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

Abstract

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.

Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities

“…This process has proven effective, as the median approval time for NCEs was the lowest of all the product types registered in Zimbabwe, ranging from 239 to 306 calendar days (8-10 months) over the study period, and this has not resulted in any increase in the incidence reports of post-marketing adverse events. The review times for NCEs are comparable to the time taken by mature agencies and much lower than the 3-6 years reported for review of new active substances in other countries in the region who conduct a full review [19,20]. The results of this study show that all products are placed in the same queue for review regardless of the type of review to be conducted.…”

“…Unlike high-income countries, there is limited information in the public domain on the regulatory review/assessment systems and performance of LMIC [15]. Evaluation of the regulatory review systems of a number of high-income and upper middle-income countries, for example, Saudi Arabia, Jordan, Turkey, and South Africa, are available in the literature [16][17][18][19][20]. However, it appears that there are few published assessments of the regulatory review systems in LMIC in Africa.…”

A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency

“…As a result, recommendations for an improved model for the regulatory review of medicines have been proposed. These studies 7,8,10,[17][18][19] have been valuable in providing a baseline against which the results of the recommended improvements to the reformed regulatory review process under SAHPRA may be quantitatively evaluated and presented. Following the implementation of the SAHPRA re-engineered processes it would be useful to reflect on its revised organisational structure, regulatory review process and regulatory performance; evaluate its performance metrics and overall median approval times for NASs (2019-2020) and compare its new registration process and regulatory review model against other similar-sized NRAs.…”

“…The increasing volume of applications received by the MCC, coupled with resource constraints, resulted in the development of a significant backlog in medicine registration and an unprecedented extension of their respective review timelines. 7,8 The approval timelines for new active substances (NASs) in South Africa were much longer than those achieved by NRAs in developed and comparable emerging economies. 9 The MCC regulatory review process was deemed to be inherently slow as a result of insufficient human and financial resources, outdated manual document management systems Implications for policy makers • The studies described here have resulted in recommendations for an improved model for the regulatory review of medicines by the South African Health Products Regulatory Authority (SAHPRA) and provided a baseline against which future improvements implemented by SAHPRA may be measured.…”

“…Regulatory Framework of SAHPRA The results have identified inefficiencies in the regulatory framework of SAHPRA and the opportunities for improvement in its regulatory performance. 7,8,10,[17][18][19] These include: quality measures; monitoring and evaluating review times; a risk-based approach to the evaluation of medicines; transparency and communication; and training and education (Figure 2).…”