Ngum Nancy, Mashingia Jane, Ndomondo-Sigonda Margareth, Walker Stuart, Salek Sam
Department of Clinical and Pharmaceutical Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
African Union Development Agency, New Partnership for Africa's Development (AUDA-NEPAD), Johannesburg, South Africa.
Front Pharmacol. 2022 Jul 5;13:891506. doi: 10.3389/fphar.2022.891506. eCollection 2022.
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. 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. 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. 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.
近十年来，东非共同体在其成员国中实施了药品监管协调（EAC-MRH）计划，以协调医疗产品监管的技术要求和标准，联合对医疗产品档案进行科学审查，以评估安全性、有效性和质量，检查药品生产场地并简化决策流程。该举措能够确定有限资源的成本效益利用方式以及监管服务的高效交付方式，从而在所有利益相关者中树立透明度和问责制，优化药品市场和经济发展，并改善该地区安全、高质量、有效药品的可及性。本研究的目的是评估EAC-MRH计划当前运营模式的有效性和效率，包括所面临的挑战，并确定改进机会。在联合评估程序中，代表东非共同体七个机构的评估人员完成了用于确定EAC-MRH计划绩效的益处、挑战和改进建议的过程有效性和效率评级（PEER）问卷。还进行了半结构化访谈以验证答复。该计划具有相当大的价值，因为它朝着实现其主要目标迈进，即缩短药品批准时间、监管机构之间共享信息以及进行评估能力建设，从而使该地区的患者能够更快获得药品且药品供应增加。然而，已确定的阻碍有效性和效率的关键挑战包括缺乏集中提交和跟踪系统；人力资源不足；制造商未向所有相关国家提交完全相同的档案；缺乏综合信息管理系统；国家药品监管机构或东非共同体网站上缺乏信息；以及监测和跟踪评估报告方面的挑战。使用强大的信息技术系统对东非共同体产品进行集中跟踪对于应对已确定的挑战并提高监管有效性和效率至关重要。需要一个中央支付点来加快流程，并确保国家和地区网站上决策信息的透明度和可获取性。其他关键的改进策略包括提高评估人员的能力、工作和信息共享以及区域联合评估的协调机制，最终建立一个区域药品机构。
