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

https://ijhpm.com Int J Health Policy Manag 2022, 11(6), 795–809 doi 10.34172/ijhpm.2020.213 Original Article A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency ID ID Andrea Keyter1,2 , Sam Salek1* , Shabir Banoo2,3, Stuart Walker4,1 Abstract Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new regulatory review model for improved regulatory performance, underpinned by the parameters of the World Health Organization Global Benchmarking Tool (WHO GBT) that support strengthening of regulatory systems. Methods: A new enhanced model for regulatory review, was developed based on the key recommendations from 6 studies, previously conducted by the authors, that were identified as fundamental elements in enhancing regulatory performance. The elements selected to define the new regulatory review model were endorsed through the integration of the parameters of the WHO GBT that, when embedded within regulatory systems, support enhanced regulatory performance. Results: Opportunities for improvement in regulatory performance were identified and include quality measures; monitoring and evaluating review times; a risk-based evaluation; transparency and communication; and training and education. An improved model for the South African regulatory review and benefit-risk (BR) assessment supported by quality decision-making was proposed as well as recommendations for the application of risk-stratification strategies, strengthening of reliance networks, reinforcing good regulatory practices (GRPs) and enhancing transparency. Conclusion: If implemented the proposed improved regulatory model may pave the way towards more efficient and transparent, streamlined review processes, coupled with increased consistency, evidence-based decision-making practices, reduced timelines and improved patients’ access to new medicines in South Africa. Keywords: South Africa, Review Model, ZAPAR, SAHPRA, Global Benchmarking Tool Copyright: © 2022 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/ by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Citation: Keyter A, Salek S, Banoo S, Walker S. A proposed regulatory review model to support the South African Health Products Regulatory Authority to become a more efficient and effective agency. Int J Health Policy Manag. 2022;11(6):795–809.  doi:10.34172/ijhpm.2020.213 Background The effective regulation of medicines, the strengthening of regulatory systems and the improvement of regulatory performance have become the focus for national regulatory authorities (NRAs) and governments worldwide. The NRAs are responsible for protecting and promoting public health, implementing rigorous regulatory standards and maintaining an assured supply of medicines which are safe, effective and of good quality.1-3 However, global mounting pressure on NRAs of all sizes and capacities have been noted due to the larger volumes of marketing authorisation applications received, the complexity of the submissions and the increased categories of medicines.4 Whilst patient-focused, evidence-based, risk-oriented, transparent, effective and flexible practices are the mainstay of medicines regulation,5 for many NRAs, particularly in emerging economies with resource-limited settings, achieving these types of practices has not been a reality.6 In response to these challenges, NRAs of various sizes Full list of authors’ affiliations is available at the end of the article. Article History: Received: 22 April 2020 Accepted: 21 October 2020 ePublished: 23 November 2020 *Correspondence to: Sam Salek Email: and maturity levels have had to revise legacy systems and reengineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. Regulatory Challenges in South Africa The Medicines Control Council (MCC), the past NRA in South Africa, had historically faced similar difficulties. 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 Keyter et al Key Messages 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. • Following the implementation of the SAHPRA re-engineered processes it would be useful to compare the new registration process and regulatory review model of SAHPRA against other similar-sized national regulatory agencies. • Provided that the recommendation to identify and routinely monitor and evaluate the milestones in the regulatory review process is implemented, it would be useful to analyse the timelines achieved between these milestones in order to accurately determine the time taken by SAHPRA to review an application and the time taken by the applicant to provide the required response/s to SAHPRA. • Considering the intention of SAHPRA to implement facilitated regulatory pathways (FRPs), it would be valuable to study the overall median approval timelines achieved for full, abridged and verification reviews and their impact on patients’ access to medicines. • The use of a structured universal template for benefit-risk (BR) assessment both for SAHPRA and for regional initiatives has been encouraged. This would support predictable, transparent and quality decision-making and provide an effective approach for communicating BR decisions made through the use of collaborative initiatives and could form the basis of a public assessment report (PAR). Implications for the public The increasing volume of applications received by the former national regulatory agency in South Africa, coupled with resource constraints, outdated manual document management systems and legislative constraints, resulted in the development of a signif (...truncated)