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 core.
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, conscientious and socially transformative, globally positioned health products regulator with sustainable positive impact on long and healthy lives of all those living in South Africa.
To safeguard public and animal health by licensing of safe, effective and good quality medicines, medical devices, IVD’s, radiation devices and radioactive materials. Further, to monitor clinical trials, maintain vigilance and ensure regulatory compliance of these health products in South Africa.
Caring about society and the environment: For humans and animals, this involves consideration of our impact on individuals, local communities and on the environment, acting with diligence and sensitivity.
Valuing good work ethics and striving towards service excellence and extroversion. This represents being committed to working with stakeholders and building good relationships with them by understanding them, their needs, responding quickly and providing appropriate solutions that are underpinned by the core mission and values of the organisation.
Treating stakeholders with respect at all times; being helpful, courteous, accessible, responsible and knowledgeable in our interactions; and ensuring that all communication is clear, effective and tailored to the needs of the audience.
Developing robust performance measures, allowing for benchmarking and monitoring challenges and opportunities for growth.
Ensuring that the Board, Authority and relevant stakeholders have clarity on the mandate of the organisation, policies and procedures that underpin their work and clarity of the roles they perform.
Ensuring that all policies, guidelines and procedures are underpinned by the core principles and values of the organisation that are known to all staff of the Authority, Board members and stakeholders, united by a common vision, facilitating collaboration and support, thereby contributing to a beneficial, safe and effective working environment.
Teamwork and cohesion are key and collaboration should include pooling of resources, work-sharing and effective communication.
Fostering professionalism, trust and honesty in interactions with colleagues and stakeholders.
Cultivating an environment where all contributions are valued; everyone is treated consistently and fairly; diverse viewpoints are heard and capitalised on and conflicts are resolved effectively.
Making SAHPRA goals a priority, by targeting and carefully using SAHPRA resources to ensure effective delivery of our work.
Investing in the professional growth of staff through sharing knowledge and experience, peer networking, education through training and creating opportunities to develop. This includes creative problem-solving, informed risk-taking, learning from our mistakes and experiences and behaving professionally.
Managing career pathing, skills development and performance in the workplace with the aim of introducing greater diversity.
Working with academic and training agencies to identify and develop new opportunities for regulatory science training.
Leaders should develop innovative approaches and drive continuous improvement as well as effective and smooth organisational change initiatives.
Influencing and supporting the global regulatory network in which we operate, and promoting harmonisation, whilst ensuring local responsiveness to the evolving needs of our country.
Promoting ideas sharing and supporting innovation, research and development that are in the public’s interest.
Identifying needs related to broad challenges present in society.
Creating an enabling environment for sound, ethical research and backing new ideas by bringing them to the market.
Pursuing cost-effective solutions in operations research and training.
Monitoring and evaluating the impact of interventions on the challenges faced.
Applying new ways of doing things at all levels of the Authority.
Encouraging out-of-the box thinking and rewarding ground-breaking initiatives.
Commitment to ethical conduct by promoting and protecting the health of all who live in South Africa and of its animals through relevant, scientifically sound and ethical regulatory practices.
Working with integrity and responsibility by setting and achieving goals and consistently delivering business results while complying with standards and meeting deadlines.
Ensuring efficiency in the best use of public resources.
Fostering a work environment underpinned by a culture of fairness, impartiality, independence, accountability and transparency.
Ensuring alignment of the Authority’s operational ethos with the principles set out in the WHO Good Regulatory Practice Guideline.
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;