The South African Health Products Regulatory Authority (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 are at its core.
SAHPRA is a Schedule 3A public entity that is responsible for:
- the regulation of health products intended for human and animal use;
- the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices and radioactive nuclides;
- the conduct of clinical trials in a manner that is compatible with the national medicines policy.
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’s Core Business
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:
- Safety
- Efficacy
- Quality
It is these three pillars that define the ethos of SAHPRA.
Vision
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.
Mission
To promote access to health products and protect human and animal health in South Africa through making science-based regulatory decisions.
Values
- Ubuntu
- Responsiveness
- Integrity
- Transparency
- Efficiency
- Excellence
Legislative and other Mandates
2.1.1. SAHPRA Mandate Obligations and Functions
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 nuclides; 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 nuclides 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:
- Everyone has the right to have access to health care services, including reproductive health care; sufficient food and water; and social security, including, if they are unable to support themselves and their dependents, appropriate social assistance.
- The state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of each of these rights; and no one may be refused emergency medical treatment.
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2.1.3. The National Health Act, 2003 (Act No. 61 of 2003)
- Provides a framework for a structured uniform health system within the Republic, taking into account the obligations imposed by the Constitution and other laws on national, provincial and local government with regard to health services. The objectives of the National Health Act (NHA) are to:
- Unite the various elements of the national health system in a common goal to actively promote and improve the national health system in South Africa;
- Provide for a system of co-operative governance and management of health services, within national guidelines, norms and standards, in which each province, municipality and health district must address questions of health policy and delivery of quality health care services;
- Establish a health system based on decentralized management, principles of equity, efficiency, sound governance, internationally recognized standards of research and a spirit of enquiry and advocacy which encourage participation;
- Promote a spirit of co-operation and shared responsibility among public and private health professionals and providers and other relevant sectors within the context of national, provincial and district health plans;
- Create the foundations of the health care system, and
- Must be understood alongside other laws and policies that relate to health.
- Create the foundations of the health care system, and
- Must be understood alongside other laws and policies that relate to health.
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:
- Ensure the efficient, effective and ethical evaluation or assessment and regulation of medicines, medical devices, radiation emitting devices and radioactive nucleides that meet the defined standards of quality, safety, efficacy and performance, where applicable;
- Ensure that the process of evaluating or assessing and registering of medicines, medical devices, radiation emitting devices and radioactive nucleides is transparent, fair, objective and concluded timeously;
- Ensure the periodic re-evaluation or re-assessment and ongoing monitoring of medicines, medical devices, radiation emitting devices and radioactive nucleides;
- Ensure that evidence of existing and new adverse events and reactions, interactions, and signals emerging from post-marketing surveillance and vigilance activities are investigated, monitored, analysed and acted upon;
- Ensure that compliance with existing legislation is promoted and achieved through a process of active inspection and investigation; and
- Ensure that clinical trial or clinical performance study protocols are assessed according to prescribed scientific, ethical and professional criteria and defined standards.
In executing its functions, the Authority may:
- Liaise with any other regulatory authority or institution and may, without limiting the generality of this power, require the necessary information from, exchange information with and receive information from any such authority or institution in respect of –
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- matters of common interest; or
- a specific investigation; and
- Enter into agreements to co-operate with any regulatory authority in order to achieve the objects of the Medicines Act.
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;
- any substance or mixture of substances which, in the course of customary or reasonable handling or use, including ingestion, might, by reason of its toxic, corrosive, irritant, strongly sensitizing or flammable nature or because it generates pressure through decomposition, heat or other means, cause injury, ill-health or death to human beings, to be a Group I or a Group II hazardous substance;
- any electronic product to be a Group III hazardous substance; and
- subject to the approval of the Minister of Mines, any radio-active material to be a Group IV hazardous substance.