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.