SAHPRA is an entity of the National Department of Health, created by the South African Government to ensure that the health and well-being of human and animal health is at its core1.
The historical trajectory:
SAHPRA assumed the roles of both the Medicines Control Council (MCC) as well as the Directorate of Radiation Control (DRC) which were housed at the National Department of Health (NDoH). Subsequently, SAHPRA was constituted as an independent entity that reports to the National Minister of Health through its Board.
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).
SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of South Africans:
It is these three pillars that define the ethos of SAHPRA.
An agile and responsive African health products regulator that is globally recognised as an enabler of access to safe, effective and quality health products in South Africa.
To promote access to health products and protect human and animal health in South Africa through making science-based regulatory decisions.
2.1.1. SAHPRA Mandate Obligations and Functions
The South African Health Products Authority (SAHPRA) is the Regulatory Authority of South Africa, which is responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nucleides; and the conduct of clinical trials.
The legislative mandates of SAHPRA are derived from the Constitution; the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (herein after referred to as “the Medicines Act”); and other relevant legislation, regulations and policies.
Further, SAHPRA’s mandate has expanded to include the regulation and control of radiation emitting devices and radioactive nucleides under the Medicines Act and the Hazardous Substances Act, 1973 (Act No. 15 of 1973).
2.1.2. The Constitution of the Republic of South Africa, 1996
In terms of the Constitutional provisions, the Authority is, amongst others, guided by the following sections and schedules: The Constitution of the Republic of South Africa, 1996, places obligations on the state to progressively realize socio-economic rights, including access to health care. Section 27 of Chapter 2 of the Bill of Rights of the Constitution states the following with regard to healthcare, food, water and social security:
2.1.3. The National Health Act, 2003 (Act No. 61 of 2003)
2.1.4. The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as amended
The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), which was amended by Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015) and enacted in May 2017, enabled, amongst others, the establishment of SAHPRA, the licensing of manufacturers and importers of Active Pharmaceutical Ingredients, and the regulation of medical devices.
In terms of the Medicines Act, the objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, medical devices, radiation control, clinical trials and related matters in the public interest. It also provides for registration and control of veterinary medicines in such a way as to ensure that they are produced, distributed and used without compromising human and animal
health. Antimicrobials intended for use in animals and registered under the Medicines Act can only be administered or prescribed by a veterinarian.
As per section 2B (1) of the Medicines Act, the Authority must, in order to achieve its objects:
In executing its functions, the Authority may:
2.1.5. Hazardous Substances Act (Act No. 15 of 1973)
Within the Medicines Act, “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973) (herein after referred to as “the Hazardous Substances Act”). The Hazardous Substances Act provides for the efficient, effective and ethical evaluation and registration of non-ionizing radiation emitting devices and radioactive nucleides. It also prohibits and controls the importation, manufacture, sale, use, operation, application, modification, disposal or dumping of substances and (electronic) products that may cause injury or death due to their detrimental direct or indirect effects. The Hazardous Substances Act classifies such substances and products in groups according to the risk associated with them. Group I, Group II, Group Ill or Group IV hazardous substance means a substance, mixture of substances, product or material declared in terms of section 2 (1) of the Hazardous Substances Act to be a Group I, Group II, Group III or Group IV hazardous substance, respectively;