31 Jan Regulations Relating to Medical Devices and In-Vitro Diagnostic Medical Devices (IVDs)
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Archive
03 Oct Medicines Online Directory Toolkit
Posted at 10:47h
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SAHPRA has launched an Online Medicines Directory. Please visit: www.medsinfo.sahpra.org.za The Online Medicines Directory has been launched for Schedule 0-2. The job is to increase awareness and use of the directory amongst consumers, patients and healthcare providers. This toolkit provides Market Authorisation Holders (MAH) and SAHPRA...
11 Sep A Primer for Clinical Assessors within African Regulatory Agencies
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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
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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...
07 Oct Annual Report (2021/2022)
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Report types
PDF versionInteractive version...
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....