Backlog Clearance Project

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 developed a detailed strategy to clear this “inherited backlog”, defined as all applications (including new registrations, variations, duplicates, clones, multiple doses, and different dosage forms) submitted which were yet to receive final approval (including certification) as of 31 January 2018.

At its formation, SAHPRA inherited a backlog of approximately 16,000 applications – over 8,000 new registration applications and just under 8,000 variation applications. For new registrations, this backlog went back as far as 1992, and 50% of these applications were at least 5 years old. Generic applications comprised more than 90% of the new registration backlog. Fifteen Active Pharmaceutical Ingredients (APIs) comprised 16% of the new registration backlog, each averaging 20 applicants.

Given the magnitude of this inherited backlog, if SAHPRA had maintained its current capacity and processes, it would have taken 8 years to clear the backlog – assuming no new applications. This challenge was compounded by a shortfall in absorption capacity, where SAHPRA’s predecessor, the Medicines Control Council, historically received 4,700 applications per year but was only able to register 2,600. Therefore, SAHPRA intended to make an innovative step change to rapidly clear the inherited backlog whilst simultaneously transforming its operating model to improve its ongoing absorption capacity.

SAHPRA’s Board committed to clear the backlog within 2 years. This ambition highlighted that the backlog was not just an administrative challenge; it represented a public health crisis. There were three pillars to SAHPRA’s backlog clearance strategy:

Given the ambitious timeline to clear the backlog, it was necessary to partner with industry to reduce the number of applications requiring evaluation. Three levers were used in combination. First, as 50% of new registration applications were at least 5 years old, industry needed to ‘opt-in’ for applications submitted in 2013 or earlier. These older applications were more likely to be out-of-date, in an old format, of less commercial interest to industry, and/or of less importance to public health. Once this program was launched, industry had 2 months to notify SAHPRA of their intention to ‘opt-in’ using a survey template. If no ‘opt-in’ was received, these older new registration applications were eliminated from the backlog. Second, for these pre-2014 applications – and for all other new registration and variation applications – applicants were required to consolidate, update, and re-submit these applications to ensure SAHPRA evaluated the most up-to-date information. All variations were to be included in this latest information, as were required reliance and summary documents. Finally, all poor-quality applications were rejected. Strict quality standards were published and made transparent by SAHPRA, similar to other regulators’ submission or acceptance checklists.

The second pillar of SAHPRA’s backlog clearance strategy was to segment and prioritise all applications by public health need and public health risk. Public health need, according to government priority therapeutic areas and unmet medical need, determined the order in which applications were evaluated. Public health risk determined the evaluation pathway. This was based upon the type of application and complexity of evaluation required in addition to the level of prior scrutiny by recognised regulators. The third pillar involved new models for evaluation. These new models were also applied to “business as usual” (beyond the inherited backlog) to improve SAHPRA’s absorption capacity going forward. SAHPRA adopted new evaluation policies and relied on several stringent regulatory authorities: US FDA; EMA; Japan MHLW; SwissMedic; Health Canada; Australia TGA, and United Kingdom MHRA. SAHPRA continued to be part of Zazibona and WHO PQ.

Implementation of the strategy comprised three phases. Objectives of Phase 1 were to engage with industry, secure funding, detail operational implications, and initiate a program management office (PMO). Phase 2 commenced once funding was secured. Industry began consolidating their applications in line with the requirements in Pillar 1. In addition, pilots of the new processes were launched and the dedicated backlog team was recruited. From January 2019, the dedicated backlog team ‘went live’ whilst the current SAHPRA organisation formed the business as usual team to evaluate applications submitted from 1 February 2018. Given the size and history of SAHPRA’s inherited backlog, a pragmatic approach to its clearance required unprecedented collaboration amongst all stakeholders in South Africa’s health system. The backlog was not just administrative, it was a public health challenge and required trade-offs and compromises from all parties. SAHPRA continued its extensive stakeholder engagement over the coming months with industry, government, health and patient advocacy organisations, development partners, and the media. More detailed timelines and guidelines for industry were released in due course.

On the 2nd of December 2022, SAHPRA celebrated the end of the backlog project. SAHPRA hosted an event at its offices in Loftus Park, Arcadia, Pretoria to mark the conclusion of the project. The keynote address was delivered by Dr Nicholas Crisp, Deputy Director General: National Health Insurance (NHI) on behalf of the Health Minister, the honourable Dr Joe Phaahla. This event was an opportunity to thank the myriad of stakeholders, without whom this achievement would not have been possible. SAHPRA’s collaboration with both industry and various stakeholders was pivotal in ensuring the success of the project.