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This document has been archived....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This document has been archived....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...
29 May Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant
Posted at 22:05h
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This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....
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....
10 Mar Comm Issue No.PEM01-CEM01-2025 – Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)
Posted at 09:27h
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This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all applicants/Holders of Certificates of Registration (HCRs) who intend to submit/have submitted applications supported by bioequivalence studies conducted by Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located...
28 Jan Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant
Posted at 20:41h
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This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines. Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...
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. ...