South African Health Products Regulatory Authority (SAHPRA) Gauteng, South Africa
SAHPRA is responsible for regulating all health products, including medicines, medical devices, and radiation equipment. Its role is to ensure the safety, efficacy, and quality of health products available in South Africa.
Welcome to South African Health Products Regulatory Authority (SAHPRA)
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.
Evaluation of new applications and peer reviewing of new applications, Evaluate applicant responses for registration/approval of medicines, Technical screening for the quality and efficacy
Evaluation of quality variations for small molecule product applications and peer-reviewing of these applications, Write reports and draft query and approval/rejection letters after evaluation, Technical screen and evaluate the quality and efficacy
Evaluation and peer-reviewing of renewal applications: Evaluate and generate evaluation report(s) for renewal applications (generics) in compliance with required template and adopted regulatory and scientific standards as per Good Manufacturing Practice (GMP) Pharmaceutical Inspection Co-operation Scheme (PIC/s) guidelines