South Africa Profile Updated

The South Africa profile in ClinRegs has been reviewed and updated with the following information:

• New requirements related to clinical trial application rejection, submission documents, and investigational product (IP) quality information from the South Africa Health Products Regulatory Authority’s (SAHPRA’s) 2023 revised clinical trial application (See Scope of Assessment, Submission Content, and Quality Requirements)
• Additional payment instructions from the 2022 SAHPRA payment guidance (See Regulatory Fees)
• 2024 meeting and submission dates for the SAHPRA Clinical Trials Committee (See Scope of Assessment, Submission Process, and Timeline of Review)
• Requirements regarding the release of IPs from the revised 2023 PIC/S Guide to Good Manufacturing Practice for Medicinal Products, which South Africa adopted (See Quality Requirements)

Sources Revised During this Update:

(Guidance) General Information Guideline (G-GenInfo) (Version 12) (December 2023)
South African Health Products Regulatory Authority

(Guidance) Guideline on the Payment of Fees to SAHPRA (G-SAHPRAFees) (Version 7) (September 2022)
South African Health Products Regulatory Authority

(Guidance) PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-17 (PIC-S-GMP-Guide) (August 25, 2023)
The Pharmaceutical Inspection Co-operation Scheme

(Document) Clinical Trials Committee Meeting and Submission Dates for 2024 (ZAF-11) (Version 1) (October 6, 2023)
South African Health Products Regulatory Authority

(Form) Application to Conduct a Clinical Trial (ZAF-23) (Version 8) (Effective September 18, 2023)
South African Health Products Regulatory Authority

(Form) Notification Studies: Phase IV (ZAF-17) (Version 5) (Effective October 1, 2023)
South African Health Products Regulatory Authority

(Form) Six Monthly Progress Report Form for Clinical Trials (ZAF-18) (Version 5) (Effective September 22, 2023)
South African Health Products Regulatory Authority