A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency.
A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency.
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DOI：
10.34172/ijhpm.2020.213
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发表时间：
2022-06-01
影响因子：
3.5
通讯作者：
Walker, Stuart
中科院分区：
文献类型：
--
作者：
Keyter, Andrea;Salek, Sani;Banoo, Shabir;Walker, Stuart
背景：各种规模和成熟度的国家监管机构，包括南非保健品监管局（SAHPRA），不得不修改系统并重新设计流程，以适应新的监管环境并提高监管操作的有效性。本研究旨在以支持加强监管体系的世界卫生组织全球基准工具（WHO GBT）参数为基础，开发一种新的监管审查模型，以改善监管绩效。方法：基于作者先前进行的6项研究的关键建议，开发了一个新的增强的监管审查模型，这些研究被认为是提高监管绩效的基本要素。通过整合世卫组织GBT的参数，选定用于定义新的监管审查模式的要素得到认可，这些参数在纳入监管系统后，将支持加强监管绩效。结果：确定了监管绩效改进的机会，并包括质量措施；监督和评估复习时间；基于风险的评估；透明度和沟通；培训和教育。提出了一个改进的南非监管审查和效益风险评估模型，并提出了应用风险分层战略、加强依赖网络、加强良好监管做法和提高透明度的建议。结论：如果得到实施，拟议的改进的监管模式可能为南非实现更高效、更透明、更精简的审查过程铺平道路，同时增加一致性、循证决策实践、缩短时间表和改善患者获得新药的机会。
Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new regulatory review model for improved regulatory performance, underpinned by the parameters of the World Health Organization Global Benchmarking Tool (WHO GBT) that support strengthening of regulatory systems. Methods: A new enhanced model for regulatory review, was developed based on the key recommendations from 6 studies, previously conducted by the authors, that were identified as fundamental elements in enhancing regulatory performance. The elements selected to define the new regulatory review model were endorsed through the integration of the parameters of the WHO GBT that, when embedded within regulatory systems, support enhanced regulatory performance. Results: Opportunities for improvement in regulatory performance were identified and include quality measures; monitoring and evaluating review times; a risk-based evaluation; transparency and communication; and training and education. An improved model for the South African regulatory review and benefit-risk (BR) assessment supported by quality decision-making was proposed as well as recommendations for the application of risk-stratification strategies, strengthening of reliance networks, reinforcing good regulatory practices (GRPs) and enhancing transparency. Conclusion: If implemented the proposed improved regulatory model may pave the way towards more efficient and transparent, streamlined review processes, coupled with increased consistency, evidence-based decision-making practices, reduced timelines and improved patients’ access to new medicines in South Africa.
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影响因子：
5.6
作者：
Bujar M;McAuslane N;Walker SR;Salek S
通讯作者：
Salek S
影响因子：
5.6
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1.5
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通讯作者：
Walker, Stuart
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Keyter, Andrea;Salek, Sam;Walker, Stuart
通讯作者：
Walker, Stuart
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作者：
Ndomondo-Sigonda, Margareth;Miot, Jacqueline;Kaale, Eliangiringa
通讯作者：
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