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The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and...

The notice of concern for the above registered products refers. The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all sartan-containing medicines with the following Active Pharmaceutical Ingredients; azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan and...

This document has been prepared to serve as a guideline for applicants/investigators who wish to submit the application to conduct a clinical trial, application for additional sites, and additional investigators for an approved trial....

To all Applicants: Kindly note that COVID-19 Clinical Trial Applications do not follow the above predetermined submission due dates. They can be submitted to SAHPRA at any time. The last COVID-19 CTC meeting for 2022 is on the 09 December 2022 and the submission due...