An Evaluation of the Regulatory Review Systems in the East African Community: Contributing to the Establishment of the African Medicines Agency

Abstract

The African Medicines Agency (AMA) has been established as the main driver for “enhancing the regulatory oversight of medicines and vaccines across the African continent”. A successful AMA will need strong and agile NRAs and REC-MRH programmes/ authorities to address most of the regulatory challenges. It is therefore critical to evaluate the regulatory review systems and performance of the regional medicines harmonisation progress to determine their capacity to fully support the AMA. The aim of this research programme was to evaluate the regulatory review systems in the East Africa Community as it contributes to the establishment of the African Medicines Agency. This started with an overview of the EAC medicines regulatory landscape where the history, objectives, scope, organisational structure, successes and benefits of the EAC-MRH was obtained from existing literature. This was followed by an assessment of the review systems of the seven NRAs in the EAC region, using an established standardised questionnaire, (Optimising the Efficiency of Regulatory Agencies), which captures review processes was completed by the Head of the medicine’s registration division in each of the seven NRAs. A country report based on the completed questionnaire for each NRA was validated by the heads of the respective agencies. The Process Effectiveness and Efficiency Rating (PEER) questionnaire was then used to evaluate the effectiveness and efficiency of the current East African Community Medicines Regulatory Harmonization (EAC-MRH) operating model, and was completed by seven EAC assessors and 14 pharmaceutical companies coupled with Semi-structured interviews Lastly, using existing literature, a comparison of the outcome of this study on the EAC-MRH was conducted with the Southern African Community Regional Initiative (ZaZiBoNa) and the West African Community (WAC)-MRH initiative to learn best practices and share experience. The results of this study on the evaluation of the effectiveness and efficiency of the EAC regional initiative, indicated that the approach has been of considerable value since its inception in 2012 as it moves towards achieving its main objectives of 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. However, the key challenges identified by the agencies in the Region which 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. Good Review Practices of agencies in the East African Medicine Regulatory Harmonisation Initiative could still be improved. This study has demonstrated how the EAC-MRH performs regulatory reviews in order to improve the capacity of NRAs. For the AMA to be successful, country regulatory processes need to be streamlined and differences in country requirements minimised. 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. 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 centralised procedure is critical to address such issues. 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 and the implementation of a central submission and tracking system. If these recommendations are implemented, it should improve the effectiveness and efficiency of this regional initiative and thus support the African Medicines Agency .