Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Unit G3: International Coordination/Regulatory Services, Paul-Ehrlich Str. 51-59, 63225, Langen, Germany.
Paul-Ehrlich-Institut, Global Health Protection Programme (GHPP) RegTrain-VaccTrain, Langen, Germany.
Global Health. 2022 Jun 20;18(1):63. doi: 10.1186/s12992-022-00854-0.
A stable, well-functioning and integrated national medicines regulatory system is a core component of health systems resilient against infectious disease outbreaks. In many low- and middle-income countries, however, sizable gaps exist in the emergency preparedness framework of national regulatory authorities (NRAs). RegTrain-VaccTrain is a project of Germany Ministry of Health's Global Health Protection Programme that contributes to global efforts aimed at strengthening such regulatory systems by providing technical support and advice to partner NRAs. In this study, we probed the outputs of our capacity-strengthening activities for clinical trials oversight (CTO) to take stock of progress made and examine remaining priorities in order to provide specialized technical assistance in addressing them to improve operational readiness for emergencies.
Data validated from NRA self-benchmarking results in 2017 and worksheet records of November 2021 were utilized to assess the emergency preparedness capacity for CTO in three VaccTrain partner NRAs (Liberia, Sierra Leone, The Gambia) before and after interventional capacity-strengthening partnership, using specific public health emergency-related (sub-)indicators of the WHO Global Benchmarking Tool.
A generally weak and vulnerable structural framework for CTO characterized the emergency preparedness capacity in all three partner NRAs at baseline, thus putting their operational readiness for public health emergencies at risk. VaccTrain's collaborative work was successful at supporting individual NRAs to develop the full spectrum of operational structures (including (draft) regulations, guidelines, and standard operating procedures) required to improve regulatory preparedness. A gap in the formal approval and implementation of developed legal documents in two of three NRAs still remains. Notwithstanding, a robust emergency framework now exists and the NRAs stand better prepared to respond to (future) locally-concerning health emergencies, during which time clinical trials activity was observed to heighten.
These results exemplify a north-south capacity-strengthening partnership model that effectively contributes in developing structures to enhance regulatory oversight and support expeditious product development in response to crises. They further underscore the equally critical role local/national processes play in facilitating the full implementation of developed structures.
一个稳定、运作良好且整合的国家药品监管体系是应对传染病疫情的卫生系统的核心组成部分。然而，在许多中低收入国家，国家监管机构（NRA）的应急准备框架仍存在较大差距。RegTrain-VaccTrain 是德国卫生部全球卫生保护计划的一个项目，通过向合作伙伴 NRA 提供技术支持和建议，为加强此类监管系统的全球努力做出贡献。在这项研究中，我们探讨了我们加强临床试验监督（CTO）能力建设活动的产出，以评估进展情况并检查剩余的优先事项，以便提供专门的技术援助来解决这些问题，提高应对紧急情况的运作准备。
利用 NRA 2017 年自我基准测试结果和 2021 年 11 月工作表记录的数据进行验证，使用世卫组织全球基准工具的特定与公共卫生应急相关的（分）指标，在干预前和干预后评估三个 VaccTrain 合作伙伴 NRA（利比里亚、塞拉利昂、冈比亚）的 CTO 应急准备能力。
在基线时，所有三个合作伙伴 NRA 的 CTO 应急准备能力都表现出结构框架薄弱和脆弱的特点，这使其应对公共卫生紧急情况的运作准备处于风险之中。VaccTrain 的合作工作成功地支持了各个 NRA 发展改进监管准备所需的全方位运作结构（包括（草案）法规、准则和标准作业程序）。在三个 NRA 中的两个中，仍存在制定的法律文件正式批准和实施方面的差距。尽管如此，现在已经建立了一个强大的应急框架，NRA 更有能力应对（未来）当地关注的卫生紧急情况，在此期间观察到临床试验活动有所增加。
这些结果例证了南北合作的能力建设伙伴关系模式，有效地为加强监管监督和支持快速产品开发应对危机提供了结构。它们进一步强调了地方/国家进程在促进充分实施制定的结构方面同样至关重要的作用。
