ANNUAL REPORT
2024
I am pleased to present the 2023-24 Annual Report for SAHPRA which is mandated by the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to regulate all health products and their use in South Africa. Like the rest of the world, South Africa is still recovering from the COVID-19 pandemic and is struggling with a weakened economy and political uncertainty. This has impacted SAHPRA both financially and in terms of staff morale. Despite this, SAHPRA has delivered on its mandate to ensure that health products for human and veterinary use are safe, efficacious and of good quality. SAHPRA’s portfolio of responsibilities is many and varied. Throughout COVID-19 pandemic, SAHPRA played a critical role in facilitating the emergency licensure of health products and is currently supporting the Department of Health’s emergency response to the current Mpox outbreak, ensuring access to critical therapeutics and vaccines. SAHPRA also managed to work on new horizons such as cannabis licensure, digitisation and regional harmonisation initiatives. Further objective demonstrations of SAHPRA’s growing effectiveness include an unqualified audit (2022/23), a reduction of irregular, fruitless and wasteful expenditure and a revised structure for service fees, which is in progress.
During the 2023/24 financial year, SAHPRA had six outcomes addressing Priority 3 of the country’s Medium-Term Strategic Framework, “Education Skills and Health”, which are:
Reduced funding from National Treasury for the 2023/24 financial year, put SAHPRA under enormous financial constraints.
To address this, cost containment measures were introduced, including a reduction in operational costs and new staff hires, as well as an increase in revenue collection. Despite the challenging environment, SAHPRA achieved 68% of its annual targets while spending 100% of its reduced budget allocation, complemented by significant third-stream funding earmarked for specific projects.
The Board, which is in its second term, has had a major focus on good governance and ensuring that SAHPRA’s strategic plan is fit for the purpose of achieving the regulator’s ambitions. This ambition has been supported by the Minister of Health, Dr Joe Phaahla, who has appointed the responsible DDG to sit on the SAHPRA Board.
The post-COVID period has increased the global understanding of the importance of developing competent regulatory authorities in low- and middle-income countries, especially in the African region. SAHPRA is regarded as a leading African regulator, and it works closely with other African and global regulators, the newly emerging African Medicines Agency, and the World Health Organisation (WHO).