SAHPRA Annual Report 2018-19

22 Oct 2019
SAHPRA publishes its Annual Report 2018-19

SAHPRA Sets the Record Straight

22 Oct 2019

The South African Health Products Regulatory Authority (SAHPRA) notes with concern the statement made by Knowledge Bylanes South Africa and more recently Business Day.



19 Oct 2019

In February 2019 the South African Health Products Regulatory Authority (SAHPRA) received reports suggesting fraudulent activity implicating a small sector of the authority and an external stakeholder. SAHPRA’s acting-CEO, the Board and the Health Minister reported the allegations to the Special Investigating Unit (SIU) and therefore welcomes today’s proclamation by President Cyril Ramaphosa authorising the SIU to investigate these matters.



SAHPRA Announces New CEO

03 Oct 2019
SAHPRA is pleased to announce the appointment of a new Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, who will commence with this role in January 2020.

API names updated to align with WHO INN

02 Aug 2019

Update - 
SAHPRA has updated and amended the approved South African API names to bring them in line with WHO INN.

The amendment process allows for a five-year transition period to allow industry to bring medicine labelling in line with the policy commencing in June 2019 and ending in June 2024. 



Submission of Business as Usual (BAU) registration and variation applications

01 Aug 2019
To Industry Partners

The aim of this communication is to guide industry regarding the submission of BAU registration and variation applications for human medicines (excluding Complementary Medicines).

Publication of final versions of various guidelines

05 Jul 2019
SAHPRA is pleased to announce the publication of multiple guidelines (including Tranche 1 and Tranche 2 documents). Thank you to industry for your comments, which were duly considered. Please note that the implementation date of the Professional Information (PI) and Patient Information Leaflet (PIL) Guidelines is contingent on regulation amendments currently out for comment. The implementation date of the Variations Addendum is contingent on the go-live of the Digital Variations Portal. Development of the portal is underway, and additional communication will follow. Timelines for submitting in eCTD and eSubmission format will be detailed in the Roadmap (2.26), an updated version of which will be published shortly.


10 May 2019
SAHPRA is the South African Health Products Regulatory Authority formaly known as the Medicines Control Councel (MCC).  
Click here to find out more about SAHPRA as the new regularor.



The Medicines Control Council applies standards laid down by the Medicines and Related Substances Act, which governs the manufacture, distribution, sale, and marketing of medicines.
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Acts, regulations, notices, registrations, application forms, guidelines, safety alerts and workshops are available for download when selecting the publications section.
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