The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System

Abstract

Background:The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices.Methods:A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs).Results:Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future.Conclusions:As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

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

“…The use of facilitated regulatory pathways is supported through Section 2B(2b) of the Medicines and Related Substance Act, 1965 (Act 101 of 1965) and should be considered in order to ensure the effective allocation of limited resources [8,15]. Participation in joint and shared review initiatives will continue to support the effort to decrease the overall approval time for medicine registration [6,16]. While the former MCC had set a target review time of 250 calendar days for products reviewed using the fast track review process, this target was not achieved during the period 2015-2017.…”

“…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].…”

“…Roth and associates have suggested that the lack of timely access to new medicines may be addressed through the strengthening of registration efficiencies and timelines by establishing and refining value-added registration processes, resources, and systems [ 5 ]. 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 ]. While this study provided an indication of the overall timelines for new active substances (NASs) approved and registered by the MCC during 2015–2017, it focused on 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 ].…”

Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

“…The review of the quality, efficacy, and safety of medicines is considered to be one of the key functions of NRAs [4] and the timely review of applications for registration of new active substances (NASs) can significantly improve patients' access to medicines and consequently impact public health [1]. The implementation of good review practices (GRevP) supports improved regulatory performance and contributes to the advancement of convergence of NRA regulatory requirements [5,6].This coupled with the alignment of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) technical guidelines would create opportunities for reliance based on the regulatory decisions of other NRAs and supports possibilities for work sharing and joint regulatory initiatives [7].…”

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

“…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 median approval times for fast track applications approved by the MCC in 2015, 2016, and 2017 were 1218, 921, and 609 calendar days, respectively (Keyter et al, 2018). There was no target time set for the overall review time of NCEs and the median approval times for NCE marketing authorization applications approved in 2015, 2016, and 2017 were 1161, 1678, and 1422 calendar days, respectively (Keyter et al, 2018).…”