South Africa’s new regulation - S

The new authority replacing the Medicines Control Council is expected to clear a backlog of more than 2,000 applications

South African Health Products Regulatory Authority (Sahpra), have replaced the Medicines Control Council (MCC) with effect from June 1.

Before that, the MCC could not regulate medical devices and complementary medicines, as the MCC could only deal with medicines.

The government has signed the Medicines and Related Substances Amendment Act of 2008, but the Health Minister has to point to a board to get the body to operate.

Sahpra is the solution that the Health Department wanted to take to deal with the delay caused by the MCC, as it took much longer in approving new medicines and clinical trials compared to the US or EU. Sahpra will also regulate foodstuffs, cosmetics, disinfectants and diagnostics.

"Sahpra’s new structure will follow a similar model to the US Food and Drug Administration in that it will be more independent than the MCC." "It will only be partially funded by the government with approximately 70% of funds coming from industry bodies, which will not only enhance the entity’s ability to attract and retain the necessary skills and resources it requires to function optimally, but is critical to its success.", said Erik Roos, Pharma Dynamics CEO.

Sahpra is hoped to be efficient and modernized, however, South Africa’s poor operational environment and meager access to healthcare cannot give it a higher ranking than the other regions.


Do not hesitate to contact us for any questions, prices or timelines in the registration process.