Who is SAHPRA (South African Health Products Regulatory Authority) June 2025.
SAHPRA is the South African Health Products Regulatory Authority.
The South African government established it as a Section 3A public institution to supervise the regulation of health goods such as medications, medical equipment, in-vitro diagnostic tests and devices, and radiation emitting items and devices used in health care and industry.
The Medicines Control Council (MCC) and the Directorate of Radiation Control have been replaced by SAHPRA (DRC).
SAHPRA Management and Board
SAHPRA is governed by a Board of Directors chosen by the Minister of Health.
The Board appoints the Chief Executive Officer (CEO) after consulting with the Minister of Health.
Several top management roles, including Chief Financial Officer, Director of Information Technology, and Company Secretary, have been filled.
Others, such as the Chief Regulatory Officer and top managers in each division, are being filled for the first time.
What does SAHPRA do?
The Medicines and Related Substances Act of 1965 requires SAHPRA to regulate all health goods in South Africa and their usage.
The duty of supervising radiation control in South Africa has also been transferred to SAHPRA.
The Hazardous Substances Act governs this role, which is designed to safeguard the public from radiation used in both medical and industrial contexts.
SAHPRA’s job is to protect and promote public health by ensuring that all medications and medical devices accessible and utilized in the nation are safe, effective, and of high quality.
All functions are active now, although some are new, such as medical device registration and vigilance, as well as oversight of clinical trials for medical devices and in-vitro diagnostics, and the entire spectrum of operations will only be implemented over the next few years.
SAHPRA services in a nutshell.
- Medicines
- Complementary Medicines
- Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)
- Radiation Controlare safe, effective and of good quality and in the interest of the public throughout their life cycle.
How is SAHPRA Funded?
Through the National Department of Health budget, SAHPRA receives a portion of its funding from the national treasury.
The rest of SAHPRA’s funding comes from fees for services performed in the execution of its mandates.
The entity may also accept donations if the National Treasury Regulations are followed.
The majority of SAHPRA’s funds are projected to come from fees over time.
The goal is to provide better, quicker services and therefore justify higher rates.
Several functions are now given for free, however this will change in the future.
Backlogs
SAHPRA has pledged to resolving a backlog of medication applications, which includes both pre-registration and post-registration amendment applications, within two years.
The backlog clearance strategy comprises three pillars:
- reducing the number of applications that require evaluation.
- segmenting and prioritising applications on the basis of public health need, and
- implementing new models for evaluation that recognise work done by other national regulatory agencies.
SAHPRA’s Operational Model
The initial members of SAHPRA came from several divisions under the National Department of Health.
SAHPRA has acquired temporary office space at the CSIR Pretoria Campus.
Plans are in the works to ensure a long-term solution.
- Programme 1 Corporate Services.
- Programme 2 Health Product Authorisation.
- Programme 3 Inspectorate and Regulatory Compliance.
- Programme 4 Evaluation for Registration.
- Programme 5 Medical Devices and Radiation Control.
For more information on SAHPRA, please visit their website on the following link www.sahpra.org.za
