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| Benefits of the EAC-MRH initiative.

| Benefits of the EAC-MRH initiative.

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Article
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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, inspec...

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... timelines for approval, information sharing among regulators, and building capacity for assessments were highlighted by all seven authorities as the main benefits of the EAC initiative ( Figure 2). Building capacity for assessments was indicated by all as a considerable benefit, which was especially apparent in less-resourced agencies. ...

Citations

... A study was conducted in 2021 to determine the views of regulators from the seven NMRAs of the EAC-MRH initiative on the effectiveness and efficiency of the work-sharing initiative. One of the recommendations from this study was to conduct a similar study with the applicants, so that there could be a comparison of the benefits and challenges from the point of view of both key stakeholders (Ngum et al., 2022). The aim of this study was, therefore, to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative from the applicants' perspective, including the challenges it faces as well as to identify opportunities for improvement. ...
... Comparing the views of applicants in this study with those of regulators Ngum et al. (2022), identified similar challenges. These included the lack of a centralised submission and tracking process for the work-sharing initiative entailing a lack of clarity about the process for submission and follow-up in each country for applicants. ...
Article
Full-text available
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.
... Following the successful assessment of the ZaZiBoNa and EAC-MRH initiatives in 2021 and the impending launch of the African Medicines Agency, it is timely that the WA-MRH initiative is assessed at this time and hence the implementation of this study (Sithole et al., 2022;Ngum et al., 2022). The study aimed to assess the effectiveness and efficiency of the West Africa Medicines Regulatory Harmonization Initiative by the member countries. ...
... The Process Effectiveness and Efficiency Rating (PEER) Questionnaire, previously developed and validated by Ngum and others to evaluate the performance of the East African Community joint assessment procedure (Ngum et al., 2022), was used to collect the study data. The PEER Questionnaire consists of five categories: 1) Authority resources; 2) Benefits of the WA-MRH initiative; 3) Challenges of the WA-MRH initiative; 4) Improving the performance (effectiveness and efficiency) of the work-sharing programme; and 5) Strategy for moving forward. ...
... A solution for this shortcoming should therefore be given a high priority. Lessons can be taken from the EAC-MRH initiative which has achieved the important benefit of shorter timelines for approval since this was not an outcome for the ZaZiBoNa initiative (Sithole et al., 2022;Ngum et al., 2022). This will enhance the reported benefit of the WA-MRH initiative to patients at the country and regional levels of having quicker access to quality-assured medicines. ...
Article
Full-text available
Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and effective medicines and vaccines by the 15 countries in the Economic Community of West African States region. Although this project has made significant progress towards the realisation of its goals, challenges still remain. The aims of this study were to evaluate the effectiveness and efficiency of the WA-MRH, examine what challenges are being encountered and identify strategies that would strengthen the process for realising the initiative’s goals. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from assessors representing the seven active NMRAs in the joint assessment procedure that identified the benefits, challenges and recommendations for improving the performance of the WA-MRH project. Results: The benefits of the joint assessment procedure include time savings to manufacturers resulting from submitting one dossier and the same response package to multiple countries resulting in access to the multiple African markets within the same timeframe. Additionally, some of the NMRAs have been able to strengthen their technical capacity as a result of this initiative. Key challenges to the project include the lack of a robust information technology system that would enable dossier tracking and constraints in human resources needed to support dossier submissions and the assessment process. Conclusion: This study identified the strengths of the WA-MRH initiative as well as strategies for improvement and achievement of its objectives. The centralised submission of a dossier and its tracking is key to the regulatory assessment process. This research has demonstrated that amongst other considerations, a robust information technology system, coupled with the necessary human resource capacity would greatly enhance the effectiveness and efficiency of the WA-MRH initiative.