The South African Regulatory System: Past, Present, and Future

Abstract

The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date failed and resources have been stretched to capacity resulting in the development of a significant backlog and extended timelines for product registration. The promulgation of the recently amended Medicines and Related Substance Act of 1965 triggered the establishment of the South African Health Products Regulatory Authority (SAHPRA) as a separate juristic person outside of the National Department of Health to replace the former medicine regulatory authority the Medicines Control Council (MCC). The aim of this review is to provide the historical context supporting the new regulatory environment in South Africa and the transition from the MCC to SAHPRA. Key recommendations to SAHPRA to ensure the full potential of the new regulatory environment in South Africa include: establishing a quality management system to safeguard accountability, consistency and transparency and to streamline the implementation of good review practices including quality decision-making practices and benefit-risk assessment; the measurement and monitoring of regulatory performance, targets for overall approval time and key review milestones to instill a culture of accurate metrics collection and measurement of key performance indicators and their continuous improvement and the employment of a risk-based approach to the evaluation of medical products and codify the use of facilitated regulatory pathways in policy and culture. The application of a risk-based approach to regulatory review commensurate with a product’s risk to patients will facilitate the application of increased resources for pharmacovigilance activities and to support the reliance and recognition of reference agencies.

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

“…As such, it is critical to any improvement to ensure the routine and accurate measurement and monitoring of performance metrics of the regulatory review process. Benchmarking milestones currently used by NRAs typically include the times for receipt and validation, scientific assessment, applicants' response, and market authorization to be granted as well as the time taken to complete all administrative activities [9]. The data collected from the MCC and SAHPRA for the period 2015-2018 demonstrated that several of these milestones were recorded, but not measured and monitored.…”

“…The overall approval timelines for the regulatory review achieved by the MCC (2015-2017) and by SAHPRA (2018) are extensive and do not contribute to ensuring timely access to medicines for patients in South Africa. Keyter et al previously described both the historical and operational factors that have contributed to these extended timelines [9]. While there are currently no comparative studies available to reflect the regulatory performance of South Africa relative to other African countries, it has been noted that a target overall approval timeline of 330 calendar days has been set by the Zazibona collaborative process [10], a harmonization and joint-review initiative in the Southern African Development Community (SADC) region, in which South Africa has participated since 2016.…”

“…This stratified approach may also require SAHPRA to consider regulatory trade-offs involving acceptance of surrogate end-points supported by strengthened post-marketing commitments such as the reallocation of regulatory resources from pre-marketing to post-marketing functions [5,17]. As SAHPRA moves forward with the implementation of the newly restructured review process, it is critical to ensure that the quality management system is formalized to support the consistent application of good regulatory, review, and reliance practices within the review process [6,9,13]. Furthermore, in an effort to prove itself as an effective, responsive, transparent, and accountable regulatory authority, SAHPRA should consider the use of the universal methodology for benefit-risk assessment of NASs and progressive quality decision-making practices [6,9,13,18,19].…”

Unintended Consequences and Hidden Obstacles in Medicine Access in Sub-Saharan Africa

“…Poor hiring policies limit performance; for example, NRAs commonly hire pharmacists in roles requiring different competencies than what they were trained for. NRAs disproportionally allocate resources on upstream functions (Figure 1) that can be simplified or de-duplicated through regulatory harmonization (36). Finite NRA resources should instead be spent on downstream functions such as post-market surveillance and detection of illegitimate drugs.…”

Medicine Knowledge and Purchasing Behaviour in a South African Township: Lessons Learnt From a Pilot Study on Awareness of Substandard and Falsified Medical Products

“…South Africa also has the strongest pharmaceutical sector amongst sub-Saharan African countries (15). A recent change in the pharmaceutical regulatory authority, from the Medicines Control Council to the South African Health Products Regulatory Authority, created backlogs and uncertainty while the new regulatory agency was in the set-up phase (16). This combination of high medical expenditure and potentially still weak pharmaceutical regulatory capacity given the transition to a new regulatory authority provides the potential for SF products to spread.…”