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

Document Type : Original Article

Authors

1 Department of Clinical and Pharmaceutical Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK

2 South African Health Products Regulatory Authority, Pretoria, South Africa

3 Faculty of Health Sciences, University of the Witwatersrand, Witwatersrand, South Africa

4 Centre for Innovation in Regulatory Science, London, UK

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


  1. Rägo L, Santoso B. Drug regulation: history, present and future. In: van Boxtel CJ, Santoso B, Edwards IR, eds. Drug Benefits and Risks: International Textbook of Clinical Pharmacology. 2nd ed. Amsterdam: IOS Press and Uppsala Monitoring Centre; 2008.
  2. Ndomondo-Sigonda M, Miot J, Naidoo S, Dodoo A, Kaale E. Medicines regulation in Africa: current state and opportunities. Pharmaceut Med. 2017;31(6):383-397. doi:10.1007/s40290-017-0210-x
  3. World Health Organization (WHO). Improving the Quality of Medical Products for Universal Access. WHO; 2018. http://www.who.int/medicines/regulation/fact-figures-qual-med/en/.  Accessed March 30, 2018.
  4. World Health Organization (WHO). Good Review Practices: Guidelines for National and Regional Regulatory Authorities. WHO Technical Report Series. 2015;992 (Annex 9):91-210. http://apps.who.int/medicinedocs/en/d/Js21902en/.  Accessed May 7, 2018.
  5. Azatyan S. Overview on Medicines Regulation: Regulatory Cooperation and Harmonization in the Focus. Presented at: Forecasting global ARV demand 2010-2012 and improving access to adult and pediatric treatment. Geneva, Switzerland: WHO; 2009. https://www.who.int/hiv/amds/who_overview_medicines_regulation_azatyan.pdf.  Accessed January 27, 2020.
  6. World Health Organization (WHO). Regulatory System Strengthening for Medical Products. WHO; 2014. (EB134.R17). http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_R17-en.pdf.  Accessed May 14, 2018. Published 2014.
  7. Keyter A, Gouws J, Salek S, Walker S. The regulatory review process in South Africa: challenges and opportunities for a new improved system. Ther Innov Regul Sci. 2018;52(4):449-458. doi:10.1177/2168479018776649
  8. Keyter A, Salek S, Gouws J, Banoo S, Walker S. Evaluation of the performance of the South Africa regulatory agency: recommendations for improved patients' access to medicines. Ther Innov Regul Sci. 2020;54(4):878-887. doi:10.1007/s43441-019-00013-5
  9. Centre for Innovation in Regulatory Science (CIRS). Emerging Markets Approval Timelines. London: CIRS; 2019.
  10. Keyter A, Banoo S, Salek S, Walker S. The South African regulatory system: past, present, and future. Front Pharmacol. 2018;9:1407. doi:10.3389/fphar.2018.01407
  11. Ward M. Regulatory harmonization: the international generic drug regulators pilot. WHO Drug Inf. 2014:28(1):3-10.
  12. Ward M. Risk-Based Approaches to the Evaluation of New Medicines: What does this Mean and Why Should Countries Consider Such an Approach? Sao Paulo, Brazil: Centre for Innovation in Regulatory Science (CIRS); 2017.
  13. World Health Assembly (WHA). Resolution WHA67.20. Regulatory System Strengthening for Medical Products. http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf.  Accessed March 31, 2018.
  14. World Health Organization (WHO). WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory Systems. WHO; 2020.
  15. Centre for Innovation in Regulatory Science (CIRS). Facilitating the Review of New Medicines through Risk-Based Evaluations: How Can a Stratification Process be Utilised to Achieve an Effective use of Resources? London: CIRS; 2017.
  16. 16. Rodier C, Patel P, McAuslane N, Liberti L. The OpERA Programme: Measuring Process and Performance in Regulatory Agencies. https://www.cirsci.org/wp-content/uploads/2020/02/CIRS-RD-Briefing-74-OpERA-programme.pdf.    Published 2020.
  17. Keyter A, Salek S, Banoo S, Walker S. The South African medicines control council: comparison of its registration process with Australia, Canada, Singapore, and Switzerland. Front Pharmacol. 2019;10:228. doi:10.3389/fphar.2019.00228
  18. Keyter A, Salek S, Banoo S, Walker S. Can standardisation of the public assessment report improve benefit-risk communication? Front Pharmacol. 2020;11:855. doi:10.3389/fphar.2020.00855
  19. Keyter A, Salek S, McAuslane N, Banoo S, Azatyan S, Walker S. Implementation of a framework for an abridged review using good reliance practices: optimising the medicine regulatory review process in South Africa. Ther Innov Regul Sci. 2020;54(5):1199-1207. doi:10.1007/s43441-020-00144-0
  20. Donelan R, Walker S, Salek S. The development and validation of a generic instrument, QoDoS, for assessing the quality of decision making. Front Pharmacol. 2016;7:180. doi:10.3389/fphar.2016.00180
  21. Bujar M, McAuslane N, Walker SR, Salek S. Evaluating quality of decision-making processes in medicines' development, regulatory review, and health technology assessment: a systematic review of the literature. Front Pharmacol. 2017;8:189. doi:10.3389/fphar.2017.00189
  22. World Health Organization (WHO). Draft Working Document for Comments: Good Reliance Practices in Regulatory Decision-Making: High-Level Principles and Recommendations. WHO; 2020. https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_851_good_reliance_practices.pdf?ua=1.  Accessed August 4, 2020.
  23. World Health Organization (WHO). WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products: Registration and Marketing Authorization (MA): Indicators and Fact Sheets. Revision VI version 1. https://www.who.int/medicines/regulation/02_GBT_MA_RevVI.pdf?ua=1.  Accessed January 25, 2019. Published 2018.
  24. World Health Organization (WHO). WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products: National Regulatory System (RS): Indicators and Fact Sheets. Revision VI version 1. https://www.who.int/medicines/areas/regulation/01_GBT_RS_RevVI.pdf?ua=1.  Accessed January 25, 2019. Published 2018.
  25. World Health Organization (WHO). WHO Guideline on the Implementation of Quality Management Systems for National Regulatory Authorities. WHO; 2019. https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_783_implementation_of_qms_for_nras.pdf?ua=1.  Accessed November 13, 2019.