Fig 3 - available via license: CC BY
Content may be subject to copyright.
The joint good manufacturing process inspection pathway of the EAC's Medicines Regulatory Harmonization initiative. EAC, East African Community; NMRA, national medicines regulatory authority. https://doi.org/10.1371/journal.pmed.1003134.g003

The joint good manufacturing process inspection pathway of the EAC's Medicines Regulatory Harmonization initiative. EAC, East African Community; NMRA, national medicines regulatory authority. https://doi.org/10.1371/journal.pmed.1003134.g003

Source publication
Article
Full-text available
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 Medi...

Context in source publication

Context 1
... SOPs were used during the 15 joint GMP inspections conducted thus far, resulting in 14 joint recommendations for approval. Similar to joint product assessments, joint GMP inspections are assigned to inspectors from 2 NMRAs, who share their findings with the EAC's other NMRAs via the GMP Inspection Working Group (Fig 3). Most joint inspections have been performed on facilities that produce low-cost generic medicines. ...

Similar publications

Article
Full-text available
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...

Citations

... The attainment of International Standard (ISO) certification especially ISO-9001 Quality management systems-Requirements by the National Medicines Regulatory Authority is an indicator of a well-functioning regulatory authority [20]. Interestingly, the management has appointed QMS focal persons in each division/unit. ...
Full-text available
Article
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.
... As the first region to implement medicines regulatory harmonisation in Africa, the EAC has made major strides toward achieving its main objective of improving patients' access to high-quality medicines in the region. The EAC-MRH initiative has made the process of registration and marketing authorisation more efficient to pharmaceutical companies through the use of harmonised technical standards and optimisation of regulatory requirements, thereby resulting in the reduction of timelines for review of applications (Mashingia et al., 2020;Ndomondo-Sigonda et al., 2020). ...
Full-text available
Article
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.
... In particular, the East African Community Medicines Regulation Harmonisation (EAC MRH) Programme will likely facilitate similar access initiatives, expanded at a regional level. 6 Technology transfer In sub-Saharan Africa, up to 90% of medicines are imported, which is associated to common stockouts and shortages. 1 Technology transfer is a powerful strategy for sustainable access to medicines, but not frequently implemented for antimicrobials. ...
... With the launch of the EAC-MRH programme, the EAC authorities have made substantial progress in reducing timelines for registration of medical products using the joint review process. A study of the EAC-MRH pilot phase (2012-2017) by Mashingia and colleagues found that registration timelines were reduced from 24 months to 8-12 months for products reviewed using this process (Mashingia et al., 2020). ...
... The median time for joint assessment in 2019 was reported to have decreased to 240 working days, demonstrating that the EAC joint assessment process was becoming more efficient (Mashingia et al., 2020). In the same study, registration timelines at the national level were reduced from 24 months to 8-14 months during the 2012-2017 time period (Mashingia et al., 2020). ...
... The median time for joint assessment in 2019 was reported to have decreased to 240 working days, demonstrating that the EAC joint assessment process was becoming more efficient (Mashingia et al., 2020). In the same study, registration timelines at the national level were reduced from 24 months to 8-14 months during the 2012-2017 time period (Mashingia et al., 2020). Giaquinto and colleagues also confirmed that one of the strengths of this initiative was the implementation of the joint assessment and work-sharing procedure with the introduction of the submission of one dossier by applicants to all EAC authorities (Giaquinto et al., 2020). ...
Full-text available
Article
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.
... 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]. ...
... This regional initiative also designed a twinning system for capacity building. EAC Member States with less mature regulatory systems were paired with more established NRAs, i.e., Zanzibar's NRA was paired with Kenya's, Burundi's with Tanzania's, and Rwanda's with Uganda's [45,46]. "Healthy cooperation and friendly competition" between NRAs enables high quality and consistent assessments, as well as ensures that assessors are continuously upskilled [48]. ...
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.
... The World Health Organization (WHO) prequalification "Guidelines for submission of documentation for a multisource (generic) finished product and preparation of product dossiers in common technical document format" (6) have been adapted or adopted for use by many low-and middle-income countries in the last decade. The CTD format has facilitated harmonisation of medicines registration requirements, work sharing and joint reviews on the African continent (7,8) as is the case in other emerging markets (5,9). Established in 2009, the African Medicines Regulatory Harmonisation Initiative (AMRH) is the driving force behind harmonisation of medicines regulation in Africa (10). ...
Full-text available
Article
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.
... The EAC MRH initiative was innovative in many ways, particularly in its decentralized structure, emphasis on work-sharing, and regulation through reliance driven by trust and goodwill. In the next paper in this Collection, "Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned" [18], we will describe what this innovative approach allowed the initiative to accomplish, including its most significant achievements and its biggest challenges. ...
Full-text available
Article
Background Immunization is a cost-effective public health strategy to reduce vaccine preventable disease, especially in childhood. Methods This paper reports the philosophy, service delivery, achievements and lessons learned from an immunization program in rural Nigeria privately financed via a corporate social responsibility initiative from GlaxoSmithKline Biologicals. Results The immunization program served the community for a 16-y period extending from 1998 until 2015, resulting in an increase in age-appropriate immunization coverage from 43% to 78%. Conclusion In its success, this immunization program exemplified the importance of early and sustained community engagement, integration of strategies to optimize implementation outcomes and effective team building well before some of these principles were accepted and codified in the literature. The project also underscores the important role that the private sector can bring to achieving critical immunization goals, especially among underserved populations and provides a model for successful public-private partnership.
... Work-sharing or joint reviews involves the participation of 2 or more regulatory agencies such as the Southern African Development Community (SADC) 13 and the East African Community. 14 The global access mechanisms such as EUM4All 15 or the Swissmedic Marketing ...
Full-text available
Article
There is a critical skills gap on the African continent in regulatory sciences, and an acknowledged need to develop a long‐term strategy for training and professional development of African regulatory personnel. Capacity building programs for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever‐expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients. Monitoring and evaluation of capacity development interventions will be essential to show value of investments and ultimately guide continued funding and sustainability. This paper reviews the skills and human capacity gaps, reports on regulatory assessment pathways used in Ghana, South Africa and Zimbabwe and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.
... 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. ...
Full-text available
Article
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.
... The International Standards Organization (ISO) certification is a globally recognized accreditation of the maturity and functionality of the QMS of an organization. [36]. ...
... The EAC regulatory harmonization experience has enhanced regulatory science by increasing the rigour of the review process, with subsequent higher quality standards than national procedures. In turn, this has reduced the overall regulatory burden and led to less duplication of efforts [36,39,40]. These contribute to the strengthening of the capacity of the NMRAs in expedition of the assessments of priority medicines and filtering out of substandard or falsified products [38]. ...
... With a resultant increase in the number of received applications as observed in Kenya, Tanzania Key: ✓ = fully functional; ✓✓ = fully functional and integrated to National Revenue Authority; ✓✓✓ = fully functional and integrated to e-banking and/or Mobile money; ✓✓✓✓ = fully functional and reports customized according to the national and regional needs; ✕ = non-functional; NA = not applicable (Source: EAC Secretariat MRH Project Progress Report, 2015 mainland and Uganda. The ISO certification will also increase confidence in the quality of NMRAs work, increasing trust and facilitate reliance on registration and inspection processes as viewed by peer agencies in the region and across the continent [36]. It is important to note that ISO certification of the NMRAs is one of drivers of a robust medicines regulatory system. ...
Full-text available
Article
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.