The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland

© 2019 Keyter, Salek, Banoo and Walker.Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study were to compare the registration process and the regulatory review model of the South African Medicines Control Council (MCC) to that of four other similar-sized regulatory authorities and to identify areas for improvement that may inform recommendations to the South African Health Products Regulatory Authority (SAHPRA) as it looks to re-engineer and enhance the registration process in South Africa. Methods: A questionnaire describing the organisational structure, the registration process, good review and decision-making practices of the MCC was completed by the author (AK) for the purpose of this study and validated by the Registrar of the MCC. Similar questionnaires were also completed and validated by Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, Singapore’s Health Science Authority (HSA) and Switzerland’s Swissmedic. Results: A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and employ a full-review model although the timelines for the MCC were considerably longer. However, similar quality measures were implemented by all authorities as part of their good review practices (GRevP) including prioritising transparency, communication, continuous improvement initiatives and training. Conclusion: Comparisons made through this study provided insight into the areas of the MCC registration process that may be improved and have informed recommendations to SAHPRA including the implementation of facilitated regulatory pathways, definition of targets for key milestones in regulatory review and formal implementation and monitoring of GRevP. In order to build quality into the review process the application of a standardised template for the clinical assessment of medicines such as the Universal Methodology for Benefit-Risk Assessment (UMBRA) could be considered as well as enhancing transparency and communication through the application of an electronic management system and the development of publicly available summaries for the basis of approval.Peer reviewedFinal Published versio

An Evaluation of the Regulatory Environment in South Africa: Improving the Review Process and Patients' Access to Medicines

National regulatory authorities (NRAs) are responsible for the evaluation of medicines and for ensuring that only those products which meet the requirements of quality, safety and efficacy are registered and made available to patients. The NRAs are required to effect such regulatory mandates efficiently and ensure timely patients’ access to medicines. Many NRAs, especially in resource-limited settings or emerging markets face challenges in fulfilling these mandates as resources are stretched to capacity. Adopting a risk-based approach to medicine evaluation can provide relief for NRAs striving towards improved regulatory performance. The NRAs may implement facilitated regulatory pathways, appropriate frameworks for benefit-risk (BR) assessment and abridged review processes in order to leverage reliance mechanisms and good regulatory practices to improve regulatory efficiencies. The aim of this research was to evaluate the regulatory environment in South Africa with a view to improve the review process for medicines and to ensure their timely access by patients. This was achieved through a review of the legislative framework and historical context supporting the new regulatory environment in South Africa and the transition from the Medicines Control Council (MCC) to South African Health Products Regulatory Authority (SAHPRA). The regulatory performance of the South African regulatory authority and how it compared to that of other agencies was evaluated and the strategies supporting enhanced BR assessment and reliance mechanisms were appraised. Various methodologies were considered in determining an appropriate study design and a mixed method approach, including a combination of self-administered questionnaires, focus groups and a case study, was adopted to support achieving the study objectives. A questionnaire was used to evaluate the review process of the MCC and the results demonstrated that the MCC was not able to meet target timelines for the review of new active substances (NASs). A comparison was made between the MCC and other similar NRAs using the same questionnaire. The results indicated that the MCC had similar requirements to other agencies and all the NRAs conducted a full assessment of applications for the registration of NASs. However, the approval times for the MCC were considerably longer. Further investigation into these lengthy timelines resulted in the analysis of the performance metrics of the MCC between 2015-2017 and of SAHPRA in 2018. A case study approach and focus group were used to evaluate strategies for enhanced communication of BR assessments and a questionnaire and two focus groups were conducted to understand the implications of the application of an abridged review in the evaluation of NASs. The results of these studies culminated in the development of a proposed improved model for the regulatory review process of new active substance (NASs) for SAHPRA. This programme of research has presented, in a seminal piece of work, key recommendations for the improvement of the regulatory review process as it may be applied by SAHPRA. The results from this work provide, for the first time, a baseline against which future improvements, implemented by SAHPRA, may be measured. The implementation of these recommendations will contribute towards an enhanced regulatory performance, underpinned by good regulatory, good review and good reliance practices. This will result in a stream-lined review process, improved regulatory responsiveness, consistency, transparency and accountability and ultimately patients’ timely access to medicines.

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices that have been implemented by SAHPRA to support the assessment of new chemical entities and generic product applications for market authorization in the business-as-usual and backlog process streams. Methods: A questionnaire was completed and verified by SAHPRA to describe the structure of the organization, the resources available, the process for regulatory review of new chemical entities and generic products and the level of implementation of good review practices and regulatory decision-making practices for market authorization. Data were collected and analyzed on the overall approval timelines for new chemical entities and generic products registered by SAHPRA in 2020 in the business-as-usual and backlog process streams. Results: A full, independent scientific review was conducted for all new chemical entities and generic product applications in the business-as-usual stream. Facilitated regulatory pathways were introduced for the review of new chemical entities and generic products in the backlog stream. As a result, the timelines for approval of applications in the backlog stream were 68% quicker for both new chemical entities and generics, using facilitated regulatory pathways, such as abridged and verification review models. Conclusion: The comparisons made through this study provided insight into the improvements that have been made through the establishment of SAHPRA and the transition in 2018 from the MCC. The re-engineered processes that have been developed and implemented by SAHPRA to address the backlog in the review of the applications for market authorization have demonstrated a decrease in the overall median approval times. The expansion of these processes into the routine review of medical products will contribute to the enhanced regulatory performance of SAHPRA and patients’ access to new medicines.Peer reviewe