The South African Health Products Regulatory Authority (Saphra) has a backlog of six years, with more than 16 000 medicines on its waiting list that needs to be approved.
Saphra is responsible for issuing approval of medical devices and medicines.
More than half of those applications are for new registrations of medicine already available and in use for patients overseas.
Rare Disease SA chief executive Kelly du Plessis says drugs need to be approved in order for medical aids to be able to pay for them.
Basically, patients cannot access the treatment that they need for the fact that they can't have them paid for because they are not registered products.— Kelly du Plessis, Chief executive - Rare Disease SA
A lot of work needs to be done to make sure that this backlog is approved.— Kelly du Plessis, Chief executive - Rare Disease SA
According to Du Plessis, Saphra's inherited the problem from the previous regulatory body, the Medical Control Council.
She says many patients with rare diseases die while waiting for these medicines to be approved.
To hear the rest of the conversation, listen below:
This article first appeared on CapeTalk : Thousands of medicines on approval waiting list may put patients' lives at risk