Archive
11 Sep A Primer for Clinical Assessors within African Regulatory Agencies
Posted at 10:25h
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Regulatory agencies on the African continent are beset by critical skill shortages caused in part by a lack of resources and training. While some of these issues are being addressed by the regulatory agencies themselves, there exists an urgent need for targeted training for clinical...
04 May SAHPRA Annual Performance Plan 2023– 2024
Posted at 09:42h
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This Annual Performance Plan (APP) for the 2023/24 financial year that has been developed by SAHPRA, represents the planned actions of the Board of SAHPRA to ensure that through their considered and responsible actions, they can, together with the staff at the Authority, assure and...
20 Sep Over-arching: Good Review Practice Guide
Posted at 10:10h
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This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...
08 Sep Extension on commentary period for Borderline Products Guideline
Posted at 09:23h
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Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....
29 Aug Missing Applications – Call to Industry
Posted at 08:49h
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Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....
12 Aug SAHPRA Digital Transformation – Deployment of a Stakeholder portal
Posted at 17:24h
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In keeping with SAHPRA’s strategic objectives – Digital Transformation has been a key focus are for SAHPRA ICT....