Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients' Access to Medicines
Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients' Access to Medicines
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DOI：
10.1007/s43441-019-00013-5
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发表时间：
2019-12-12
影响因子：
1.5
通讯作者：
Walker, Stuart
中科院分区：
文献类型：
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作者：
Keyter, Andrea;Salek, Sam;Walker, Stuart
通过建立和完善增值注册流程、资源和系统，提高注册效率和时间表，可以解决及时获得新药的问题。本研究的目的是评估2015-2018年南非审评过程的里程碑时间表和新活性物质（NAS）的总体批准过程，并为通过及时注册改善患者获得新药提供建议。方法收集并分析了2015-2018年期间南非监管局注册的NAS的里程碑和总体批准时间的数据。结果2017年批准的NAS最多（42个），2018年最少（15个）。2015年实现了最短的中位批准时间（1218个日历日），2018年实现了最长的中位批准时间（2124天）。所有申请均采用全面审查程序进行审查，16/99份申请（16%）被指定为优先申请，并通过快速审查获得审查和批准。结论虽然在南非NAS批准的广泛延迟可能是由于效率低下的操作过程中，资源限制，并作为注册申请的数量增加，新成立的南非保健产品监管机构已重新设计和简化其监管审查过程，这已经试行，并将在最终实施前得到加强。在改进建议中，SAHPRA应考虑衡量和监测里程碑，促进监管途径，实施可靠性战略和质量管理体系。
Background Timely access to new medicines may be addressed through strengthening of registration efficiencies and timelines by establishing and refining value-added registration processes, resources, and systems. The aims of this study were to evaluate the timelines of the milestones of the South African review process and the overall approval process for new active substances (NASs) in 2015-2018 and to provide recommendations for improved patients' access to new medicines through timely registration. Methods Data identifying the milestones and overall approval times for NASs registered by the South African Agency during 2015-2018 were collected and analyzed. Results The most NASs (42) were approved in 2017 and the least (15) in 2018. The shortest median approval time (1218 calendar days) was achieved in 2015 and the longest (2124 days), in 2018. All applications were reviewed using the full review process, and 16/99 (16%) were assigned priority status and were reviewed and approved through the fast track review. Conclusions While the extensive delays in NASs approvals in South Africa may be attributed to inefficient operational processes, resource constraints, and as an increased number of applications for registration, the newly established South African Heath Products Regulatory Agency has re-engineered and streamlined its regulatory review process, which has been piloted and will be enhanced prior to final implementation. Among recommendations for improvement, SAHPRA should consider measurement and monitoring of milestones, facilitated regulatory pathways, implementing a reliance strategy, and a quality management system.