The South African Health Products Regulatory Authority (Sahpra) has embarked on an aggressive drive to clear thousands of health products approval applications, with priority given to TB, HIV and oncology therapy.
The body said it inherited the backlog, dating back over two decades, from the Medicines Control Council (MCC), its predecessor.
Of the more than 16,000 applications, 8,300 are new registrations and 7,500 variation applications.
The backlog has had a wide impact on South Africans, it said, including the stalling of innovative products used to treat rare diseases and generic medication that could reduce the cost of treatment considerably.
“Treatment for conditions like asthma, diabetes, cancer and mental health has been affected.”
Portia Nkambule, acting head, said the situation was compounded by Sahpra receiving 4,700 new applications per annum – significantly more than their absorption capacity.
The launch of the backlog clearance programme was a critical milestone in establishing an efficient, effective and sustainable health products regulator, she said.
“This programme will enable access to cutting-edge innovative medicines and affordable generic medicines for all South Africans.
“Sahpra will automate and digitise its application process so as to cope with the anticipated deluge of applications,” Nkambule said.