South Africa Profile Updated with the Latest Regulatory Fees

The South Africa profile in ClinRegs has been updated as of March 31, 2025, with the latest information on clinical trial application fees and payment instructions, effective February 13, 2025. (See Regulatory Fees)

Sources Added During this Update:

(Communication) Newly Gazetted Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) (Fees-Info) (February 12, 2025)
South African Health Products Regulatory Authority 

Sources Revised During this Update:

(Guidance) SAHPRA Payment Guideline (G-SAHPRAFees) (Version 9) (February 2025)
South African Health Products Regulatory Authority 

(Regulation) Regulations Regarding Fees Payable in Terms of the Provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) (MRSA-Fees) (Effective February 13, 2025)
National Department of Health