SAHPRA acknowledges that the “transition to more advanced digital regulatory systems could be lagging a bit, slowing the efficiency and effectiveness of operations”. But it says it hopes that over the next two years it will implement “digital systems for regulatory submissions and tracking, as well as leveraging Artificial Intelligence for more efficient assessments”
The regulator says that as health technologies evolve, it seeks to develop capacity and expertise in areas such as “ AI-driven diagnostics and novel therapeutic approaches”.
The regulator also includes in the Performance Plan that it “sees the opportunity to strengthen its role in harmonizing regulatory standards across Africa, enhancing its influence and positioning South Africa as a regional leader”.
It says there is a growing market for new treatments such as cannabis-derived products, gene therapies, and personalised medicine and that the Authority “seeks to ensure it has fit-for purpose regulatory frameworks for to regulate these emerging sector”.
Excerpt from SAHPRA’s 2025/6 Performance Plan (undated)
Medical Cannabis – SAHPRA’s Role:
Medicinal Cannabis Regulation:
SAHPRA oversees the licensing, cultivation, manufacture, and distribution of cannabis for medicinal and research purposes.
Scheduling of Cannabis:
- THC (Tetrahydrocannabinol): Classified as a Schedule 6 substance, available only via prescription.
- CBD (Cannabidiol): Generally classified as Schedule 4, though low-dose CBD products are exempted (Schedule 0).
SAHPRA ensures compliance with stringent standards like Good Manufacturing Practice (GMP) for medicinal cannabis products. Licensing is required for any commercial cultivation or production of medicinal cannabis, along with permits from the Director-General of Health.
South Africa’s recent developments in medical cannabis regulation requires the Authority to work on refining the legal framework to address issues such as patient access, safety, and product standardization.
SAHPRA has been at the forefront of regulating medicinal cannabis since the Prince II Constitutional Court judgement effected the removal of the Cannabis Plant from the Schedules to the Medicines Act and the inclusion of THC in Schedule 6, making cannabinoids available for medicinal use.
In line with the resolutions from the Cannabis Phakisa held in 2023, SAHPRA amended the schedules to better align with the evolving cannabis landscape.
This included enabling the Minister of Agriculture to determine the limit for low-THC cannabis and ensuring that all cannabis cultivation is regulated under a permit system as per the Plant Improvement Act.
These changes have allowed for the streamlining of what SAHPRA licences, and allows for the clarification of the roles of various departments regulating cannabis related products, whilst still ensuring that SAHPRA has oversight over cannabis for medicinal use.
These measures will help streamline the regulatory process and support the development of a robust and inclusive cannabis industry in South Africa, by removing barriers in the schedules that prevented industrial and other non-medical use to be regulated by other government entities.
The schedule inscription changes for THC also allows further SAHPRA plans to enhance its regulatory framework by implementing more robust and clear guidelines for monitoring to prevent the diversion of medicinal cannabis into the illicit market, enabling patient access and providing pathways to product authorisation in the pharmaceutical supply chain by licenced entities.
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