Moeti Lerato, Litedu Madira, Joubert Jacques
South African Health Products Regulatory Authority (SAHPRA), Kirkness Street, Arcadia, Pretoria, 0007, South Africa.
School of Pharmacy, University of the Western Cape, Robert Sobukwe Road, Bellville, Cape Town, 7535, South Africa.
J Pharm Policy Pract. 2023 Mar 2;16(1):34. doi: 10.1186/s40545-023-00537-0.
Various regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The objective of this study is to critically assess the registration process utilised by SAHPRA between 2011 and 2022 and determine the fundamental root causes for the formation of a backlog. The study also aims to detail the remedial actions that were undertaken which resulted in the development of a new review pathway termed the risk-based assessment approach for regulatory authorities experiencing backlogs to implement.
A sample of 325 applications was used to evaluate the end-to-end registration process employed for the Medicine Control Council (MCC) process between 2011 and 2017; 129 applications were used for the backlog clearance project (BCP) between 2019 and 2022; 63 and 156 applications were used for the risk-based assessment (RBA) pilot studies in 2021 and 2022, respectively. The three processes are compared, and the timelines are discussed in detail.
The longest median value of 2092 calendar days was obtained for the approval times between 2011 and 2017 using the MCC process. Continuous process optimisation and refinement are crucial to prevent recurring backlogs and hence implementation of the RBA process. Implementation of the RBA process resulted in a shorter median approval time of 511 calendar days. The finalisation timeline by the Pharmaceutical and Analytical (P&A) pre-registration Unit, which conducts the majority of the evaluations, is used as a tool for the direct comparison of the processes. The finalisation timeline for the MCC process was a median value of 1470 calendar days, the BCP was 501 calendar days and the RBA process phases 1 and 2 were 68 and 73 calendar days, respectively. The median values of the various stages of the end-to-end registration processes are also analysed in order to build efficiency within the process.
The observations from the study have identified the RBA process which can be implemented to reduce regulatory assessment times while assuring the timeous approval of safe and effective, quality medicines. The continuous monitoring of a process remains one of the critical tools required to ensure the effectiveness of a registration process. The RBA process also becomes a better alternative for generic applications that do not qualify to undergo the reliance approach due to its drawbacks. This robust procedure can therefore be utilised by other regulatory agencies that may have a backlog or want to optimise their registration process.
多个监管机构面临申请积压的情况，这导致患者获得药品的时间延迟。本研究的目的是严格评估南非卫生产品监管局（SAHPRA）在2011年至2022年期间使用的注册流程，并确定积压形成的根本原因。该研究还旨在详细说明所采取的补救措施，这些措施促成了一种新的审评途径的开发，即基于风险的评估方法，供面临积压的监管机构实施。
选取325份申请样本，用于评估2011年至2017年期间药品控制委员会（MCC）流程所采用的端到端注册流程；129份申请用于2019年至2022年期间的积压清理项目（BCP）；63份和156份申请分别用于2021年和2022年的基于风险的评估（RBA）试点研究。对这三个流程进行比较，并详细讨论时间线。
2011年至2017年期间使用MCC流程的批准时间中位数最长，为2092个日历日。持续的流程优化和改进对于防止积压再次出现以及因此实施RBA流程至关重要。RBA流程的实施使批准时间中位数缩短至511个日历日。进行大部分评估的药品与分析（P&A）预注册部门的完成时间线被用作直接比较各流程的工具。MCC流程的完成时间中位数为1470个日历日，BCP为501个日历日，RBA流程的第1阶段和第2阶段分别为68个和73个日历日。还分析了端到端注册流程各个阶段的中位数，以便提高流程效率。
该研究的观察结果确定了RBA流程，该流程可用于缩短监管评估时间，同时确保及时批准安全、有效、质量合格的药品。对一个流程进行持续监测仍然是确保注册流程有效性所需的关键工具之一。由于其缺点，RBA流程对于不符合依赖方法条件的仿制药申请来说也是一个更好的选择。因此，这个稳健的程序可供其他可能有积压或希望优化其注册流程的监管机构使用。
