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....
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...
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...
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. ...
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)....
This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines. The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...
This document is intended to provide communication to The Holder of Certificate of Registration for Codeine containing products. The Advisory Clinical Committee (ACC) reviewed data submitted by HCRs to support the continued use of codeine in children under 12 years and concluded that there is evidence...
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....
COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...
As you may be aware, SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is planned for new medicinal clinical trial applications for January 2024. The official launch of the system for all new medicinal clinical trial applications will...