Transitioning regulatory authorities in South Africa: a comparative review of the organisational structure and management practices.

Abstract

Background: South Africa's transition from the Medicines Control Council (MCC) to the South African Health Products Regulatory Authority (SAHPRA) in 2018 marked a critical shift in the regulatory landscape. The MCC faced prolonged timelines, inadequate resources and a growing application backlog. This review comparatively examines how organisational, governance, managerial and procedural reforms introduced under SAHPRA (2018-2022) addressed these structural and performance limitations, and assesses their implications for regulatory policy and future system strengthening.

Method: A mixed-method literature review combining qualitative thematic synthesis and quantitative descriptive analysis was conducted, drawing on publicly available sources, including government reports, academic journal articles, and organisational websites. Quantitative data (e.g. median approval timelines, backlog volumes and approval numbers) were systematically extracted from included studies and official reports without primary statistical modelling. Keywords included 'SAHPRA', 'MCC', 'management structures', 'organisational structures', 'regulatory review process', 'approval timelines', 'medicine approval', and 'regulatory authorities'. Screening followed predefined inclusion and exclusion criteria, and data extraction captured governance structures, funding models, quality systems, reliance pathways, review timelines and backlog metrics.

Results: SAHPRA's implementation of reliance-based review pathways and risk-based assessments, alongside streamlined operations, reduced median approval times from 2,124 in 2018 to 783 days in 2020, and increased new chemical entity registrations from 15 to 155 over the same period. The inherited backlog (8,220 new applications in 2018) was cleared by 2022. The transition improved financial independence, enhanced institutional autonomy and reduced administrative bottlenecks. SAHPRA also demonstrated responsiveness during the COVID-19 pandemic through expedited review pathways.

Conclusion: The transition from MCC to SAHPRA represents a structural and procedural modernisation of South Africa's regulatory framework. While improving efficiency and access to essential medicines, findings should be interpreted cautiously due to reliance on secondary data and variation across sources. Continued digital reform, capacity development and strengthening post-marketing surveillance remain key priorities.