South Africa Updates
South Africa Profile Updated with Revised Data Protection Regulations and Related Sources
Nov 18, 2025 - The South Africa profile in ClinRegs has been updated as of October 16, 2025 to include 2025 amended regulations and sources related to the protection of personal information. (See Personal Data Protection)Sources Added During this Update:(Document) ASSAf POPIA Compliance ...
South Africa Profile Updated with the Latest Regulatory Fees
May 28, 2025 - 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 ...
South Africa Profile Updated
Jan 17, 2025 - The South Africa profile in ClinRegs has been reviewed and updated with the following information:Updated ethics in health research guidelines from the National Department of Health (See the Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Specimens topics)2024 ...
South Africa Profile Updated
Dec 18, 2023 - 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 ...
South Africa Profile Updated
Apr 26, 2023 - The South Africa profile in ClinRegs has been updated to include the following information:
South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting and application submission dates for 2023 (See Scope of Assessment, Submission Process, and Timeline ...
South Africa Profile Updated
Sep 26, 2022 - The South Africa profile in ClinRegs has been reviewed for accuracy and updated with the following information:
Updated SAHPRA contact information (See Regulatory Authority)
Updated application to conduct a clinical trial and updated application for a protocol amendment to an approved ...
South Africa Profile Updated in ClinRegs
Nov 5, 2021 - The South Africa profile in ClinRegs has been reviewed and updated to include the following:
The 3rd edition of the South African Good Clinical Practice: Clinical Trial Guidelines
Updated safety reporting timeframes, including for foreign reports of safety issues in multi-country ...
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