SECTION 21 Tag

3 September 2021 The South African Health Products Regulatory Authority (SAHPRA) is aligned with the United States Food and Drug Administration (USFDA) call to not use Ivermectin for the treatment of COVID-19. This stance is reflected in the SAHPRA statement, dated 28 January 2021, outlining SAHPRA’s views on Ivermectin and the Controlled Compassionate Use Programme.  SAHPRA...

19 March 2021 SAHPRA has implemented a new and improved online submission portal for Section 21 applications (Category A Medicines). This has been in development over the past few months. The new submission portal will improve the communication timelines between SAHPRA and applicants. It also allows the...