The South African Health Products Regulatory Authority (SAHPRA) is committed to upholding the highest standards of regulatory excellence. Central to this commitment is our ISO 9001 certified Quality Management System (QMS), which ensures that all operational and regulatory activities are well-structured, standardised, and aligned with international best practices and statutory requirements to protect public health.
This certification underscores our adherence to Good Regulatory Practices (GRP) and global benchmarks in quality and efficiency, while also reflecting our dedication to providing transparent, reliable, and high-quality regulatory solutions that address the needs of the public and industry stakeholders. Embracing a culture of continuous improvement, SAHPRA regularly evaluates and enhances its systems and processes to maintain excellence in every aspect of its work.
The South African Health Products Regulatory Authority (SAHPRA) is responsible for the: 1) Regulation of health products intended for human and animal use; 2) Licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nuclides; and 3) Conduct of clinical trials.
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