28 Aug SAHPRA Backlog Project – the three pronged approach
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SAHPRA Backlog Project – the three-pronged approach
Pretoria, 22 August 2019 – The South African Health Products Regulatory Authority (SAHPRA) aims to clear its backlog within a period of two years. The backlog clearance programme went live on 1 August 2019. One of the critical priorities of the South African Health Products Regulatory Authority (SAHPRA), since its launch in February 2018, has been the clearance of its medical products backlog. SAHPRA has developed a detailed strategy to clear this “inherited backlog”, defined as all applications submitted which are yet to receive final approval (including certification), as of 31 January 2018.
SAHPRA inherited the backlog from its predecessor, the Medicines Control Council (MCC), and dates back to 1992. This includes approximately16 000 applications: 8 300 new registrations and 7 500 variation applications. This is exacerbated by SAHPRA receiving 4
700 new applications per annum that is significantly more than the absorption capacity. To prevent future backlogs, the general principle is that all revised policies and processes that apply to the Backlog Clearance Program will also apply to business as usual (BAU) – that is all applications received from 1 February 2018. As such, The Backlog Project will run in parallel with the Business-As-Usual (BAU) process.
The backlog clearance project will assume a three-pronged approach:
-Reducing the number of applications that require evaluation
-Segment and prioritize remaining applications
-Design and implement new models for evaluation
Priority will be given to public health need, ensuring that high priority ailments are given attention. Ailments such as Tuberculosis, HIV, and oncology, among others, will be prioritised.:SAHPRA will also piggy back on the World Health Organisation’s (WHO) and mature regulatory authorities. In this way time is saved by not having to go through the entire evaluation process, thereby fast-tracking the application process.
The backlog project is a ring-fenced project with a dedicated team assigned to this project. Approximately 150 industry representatives attended a SAHPRA workshop on 23 July 2019 to learn about the re-engineered evaluation processes All pharmaceutical companies will be obliged to
re-submit their applications as at 1 August 2019 when the project went live officially.
The first resubmission window includes priority therapeutic areas with high unmet public health need: all HIV, TB, Hepatitis, and Vaccines applications, and high priority NCE applications “The launch of the Backlog Clearance Program represents 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 growth of a thriving local pharmaceutical industry. In an era of the 4th Industrial Revolution SAHPRA will automate and digitise its application process so as to cope with the anticipated deluge of applications,” indicates Portia Nkambule, Acting CEO at SAHPRA.
Ms Portia Nkambule
012 842 7582/7583
Mr Yuven Gounden
012 842 7628
083 297 1214
For more information:
079 503 5139