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

Abstract

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.

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

“…Keyter et al studied the review times for NASs for South Africa in comparison with NRAs in Australia, Canada, Singapore, and Switzerland and found that the South African overall review timelines were substantially longer [13]. The median approval time for NASs achieved from 2008-2017 by the NRAs in Australia, Canada, Europe, Japan, Switzerland, and the United States were approximately four times faster than that achieved by South Africa under the former MCC [11].…”

“…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].…”

An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology

“…The outcome of participation is the receipt of factual results that can be used to help better convey their mission and needs to policy-makers and other stakeholders as well as to continuously monitor their performance for purposes of improvement of timelines and quality of processes. The results generated by OpERA have been used by agencies to compare their activities against those of similar agencies and to provide the basis for a public discussion of new legislative approaches to the optimization of regulatory procedures [12][13][14].…”

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

“…Given the vast workload faced by the EAC MRH initiative, as well as by other regulatory programs across the world, collaborating with peer institutions has become a necessity. Could the initiative deliver a greater public health benefit if it started relying more on existing product assessments carried out by trusted regulatory authorities, as urged by the World Health Organization (WHO) [19] and practiced by other regulatory authorities [20,21] (Box 1)? This could free up the EAC MRH initiative's time and resources to focus on which aspects of the assessments done by other agencies are relevant to EAC countries, as well as on carrying out more good manufacturing practice inspections and pharmacovigilance activities.…”

“…In practice, reliance can take many forms, such as establishing a recognition protocol by which the decisions of trusted regulatory authorities (such as WHO's Prequalification Programme, the US FDA, or the EU's medicines assessment and licensing system) are routinely accepted or developing an abridged review process for products already approved by those institutions [20,21].…”