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Comparison of regulatory agency total staff numbers, as of 2013 a .

Comparison of regulatory agency total staff numbers, as of 2013 a .

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Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need. • Several factors determine access to medicines, including treatment policy, pr...

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... EAC NMRAs were severely understaffed (Table 1). For example, Kenya and Uganda each had 11 qualified staff evaluators; Rwanda and Zanzibar each had only 2. ...

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... Study participants were distributed into three categories; Generics (foreign); that is, applicants who manufacture generic medicines outside of the EAC region, Generics (local); that is, applicants who manufacture generic medicines within the EAC region, and Innovators; that is, applicants who submitted applications for registration of innovator medicines. During the period of study (2015)(2016)(2017)(2018)(2019)(2020)(2021), there were no local innovators that submitted applications for innovator medicines for registration. ...
... Adherence to the EAC-MRH process by the NMRAs should be promoted. Arik and others also recommended a cooperation framework agreement between NMRAs and the EAC (2020). Instituting a legally binding framework would enhance implementation of joint decisions (Giaquinto et al., 2020) and one of the study participants further suggested the elimination of national assessments of dossiers. ...
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Background: A 2021 study to determine the viewpoints among the seven member countries regarding the effectiveness (i.e., achieving the intended outcomes) and efficiency (i.e., achieving the intended outcomes in timely manner with the resources available) of the East African Community Medicine Regulatory Harmonisation (EAC-MRH) Joint Assessment Procedure recommended the conduct of a similar study among pharmaceutical company applicants. The aim of this study then was to evaluate the effectiveness and efficiency of the current EAC-MRH operating model from the applicants’ perspective, including the challenges and opportunities for improvement. Methods: Using the Process Effectiveness and Efficiency Rating for Industry questionnaire developed by the authors, data were collected from company representatives responsible for EAC joint procedure submissions. Results: Responses from 14 study participants underlined the support of pharmaceutical companies for the EAC-MRH initiative, which has facilitated the harmonisation of registration requirements across the EAC region leading to one registration for all countries and a reduction of the workload for both applicants and assessors. In addition, it is expected that shorter timelines for approval will lead to improved access to quality-assured essential medicines in the region. Access to various markets at the same time was also noted as an important benefit to pharmaceutical companies. Noted challenges include a lack of process information, a lack of centralised submission and tracking process and a lack of mandated central registration. A key strategy proposed by participants is the establishment of a regional administrative body to centrally receive and track EAC applications and the eventual establishment of a Regional EAC Medicines Authority. Conclusion: This is the first study evaluating the performance of the EAC work-sharing initiative from the point of view of the applicants. In general, the applicants believe that the system performs efficiently and fulfils its promise. However, some participants indicated that in some countries an EAC positive recommendation does not directly result in an individual country approvals. Following the recommendations listed in this report may mitigate identified areas for improvement and facilitate the overall goal of the EAC-MRH initiative to expedite the availability of needed quality-assured medicines to patients in the region.
... Given the capacity differences in regulating medical products in African Member States, it is important to note that the African Union (AU) Member States and Regional Economic Communities (RECs) are making significant efforts to improve access to safe, quality, and efficacious medical products through strengthening and harmonising medicines regulatory systems. Studies show that the reluctance from companies manufacturing medical products to register their products in African markets is one of the major factors delaying access to medicines (Sillo et al., 2020). Reasons for this reluctance is due to the lengthy application process, the time, expense, and effort needed for this registration process in each NRA (Sillo et al., 2020). ...
... Studies show that the reluctance from companies manufacturing medical products to register their products in African markets is one of the major factors delaying access to medicines (Sillo et al., 2020). Reasons for this reluctance is due to the lengthy application process, the time, expense, and effort needed for this registration process in each NRA (Sillo et al., 2020). To improve access to safe, quality and effective medical products, the EAC joint assessment project was established in 2012, to assist in facilitating the market authorisation application process for manufacturers through a faster review of applications in the region. ...
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Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspect pharmaceutical manufacturing sites and streamline decision-making processes. This initiative enables the cost-effective use of limited resources and efficient and effective delivery of regulatory services to be determined, thus instilling transparency and accountability in all stakeholders, optimising the pharmaceutical market and economic development and improving access to safe, high-quality, effective medicines in the region. The aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative, including challenges faced and to identify opportunities for improvement. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire, which was used to identify the benefits, challenges, and suggestions for improving performance of EAC-MRH initiative, was completed by assessors representing seven EAC authorities in the joint assessment procedure. Semi-structured interviews were also carried out to validate the responses. Results: This initiative has been of considerable value as it moves toward achieving its main objectives of shorter timelines for approval of medicines, information sharing among regulators and capacity building for assessments, resulting in quicker access and increased availability of medicines for patients in the region. However, the key challenges identified that have hindered effectiveness and efficiency were the lack of a centralised submission and tracking system; inadequate human resources, manufacturers’ failure to submit the exact same dossier to all countries of interest; lack of an integrated information management system; lack of information on national medical regulatory authority or EAC websites; and challenges in monitoring and tracking assessment reports. Conclusion: The use of a robust information technology system for the central tracking of EAC products is essential to address the identified challenges and improve regulatory effectiveness and efficiency. One central point for payment is needed to expedite the process and to ensure transparency and the availability of information on decision making on national and regional websites. Other key strategies for enhancement include improving the capacity of assessors, work and information sharing and a coordination mechanism for the regional joint assessment, with the eventual establishment of a regional medicine agency.
... Every country should ensure an adequate supply of safe, efficacious, good quality, and affordable medical products to promote public health [3].Effective regulatory systems ensure that the medical products meet the recommended standards to protect and promote public health [4,5]. All countries globally are encouraged to have functional, effective, and efficient National Regulatory Authorities (NRAs) [6]. However, at least 30% of the existing NRAs have constrained capacity to perform core regulatory functions [7,8]. ...
... Our study focused on the regulation of unregistered medicines, an area often neglected and not fully addressed in ongoing efforts to strengthen regulatory systems. Nonetheless, the results are consistent with previous reports; for example, the estimates that only 30% of NRAs among SADC Member States can effectively and efficiently regulate medical products in their countries [36].The results are also consistent with other studies that observed that legal frameworks lacked or were fragmented in most African countries [2,6] Additionally, some studies have shown that implementing medicines control regulation on the importation, use, and reporting of adverse drug reactions in developing countries is by far still too low compared to the levels in high-income countries [37,38]. This may result in NRAs in SADC, or similar settings, allowing the importation of medicines whose quality is unknown and not being adequately assessed. ...
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Background The purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries. Methods The study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package. Results Approximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4 to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively. Conclusion Implementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.
... One of the benefits of regulatory harmonisation is that it facilitates ongoing capacity building by having assessors engage in peer learning and receiving feedback [9]. This is evident in Africa where regional medicines regulatory harmonisation (MRH) initiatives started with the EAC, which consists of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda [9,10,45,46]. The EAC MRH initiative was officially launched on 30 March 2012 in Arusha, Tanzania with the goal of improving its citizen's access to quality-assured, safe and efficacious essential medical products for the treatment of conditions that have public health importance [4,9,10,13,15,[45][46][47]. ...
... This is evident in Africa where regional medicines regulatory harmonisation (MRH) initiatives started with the EAC, which consists of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda [9,10,45,46]. The EAC MRH initiative was officially launched on 30 March 2012 in Arusha, Tanzania with the goal of improving its citizen's access to quality-assured, safe and efficacious essential medical products for the treatment of conditions that have public health importance [4,9,10,13,15,[45][46][47]. When the EAC MRH project started, it relied on a Steering Committee, Technical Working Groups (TWGs), and a Project Coordination team to assist it perform its functions [46]. ...
... The EAC MRH initiative was officially launched on 30 March 2012 in Arusha, Tanzania with the goal of improving its citizen's access to quality-assured, safe and efficacious essential medical products for the treatment of conditions that have public health importance [4,9,10,13,15,[45][46][47]. When the EAC MRH project started, it relied on a Steering Committee, Technical Working Groups (TWGs), and a Project Coordination team to assist it perform its functions [46]. The Steering Committee was composed of Heads of EAC NRAs, chief pharmacists, the EAC Secretariat, and AMRH initiative partners [46]. ...
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.
... Challenges ahead include shifting from donor support to becoming self-sustained, optimizing the cooperation between NRAs with very different levels of resources and experience, and moving toward a more transparent system that is easier to navigate. 23 Regulatory harmonization is growing in the African context, characterized hitherto by variable regulatory capacities 24 and a high prevalence of SF medicines (estimated at 19%, while 42% of the reports of SF products submitted to WHO between 2013 and 2017 come from this region). 7 In 2009, the African Medicines Regulatory Harmonization initiative was launched to create more effective, efficient, and transparent regulatory mechanisms across the continent. ...
Article
In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.
... • In the first paper of the Collection [15], individuals who have been involved with the program since the beginning explain how the initiative started. ...
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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.
... As described in an accompanying article in this collection, Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative [6], the overarching vision of the EAC's MRH initiative was to increase the number of quality medicines registered in the region by (1) simplifying the application process for manufacturers and (2) increasing the efficiency with which applications were assessed by Partner States-without sacrificing product efficacy, safety, or quality. In pursuit of this vision, the initiative originally decided to focus on • Building the EAC's regional and national capacity to implement registration processes and harmonize and align technical standards; and ...
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. ...
... When the EMA was founded, its Secretariat consisted of only 16 people. The current structure of the EAC MRH initiative, which appears to contain multiple levels of hierarchy and a large number of individuals [2], may hamper its ability to make decisions quickly and respond to problems in an agile manner. Perhaps, in establishing the planned EAC Medicines Agency, the EAC can reduce bureaucratic barriers to action. ...
... Currently with the aim to strengthen national regulatory capacity in LMICs, the WHO has developed a Global Benchmarking Tool (GBT) to facilitate coordination, regulatory resilience and harmonization and improve effectives of strengthening efforts [213]. In LMICs, harmonization of technical requirements, regulatory process optimization, regional cooperation is suggested as vital step forward in ensuring access to quality medicines and save economy [214,215]. ...