Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement

Abstract

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.

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry

“…Some of the challenges of the ECOWAS-MRH initiative namely, lack of centralised submission and tracking which were identified by the applicants in the study were also identified by the NMRAs in the previous study ( Owusu-Asante et al, 2022 ). Similar to the studies conducted with regard to the EAC-MRH and ZaZiBoNa ( Ngum et al, 2022 ; Sithole et al, 2022 ), these challenges were also reported with regard to the respective regional MRH initiatives. In addition, the applicants in this study identified other challenges that were specific to the ECOWAS-MRH initiative such as differences in regulatory performance of the countries and dependence on the countries’ process for communication with applicants, and lack of detailed information on the process for applicants.…”

“…Data for the study were obtained through completion of the Process Effectiveness and Efficiency Rating (PEER) questionnaire ( Ngum et al, 2022 ; Sithole et al, 2022 ) by applicants between October 2022 and January 2023.…”

“…About a decade ago, Narsai and colleagues reported that there was inadequate information in the literature detailing the views of pharmaceutical manufacturers about the regulatory systems in Africa ( Narsai et al, 2012 ). This situation has now seen some improvement, following studies published in 2022 by Sithole and colleagues with reference to the ZaZiBona initiative ( Sithole et al, 2022 ) and also by Ngum and colleagues regarding the East African Community initiative ( Ngum et al, 2022 ). More studies should therefore be conducted and published so that much-needed data become available to all stakeholders.…”

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements

“…There are also varying national requirements following the JAP decision ( 11 , 18 ). Examples include the need to submit the full dossier with application to each of the NRAs following JAP opinion, to provide additional national-specific parts of the application not required with JAP, and to start the national procedure de novo ( 7 , 19 ).…”