Archive

All guidelines adopted by the South African Health Products Regulatory Authority (SAHPRA) from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) must be read in conjunction with the current, non-draft version of SAHPRA’s Guide to Good Manufacturing Practice for...

SAHPRA intends to declare medicines compounded in terms of Section 14(4) of the Medicines Act containing Glucagon-Like Peptide-1 (GLP-1) Active Components or a combination of Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide agonist (GIP) Active Components undesirable in terms of Section 23 of the Medicines...

The South African Health Products Regulatory Authority has experienced challenges in exercising its function to review and stamp the documents of incoming shipments of medicines, medical devices and scheduled substances at the OR Tambo International Airport port of entry. The delay has been caused by a...