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The Roadmap for the Future of the EAC's MRH initiative, 2020-2022. CRO, contract research organization; EAC, East African Community; GMP, good manufacturing practice; ISO, International Organization for Standardization; IVD, in vitro diagnostic; JA, joint assessment; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; PV, pharmacovigilance; RTO, regional technical officer; WHO, World Health Organization. https://doi.org/10.1371/journal.pmed.1003129.g001

The Roadmap for the Future of the EAC's MRH initiative, 2020-2022. CRO, contract research organization; EAC, East African Community; GMP, good manufacturing practice; ISO, International Organization for Standardization; IVD, in vitro diagnostic; JA, joint assessment; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; PV, pharmacovigilance; RTO, regional technical officer; WHO, World Health Organization. https://doi.org/10.1371/journal.pmed.1003129.g001

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• The East African Community (EAC)’s Medicines Regulatory Harmonization (MRH) initiative was created to improve access to quality, safe medicines in the region by simplifying the regulatory process while maintaining a high level of rigor. Building on lessons learned since its launch in 2012, the EAC MRH initiative has created a Roadmap for the Futu...

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... address these problems, the Roadmap (Fig 1) calls for a cadre of regional technical officers (RTOs) who are focused on the day-to-day management of joint activities. In the pilot phase of the EAC MRH initiative, the EAC Secretariat hired one officer for each NMRA to conduct program activities. ...

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... This approach facilitates specialisation, ensures that all member states actively participate in the initiative and leverage the region's limited expertise [10,46]. The EAC MRH initiative is now implementing its "Roadmap for the Future, 2020-2022," which was approved in 2018 by the EAC's Council of Health Ministers [49]. The Roadmap calls for the appointment of regional technical officers (RTOs) who concentrate solely on the day-to-day management of joint regulatory activities as well as recommend programmatic changes to the EAC MRH initiative's Steering Committee [49]. ...
... The EAC MRH initiative is now implementing its "Roadmap for the Future, 2020-2022," which was approved in 2018 by the EAC's Council of Health Ministers [49]. The Roadmap calls for the appointment of regional technical officers (RTOs) who concentrate solely on the day-to-day management of joint regulatory activities as well as recommend programmatic changes to the EAC MRH initiative's Steering Committee [49]. Therefore, each NRA in the region now has an RTO that specialises in a different regulatory domain and serves as the contact point for joint activities. ...
... Therefore, each NRA in the region now has an RTO that specialises in a different regulatory domain and serves as the contact point for joint activities. Burundi's RTO supports the oversight of clinical trials; Kenya, pharmacovigilance; Rwanda, information management systems; South Sudan, policy, legal, and regulatory reforms; Tanzania, joint product assessments; Uganda, joint GMP inspections; and Zanzibar, quality management systems [49]. ...
Article
The medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs' regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development.
... In the long term, the establishment of a regional medicines authority was proposed as a strategy for moving forward. This is not unique to SADC and has also been proposed for other harmonisation initiatives (21,23,24). To do this, a binding memorandum of understanding should be developed mandating the establishment of the regional medicines authority. ...
Article
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Introduction The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African Development Community ZaZiBoNa, established in 2013. A recent study was carried out with the nine active member regulatory authorities of the ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having obtained the authorities’ views, the aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative including the challenges it faces as well as identifying opportunities for improvement from the applicants’ perspective. Methods Applicants who had submitted registration/marketing authorisation applications for assessment under the ZaZiBoNa initiative during 2017–2021 were recruited into the study. Data was collected in 2021 using the Process, Effectiveness and Efficiency rating questionnaire (PEER-IND) developed by the authors. The questionnaire was completed by a representative responsible for ZaZiBoNa submissions in each company. Results The pharmaceutical industry was of the view that the ZaZiBoNa initiative has achieved shorter timelines for approval of medicines, resulting in increased availability of quality-assured medicines for patients in the SADC region. Harmonisation of registration requirements and joint reviews have reduced the workload for both the pharmaceutical industry and the regulatory authorities. Some of the challenges identified were the lack of a centralised submission and tracking system, and the lack of information for applicants on the process for submission of ZaZiBoNa dossiers/applications in the individual countries, including contact details of the focal person. The establishment of a regional unit hosted in one of the member countries to centrally receive and track ZaZiBoNa dossiers/applications was identified as the best strategy for moving forward in the interim with the long-term goal being the establishment of a regional medicines authority. Conclusion There was consensus between the pharmaceutical industry and the regulatory authorities as to the way forward to improve the effectiveness and efficiency of the ZaZiBoNa initiative. Implementation of the recommendations identified in this study will lead to enhanced regulatory performance.
... Previous evaluations of regulatory work have been published. 8,[14][15][16][17] We provide an updated review with a focus on medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA). 18 COSECSA is the largest surgical training institution in sub-Saharan Africa, with a diverse international surgical membership who commonly use a wide range of medical devices. ...
Article
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Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; rs=0.90) and years of freedom from colonization (rs=0.60), and less positively correlated to GDP per capita (rs=0.40). Although most countries mandate medical device regulation in national legislation, few employ all the guidelines set forth by the World Health Organization. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.
... This includes a coordination fee to support regional assessment and inspection processes to complement donor funding. The long-term goal is to establish a semi-autonomous EAC Medicines Agency which will ensure that the program continues to grow and improve [44]. ...
... Regulatory activities will also be expanded to cover clinical trials oversight, safety and quality surveillance initiatives. Furthermore, the initiative has welcomed the South Sudan's new NMRA towards addressing the regulatory challenges as the youngest member of the EAC [44]. ...
Article
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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 to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess 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.
... • The individuals tasked with shaping the program's next phase describe their plans for the coming years in the third paper [17]. ...
... Today, the EAC MRH initiative is poised to transition from a donor-funded pilot project into a self-sustaining, permanent feature of the African regulatory landscape, as discussed in the third paper in the Collection [17], helping to provide the engine for developing the new AMA. We anticipate that the AMA will build on the initiative's accomplishments to advance regulatory harmonization across the African continent. ...
Article
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Substandard and/or falsified medical products may result in treatment failure and/or death. The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiative, serves as a lesson for scaling up the African Medicines Regulatory Harmonization Program across the continent. Currently, the East African Community’s Medicines Regulatory Harmonization initiative is poised to transition from a donor-funded pilot project into a self-sustaining, permanent feature of the African regulatory landscape. Government, partner, and public support is needed for strong systems to regulate medicines in the East African Community and elsewhere in the world. Copyright: © 2020 Ndomondo-Sigonda et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
... Under the guidance of a recently convened working group led by Kenya's NMRA, the initiative also drafted harmonized guidelines for pharmacovigilance, as well as a pharmacovigilance roadmap and business plan to guide activities in this area. In March 2019, the EAC Sectoral Council of Ministers approved the EAC Harmonized Compendium of Guidelines for Pharmacovigilance [11], and the initiative has also announced plans to expand into laboratory testing of medicines and postmarketing surveillance in the coming years, described in more detail in an accompanying paper in this collection, Optimizing the East African Community's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future [12]. ...
... Similar problems were noted for joint GMP inspections in the BCG evaluation in 2017. How the initiative addressed these and other problems is described in an accompanying paper in this collection [12]. ...
... Heads of agencies have now also committed to covering most meeting costs, with donor funding covering only the costs of flying to face-to-face meetings going forward. The EAC MRH Steering Committee has indicated its commitment to transitioning to an EAC Medicines Agency-and fee-based funding system, but this process has not yet begun; future plans to address funding and other challenges are described in an accompanying article in this collection [12]. ...
Article
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Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them. • In this article, we explore the progress the East African Community's Medicines Regulatory Harmonization (EAC MRH) initiative, launched in 2012, has made toward its goal of improving access to essential medicines. The initiative's initial focus was on registering generic medicines, with a plan to expand to other classes of medical products, as well as to other regulatory functions. • From 2012 to 2017, the timeline for national assessments of medicinal product applications decreased from roughly 24 months to 8-14 months, if products were assessed through the new joint assessment process (involving 2 or more national medicines regulatory authorities). • Since 2015, the initiative has conducted 10 joint product assessment sessions in which 83 medicinal product applications were considered, resulting in the recommendation of 36 products for registration by EAC Partner States. • Overall, the median timeline for a joint assessment, from submission of the application through final decision, has been a little over a year (372 days); 170 of these days represent time used by manufacturers to answer queries. However, the median timeline for a joint assessment in 2019 was only 240 days, indicating that the process has become more efficient. • Shifting from relying on donor support to becoming self-sustaining remains a challenge for the EAC MRH initiative.
... In the final article in this Special Collection in PLOS Medicine about the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative [1][2][3][4], we, a group of authors who have had no involvement in the EAC MRH's work to date, provide an independent perspective on the program's work thus far and its plans for the future. The initiative's goal is to improve access to essential medicines in East Africa by simplifying the process of registering medicines and increasing the speed at which registration applications are reviewed while ensuring that only high-quality medicines are approved. ...
... Dr Grignolo then invited us to contribute, as a team of coauthors with rich and varied experience in regulatory harmonization. We were provided with drafts of the other articles in the Special Collection [1][2][3][4], but otherwise, this perspective was written without input or influence from the other authors or from the EAC MRH initiative or its partners, including the Bill & Melinda Gates Foundation. Information about each author's background can be found in S1 Text. ...
... This includes a coordination fee to support regional assessment and inspection processes to complement donor funding. The long-term goal is to establish a semiautonomous EAC Medicines Agency which will ensure that the program continues to grow and improve [44]. ...
... Regulatory activities will also be expanded to cover clinical trials oversight, safety and quality surveillance initiatives. Furthermore, the initiative has welcomed the South Sudan's new NMRA towards addressing the regulatory challenges as the youngest member of the EAC [44]. ...
Preprint
Full-text available
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 to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11-2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess 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.
... This includes a coordination fee to support regional assessment and inspection processes to complement donor funding. The long-term goal is to establish a semi-autonomous EAC Medicines Agency which will ensure that the program continues to grow and improve [41]. ...
... Furthermore, the initiative has welcomed the South Sudan's new NMRA towards addressing the regulatory challenges in the youngest member of the EAC [41]. ...
Preprint
Full-text available
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.
... However, a study on Medicines Regulation in Africa has shown that most NMRAs in Africa have little capacity to perform all key regulatory functions [9]. In East African Community, SF medicines have been reported in all member states [10]. ...
... These findings were also reported by MTaPS which conducted a study in seven African countries and two Asian countries to evaluate the registration systems of medicines used in maternal, newborn and child healthcare [21]. One of the solutions to the lengthy registration process may be the strengthening of the existing harmonization of medicines regulation in the East African Countries [10,22] and the proposed African Medicines Agency (AMA) [9,23]. ...
Article
Full-text available
    Background Access to quality medicines is a global initiative to ensure universal health coverage. However, the limited capacity of National Medicines Regulatory Authorities (NMRAs) to prevent and detect the supply of poor-quality medicines led to the predominance of sub-standard and falsified (SF) medicines in the supply chains of many countries. Therefore, this study was designed to assess the capacity of a young NMRA to ensure the quality of medicines with Rwanda as a case study. Objective This study aimed to assess the capacity of the Rwanda FDA, a young NMRA, to identify gaps and existing opportunities for improving regulatory capacity and ensuring the quality of medicines. Methods This study used a descriptive cross-sectional design with both quantitative and qualitative approaches. The quantitative approach used a self-administered questionnaire to collect data from employees of Rwanda FDA who are involved in medicine regulatory practices based on their positions while the qualitative research approach covered a desk review of key regulatory documents. The data collection tool was developed from the World Health Organization (WHO) Global Benchmarking Tool (GBT) for “Evaluation of National Regulatory System of Medical Products Revision VI”. Results Of the 251 WHO sub-indicators assessed, 179 sub-indicators (71%) were fully implemented, 17 sub-indicators (7%) were partially implemented, 9 sub-indicators (4%) were ongoing and 46 sub-indicators (18%) were not implemented by the time of the study. The results of the study showed that the estimated maturity level at which Rwanda FDA operates is maturity level 2. The study reported the challenges hindering the implementation of key regulatory functions that need to be addressed. Challenges reported include but are not limited to understaffing, lack of automation system, poor implementation of the quality management system, lack of screening technologies for SF medicines, low capacity of the quality control laboratory to test all sampled medicines and lack of regulatory inspection tools/equipment. Conclusion Findings indicated that all key regulatory functions were operating and supported by the legal framework. However, the implementation of key regulatory functions faced challenges that need to be addressed for better organizational effectiveness and compliance with the requirements of a higher maturity level.