East African Community Secretariat, Arusha, Tanzania.
School of Life and Medical Sciences, University of Hertfordshire, United Kingdom; African Union Development Agency- New Partnership for Africa's Development (AUDA-NEPAD), Johannesburg, South Africa.
Regul Toxicol Pharmacol. 2023 May;140:105383. doi: 10.1016/j.yrtph.2023.105383. Epub 2023 Mar 16.
Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. Measuring the performance of regulatory systems provides key baseline information to build on regulatory system-strengthening strategies. Therefore, the aim of the study was to evaluate the regulatory performance of the EAC joint scientific assessment of applications approved between 2018 and 2021.
Utilising a data metrics tool, information was collected reflecting timelines for various milestones including submission to screening, scientific assessment and communication of regional recommendations for biologicals and pharmaceuticals that received a positive regional recommendation for product registration from 2018 to 2021.
Several challenges as well as possible solutions were identified, including median overall approval times exceeding the EAC 465-day target and median times to issue marketing authorisation following EAC joint assessment recommendation that far exceeded the 116-day target. Recommendations included establishment of an integrated information management system and automation of the capture of regulatory timelines through the EAC metric tool.
Despite initiative progress, work is required to improve the EAC joint regulatory procedure to achieve regulatory systems-strengthening and ensure patients' timely access to safe, efficacious and quality medicines.
东非共同体（EAC）的七个国家药品监管机构通过 EAC 药品监管协调方案，采用监管依赖、协调和工作分担的方式。衡量监管系统的绩效为加强监管系统战略提供了关键的基准信息。因此，本研究旨在评估 2018 年至 2021 年期间批准的联合科学评估申请的 EAC 监管绩效。
利用数据指标工具，收集反映各种里程碑时间线的信息，包括自提交筛选、科学评估到就生物制品和药品发布区域建议的各个阶段，这些药品在 2018 年至 2021 年期间收到了来自区域的产品注册积极建议。
确定了几个挑战以及可能的解决方案，包括总体批准时间中位数超过 EAC 465 天的目标，以及在 EAC 联合评估建议后发布营销授权的时间中位数远远超过 116 天的目标。建议包括建立一个综合信息管理系统，并通过 EAC 指标工具实现监管时间线的自动化捕获。
尽管取得了初步进展，但仍需要努力改进 EAC 联合监管程序，以加强监管系统，并确保患者能够及时获得安全、有效和高质量的药物。
