12 Jan Clinical Trial Insurance for New Clinical Trial Applications
Posted at 13:26h
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This document has been archived....
Archive
05 Jan Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting
Posted at 15:09h
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This document has been archived....
18 Nov Core Business Escalation Procedure
Posted at 10:18h
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This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
17 Nov Clinical Trials Committee Meeting and Submission Dates for 2026
Posted at 13:45h
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Applicants are advised to submit clinical trial applications before the due date. Applicants submitted after the due date will not be accepted....
29 Sep Communication to Industry – Pilot: Clinical Trial Applications Electronic System
Posted at 15:48h
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This communication is issued in view that SAHPRA has embarked on a process to digitalise its business processes and need to pilot the electronic process. The pilot is planned for new medicinal clinical applications for the month of October 2025, with the official launch of...
10 Mar Clinical Trials Conduct – USA Government Funding Pause/stop
Posted at 10:33h
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This communication is issued given the current uncertainty about US government funding for healthcare in South Africa, particularly in clinical research, and it intends to emphasise the responsibilities of various stakeholders in Clinical Trials....
14 Oct Clinical Trials Committee Meeting and Submission Dates for 2025
Posted at 11:54h
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This communication is for Stakeholders to be aware of SAHPRA's Clinical Trials Committee meeting dates and the submission dates for the year of 2025. ...
25 Sep Clinical Trial Applications – Investigational Product Import Licence
Posted at 09:33h
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This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....
30 Apr South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic
Posted at 11:33h
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This communication intends to clarify the expectation for Good Clinical Practice (GCP) training post COVID-19 pandemic and supersedes the communication dated 13 April 2020 regarding online SA GCP training....
02 Jan COVID-19 Clinical Trials – Two-Weekly Progress Reports
Posted at 11:30h
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COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...