South Africa’s healthcare system faces a critical challenge that often goes unseen by the public but has a profound impact on access to essential medicines—regulatory delay. While the divide between public and private sectors sets the stage for unequal access, the inability to bring medicines to market swiftly and efficiently compounds the problem, creating a bottleneck that restricts innovation, stalls affordability, and limits timely treatment availability.
In this article, we examine the root causes of regulatory inefficiencies in South Africa’s pharmaceutical system, the ongoing reform efforts led by SAHPRA, and how improving regulatory performance can be a transformative lever in ensuring health equity.
A Legacy of Delay
Before the formation of the South African Health Products Regulatory Authority (SAHPRA) in 2018, the Medicines Control Council (MCC) was widely criticised for its slow, paper-based processes and lack of operational capacity. The MCC’s inefficiencies resulted in a massive backlog, with some medicine registration applications taking up to five years to be processed [1]. These delays discouraged market entry by pharmaceutical companies and limited the availability of cost-effective generic alternatives.
SAHPRA was established to modernise regulatory processes, clear inherited backlogs, and align South Africa with international regulatory best practices. SAHPRA inherited a backlog of approximately 16,000 medicine-related applications when it took over from the Medicines Control Council in early 2018. This backlog comprised over 8,000 new medicine registrations and an almost equal number of variation applications for registered products, both generic and branded, submitted over several years. Despite the historic volume, generics represented over 90% of new registration applications in the backlog, highlighting their significant role in delayed market access [2]. While efforts such as the Backlog Clearance Project have significantly reduced these numbers, structural challenges continue to slow new product registrations.
The Impact on Access and Affordability
Regulatory delays have a downstream effect on medicine accessibility across both the public and private sectors. While generic products account for the majority of prescriptions in South Africa, originator medicines still represent a larger share of the pharmaceutical market by value due to higher unit prices. Regulatory delays affect both originator and generic (including biosimilar) products; however, prolonged approval timelines can limit timely access to lower-cost alternatives and delay competitive pricing dynamics that benefit the healthcare system.
Additionally, new global health technologies, such as improved formulations for HIV or long-acting injectable antiretrovirals, can be delayed for months or years in reaching South African patients, even when they are already approved by stringent regulatory authorities like the U.S. FDA or European Medicines Agency (EMA).
This lag is particularly problematic in a country that bears a high burden of disease and relies heavily on access to WHO-prequalified treatments. The delay not only impacts procurement timelines in the public sector but also delays access in private markets, where patients may be willing to pay but cannot find registered products.
Barriers Beyond the Backlog
While the backlog crisis brought much-needed attention to SAHPRA’s resourcing and process limitations, broader market entry barriers continue to pose significant challenges within South Africa’s pharmaceutical regulatory environment.
One major constraint lies in SAHPRA’s limited human and technological capacity, which affects its ability to process applications efficiently and respond to both global innovation and growing local demand. Administrative inefficiencies further compound delays; processes such as dossier handling, inspection scheduling, and applicant communication still rely on manual systems, contributing to avoidable lag times. The complexity of submission requirements also places strain on applicants, particularly smaller or local manufacturers.
While these requirements, including adherence to Good Manufacturing Practice (GMP), bioequivalence studies, and comprehensive documentation, are vital for ensuring quality and safety, they can act as a barrier to entry for those with limited resources. In addition, SAHPRA’s progress toward implementing reliance pathways, whereby approvals from trusted international regulatory bodies could be used to fast-track local registration, has been slower than anticipated. Although the commitment to this approach has been signalled, full operationalisation remains limited, reducing the opportunity to expedite access to medicines that have already been rigorously assessed elsewhere.
Reform Pathways and Strategic Opportunities
Reforming regulatory performance is more than an operational fix—it is a strategic imperative. Several pathways hold promise for unlocking faster access to medicines:
- Scaled reliance models: Expanding reliance on decisions by WHO, EMA, and other SRAs (Stringent Regulatory Authorities) can significantly reduce approval timelines without compromising safety or quality.
- Digital infrastructure investment: Modernising regulatory submissions and tracking systems can streamline workflows, increase transparency, and enable real-time applicant communication.
- Risk-based approaches: Differentiated review timelines based on medicine classification, such as prioritising life-saving generics over new chemical entities, can enhance the efficiency and focus of the regulatory process.
- Capacity development: Investing in regulatory workforce training, collaborative partnerships, and cross-agency knowledge sharing will enhance review quality and efficiency.
Conclusion: Regulatory Reform as a Health Equity Lever
Delays in medicine registration are not just technical or bureaucratic problems; they are a central obstacle to equitable healthcare. South Africa’s efforts to expand access, reduce costs, and localise pharmaceutical production depend on a regulatory system that is agile, transparent, and fit for purpose.
As SAHPRA continues its transformation journey, the healthcare community must advocate for sustained investment and reform. Improving regulatory efficiency is one of the most immediate and impactful ways to ensure that all South Africans, regardless of income or geography, have timely access to the medicines they need.
References
- Gray, A., & Riddin, J. (2018). The Regulatory System for Medicines in South Africa: Transition to a New Era. Journal of Pharmaceutical Policy and Practice.
- SAHPRA Annual Performance Plan (2021/2022). Backlog Clearance Progress Update.