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S135: Evaluation of the Effectiveness and Efficiency of Ten Years’ Experience with the East African Community Joint Assessment

Poster Presenter

Nancy Biyeah Yang Ngum

Student
University of Hertfordshire
United Kingdom

Objectives

To evaluate the effectiveness and efficiency of the current East African Community Medicines Regulatory Harmonization (EAC-MRH) operating model, from both the regulators and applicants’ perspective. This included identifying the benefits, challenges, and opportunities for improvement.

Method

The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to identify the benefits and challenges for improving the performance of the EAC initiative. This was completed by seven EAC assessors and 14 pharmaceutical companies coupled with Semi-structured interviews.

Results

The East African Community Medicines Regulatory Harmonization (EAC-MRH) regional initiative consists of seven agencies, namely Burundi, Kenya, Uganda, Rwanda, South Sudan, Tanzania and Zanzibar. It has been of considerable value since it was established in 2009 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. Pharmaceutical companies outlined how the initiative 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. However, the key challenges identified by the agencies in the Region that have hindered the expected effectiveness and efficiency of this initiative were the lack of a centralised submission and tracking system; a lack of mandated registration; inadequate human resources, manufacturers’ failure to submit the exact same dossier to all countries of interest; a lack of an integrated information management system; a lack of information on national medicines regulatory authority or EAC websites; and challenges in monitoring and tracking assessment reports. A key strategy proposed by both agencies and applicants was 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

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. To expedite the process and to ensure transparency, information on decision making should be available on national and regional websites. 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. As this is the first study evaluating the performance of the EAC work sharing initiative, it was believed that the system performs efficiently. However, in some member countries an EAC positive recommendation does not directly result in an individual country approval. If the recommendations are implemented, then this should facilitate the overall goal of the initiative to expedite the availability of quality-assured medicines to patients in the region. While harmonisation is key to ensuring access to safe, effective, and high-quality medicines, accessibility and affordability also need to be addressed to realise the full benefits of the medicines regulatory harmonisation initiative. Full implementation of the EAC road map 2020–2022 is critical to address such issues. Rwanda, one of the EAC member countries, will be hosting the African Medicines Agency and with the combined efforts by the African Union Partners, with the support of the EAC work sharing initiative, will strengthen regulatory systems on the continent. The recommendations from this study included measuring and monitoring timelines, the availability of submission guidelines, the training and capacity building of regulatory reviewers as well as the publication of decision-making outcomes. If these recommendations are implemented, it is believed it will improve the effectiveness and efficiency of this regional initiative