South Africa Updates
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 ...
South Africa Profile Updated in ClinRegs
May 27, 2021 - The South Africa profile in ClinRegs has been reviewed and updated to include the following:
Updated information on the South African Health Products Regulatory Authority (SAHPRA) (See Regulatory Authority)
Updated information on clinical trial fees and payment instructions (See ...
South Africa Profile Updated in ClinRegs
Jun 19, 2020 - With this South Africa update, the NIAID ClinRegs Team pays tribute and honors the memory of our friend and collaborator, Gita Ramjee, who passed away in March. Gita directed the South Africa Medical Research Council clinical trials unit in Durban for many years. She had a tremendous passion ...
South Africa: SAHPRA Revises GCP Training Requirements and Issues Clinical Trial Application Guidance for Public Health Emergencies
Apr 16, 2020 - On April 13, 2020, the South African Health Products Regulatory Authority (SAHPRA) issued GCP Training and Expedited Review of Clinical Trial Applications during COVID-19 Pandemic. The notice states that SAHPRA has amended requirements for in-person good clinical practice (GCP) training ...
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