Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward

Abstract

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.

Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: 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.…”

“…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.…”

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries

“…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.…”

“…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.…”

“…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.…”