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...
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....
The objective of this guideline is to provide X-Ray equipment licence holders on how and where to dispose of electronic equipment that has reached the end of life. The unit must be confirmed to be in a state where it will never be used for...
In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of...
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....
Adverse Drug Reactions and Quality Problem Reporting Form - for both public and private sector and includes herbal products....
Takeda (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), wish to inform you about the risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation of anagrelide hydrochloride....
Risk of serious adverse reactions, including encephalopathy, associated with MAXIPIME (cefepime hydrochloride) particularly in patients with renal impairment who received doses that exceeded the dosage recommendations. ...
Aspen Pharmacare, Brimpharm SA (Pty) Ltd, Adcock Ingram Limited, Sandoz SA (Pty) Ltd and Takeda (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you of the risks related to the use of valproate containing medicines (sodium...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA) Novartis, Litha Pharma and Aspen Pharmacare, would like to remind you of the following labelled safety information regarding the safe use of clozapine as contained in: ...