Owusu-Asante Mercy, Darko Delese Mimi, Walker Stuart, Salek Sam
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
Food and Drugs Authority, Accra, Ghana.
Front Pharmacol. 2022 Nov 25;13:1069345. doi: 10.3389/fphar.2022.1069345. eCollection 2022.
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. 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. 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. 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.
西非卫生组织于2017年启动了西非药品监管协调项目（WA-MRH），其总体目标是提高西非国家经济共同体地区15个国家高质量、安全和有效药品及疫苗的可及性。尽管该项目在实现其目标方面取得了重大进展，但挑战依然存在。本研究的目的是评估WA-MRH的有效性和效率，审视所遇到的挑战，并确定能够加强实现该倡议目标进程的策略。采用过程有效性和效率评级（PEER）问卷，从代表联合评估程序中七个活跃的国家药品监管机构（NMRAs）的评估人员那里收集数据，该联合评估程序确定了WA-MRH项目的益处、挑战及改进建议。联合评估程序的益处包括，制造商因向多个国家提交一份档案和相同的回复文件包而节省时间，从而能在同一时间段进入多个非洲市场。此外，一些国家药品监管机构因这一倡议而增强了其技术能力。该项目的主要挑战包括缺乏一个强大的信息技术系统来实现档案追踪，以及在支持档案提交和评估过程所需的人力资源方面存在限制。本研究确定了WA-MRH倡议的优势以及实现其目标的改进策略。集中提交档案及其追踪是监管评估过程的关键。这项研究表明，除其他考虑因素外，一个强大的信息技术系统，再加上必要的人力资源能力，将大大提高WA-MRH倡议的有效性和效率。
