SAHPRA is an entity of NDOH created by the SA government to ensure that health and well-being of humans and animals health are at its core.
The South African Health Products Regulatory Authority (SAHPRA) is the national regulatory authority responsible for the regulation of health products in South Africa. SAHPRA ensures that all health products marketed in South Africa meet the required standards of safety, quality, efficacy, and performance. It plays a crucial role in protecting public health by regulating medicines, medical devices, radiation emitting devices, and in vitro diagnostics.
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SAHPRA regulates all medicines to ensure they are safe, effective, and of good quality before they can be sold in South Africa.
Regulates medical devices to ensure they meet the required safety and performance standards.
Oversees the approval and monitoring of clinical trials to ensure ethical standards and participant safety.
Protects public health by ensuring that health products do not pose a risk to the population.
Issues licenses to manufacturers, wholesalers, and distributors of health products.
Monitors compliance with health product regulations and takes enforcement action when necessary.
Collects and analyzes reports of adverse events related to health products to identify and mitigate risks.
Provides information and education to the public about health products and their safe use.
Collaborates with international regulatory authorities to enhance the regulation of health products.
Develops policies and guidelines to improve the regulation of health products in South Africa.
Located in Pretoria, South Africa.
Operates under the Medicines and Related Substances Act, 1965 (Act 101 of 1965).
To be a world-class regulator of health products, ensuring their safety, efficacy, and quality for the South African public.
To protect and promote public health through the effective regulation of health products.
Integrity, Excellence, Transparency, Accountability, and Collaboration.
Available on the official website for public inquiries and reporting.
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