The South African medicines control body is working around the clock to clear a backlog of new licensing, dating back to 1992. South African Health Products Regulatory Authority (SAHPRA) replaced the Medicines Control Council (MCC) last year – from which it inherited the bulk of the backlog.  SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products and clinical trials. Health products include complementary medicines, medical devices and in vitro diagnostics (IVDs). Unlike the MCC, which fell under the department of health, the new entity is a legally structured body that does not fall under the department.

Currently, there are 16,000 applications in need of processing. According to SAHPRA’s head of backlog clearance taskforce Davis Mahlatji, there are 8,300 new registrations and 7,500 variation applications. Processing this timeously has been hindered by the fact that the body receives 4,700 new applications every year. Mahlatji said applications older than five years make up half of the outstanding applications.
“SAHPRA’s largest challenge was an inherited backlog of medical products which are defined as all applications submitted which are yet to receive final approval, including certification,” he said, adding that among the applications are duplicates and clones.

Generic medication

The backlog has affected the market entry of new innovative medical products used to treat rare diseases and generic medication that could reduce considerably the cost of treatment for a variety of conditions. Treatment for conditions like asthma, diabetes, rare diseases, cancers and mental health has been affected. 

Despite not having all the resources needed to ensure this, the regulatory body says it is making good progress. At the current capacity and with the current process it would take about eight years to clear the outstanding applications assuming there are no new applications made.

However, Mahlatji says the SAHPRA Board’s ambition is to clear the backlog within two years – which is why it has launched the ring-fenced backlog project with a dedicated team to reduce the number of applications needing evaluation and segmenting. It will also prioritise applications and design and implement new models for evaluation. Since the beginning of this month, when the project was launched, all pharmaceutical companies are obliged to resubmit their applications.

The first resubmission window includes priority therapeutic areas with high public health needs that have not been met. The authority’s board says it has been working with government to group the applications by therapeutic area and prioritise medicines that will benefit the public health sector. Applications for HIV, tuberculosis, hepatitis and vaccines have been grouped as priority. Other high priority medicines include cancer treatments, infectious diseases, diabetes and malaria.

Priorities

SAHPRA Board chairperson Professor Helen Rees said the authority met with the department of health to discuss public health priorities. “We are looking at what the department feels are public health priorities – and we are making sure that we as a regulator respond to that,” she said.

In order to avoid future backlogs, SAHPRA hosted a workshop for 150 industry representatives to outline the revised evaluation processes.

Portia Nkambule, acting CEO at SAHPRA, described the backlog clearance project as a critical milestone in establishing an efficient, effective and sustainable health products regulator in South Africa. 

“This will enable access to cutting-edge innovative medicines and affordable generic medicines for all South Africans and [ensure the] growth of a thriving local pharmaceutical industry. In an era of the Fourth Industrial Revolution, SAHPRA will automate and digitise its application process so as to cope with the anticipated deluge of applications,” she said. – Health-e News