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updated – Roadmap and transitional process for the Regulation of complementary medicines

Home >  updated – Roadmap and transitional process for the Regulation of complementary medicines

27 Jan

Posted at 08:18h in

A clone is defined as an application submitted by the Innovator as a copy of its own product under a different proprietary name at any stage during the product life cycle. A replica is defined as a copy of an already registered generic product,...

27 Jan

Posted at 08:17h in

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...

27 Jan

Posted at 08:16h in

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...

27 Jan

Posted at 08:14h in

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...

26 Jan

Posted at 14:30h in

This document has been prepared to serve as a guideline to enable the direct payment of fees into the bank account of SAHPRA. It must be read together with the relevant Fees Regulations and the General Information guideline....

26 Jan

Posted at 14:03h in

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....