initiative's work will help determine whether the African Medicines Agency becomes a reality as well as the shape this new regulatory authority will take [24,25]. With Africa's steadily increasing population, developing efficient and competent regulatory mechanisms is becoming more important than ever, and the African Medicines Agency may have an important role in this work.…”

Section: Next Steps For the Eac Mrh Initiativementioning

confidence: 99%

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Giaquinto¹,

Grignolo

Liberti

et al. 2020

PLoS Med

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• The goal of improving access to quality medicines in East Africa has been addressed by the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative, which is working to simplify the process of registering medicines and increase the speed at which registration applications are reviewed while ensuring that only highquality medicines are approved. • This article was written by a group of authors with varied expertise in global regulatory affairs but no involvement to date in the EAC MRH initiative. The authors were asked to provide an independent perspective on the initiative's work since its launch in 2012, as well as its plans for the future.

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The African Medicines Regulatory Harmonization Initiative: Progress to Date

Cited by 37 publications

References 1 publication

National medicines regulatory authorities financial sustainability in the East African Community

National medicines regulatory authorities financial sustainability in the East African Community

Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

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