Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients\u2019 Access to Medicines

Andrea Keyter,Joey Gouws,Stuart Walker,Sam Salek,Shabir Banoo

doi:10.1007/s43441-019-00013-5

Abstract

BackgroundTimely 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.MethodsData identifying the milestones and overall approval times for NASs registered by the South African Agency during 2015–2018 were collected and analyzed.ResultsThe 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.ConclusionsWhile 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.

Highlights

National regulatory authorities (NRAs) are mandated to ensure the quality, safety, and efficacy of medicinal products [1,2,3]; the World Health Organization (WHO) has reported that one-third of the world’s population does not have timely access to such products [4]
While this study provided an indication of the overall timelines for new active substances (NASs) approved and registered by the Medicines Control Council (MCC) during 2015–2017, it focused on Therapeutic Innovation & Regulatory Science (2020) 54:878–887 the organization and the regulatory review process of the MCC and the status of good review practices that had been implemented by that organization [6]
While the data for the period 2015–2017 represent the performance of the MCC, the results described for 2018 reflect the performance of South Africa Health Products Regulatory Authority (SAHPRA) during the initial stages of its establishment and transition

Summary

Introduction

National regulatory authorities (NRAs) are mandated to ensure the quality, safety, and efficacy of medicinal products [1,2,3]; the World Health Organization (WHO) has reported that one-third of the world’s population does not have timely access to such products [4]. Keyter et al evaluated the South African regulatory review process, as it had been applied by the Medicines Control Council (MCC), prior to the establishment of the South Africa Health Products Regulatory Authority (SAHPRA) [6]. 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. 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

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