The South African Health Products Regulatory Authority (SAHPRA)
Medical Products Backlog Clearance Strategy
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 (including new registrations, variations, duplicates, clones, multiple doses and different dosage forms) submitted which are yet to receive final approval (including certification), as of 31 January 2018.
At its formation, SAHPRA inherited a backlog of ~16,000 applications – over 8,000 new registration applications and just under 8,000 variation applications. For new registrations, this backlog goes back as far as 1992 and 50% of these applications are at least 5 years old. Generic applications comprise >90% of the new registration backlog. 15 Active Pharmaceutical Ingredients (APIs) comprise 16% of the new registration backlog, each averaging 20 applicants.
Given the magnitude of this inherited backlog, if SAHPRA maintained current capacity and current processes, it would take 8 years to clear the backlog – assuming no new applications. This challenge is 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 intends 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 has committed to clear the backlog within 2 years. This ambition highlights that the backlog is not just an administrative challenge; it represents a public health crisis. There are three pillars to SAHPRA’s backlog clearance strategy:
- Reduce the number of applications that require evaluation
- Segment and prioritise remaining applications
- Design and implement new models for evaluation
Given the ambitious timeline to clear the backlog, it is necessary to partner with industry to reduce the number of applications requiring evaluation. Three levers will be used in combination. First, as 50% of new registration applications are at least 5 years old, industry will need to ‘opt-in’ for applications submitted in 2013 or earlier. These older applications are more likely to be out-of-date / in an old format, of less commercial interest to industry, and / or of less importance to public health.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 is launched, industry will have 2 months to notify SAHPRA of their intention to ‘opt-in’ using a survey template. If no ‘opt-in’ is received, these older new registration applications will be eliminated from the backlog. Second, for these pre-2014 applications – and for all other new registration and variation applications – applicants will be required to consolidate, update and re-submit these applications to ensure SAHPRA evaluates the most up-to-date information. All variations should be included in this latest information, as should required reliance and summary documents. Finally, all poor quality applications will be rejected. Strict quality standards will be published and made transparent by SAHPRA, similar to other regulators’ submission or acceptance checklists.
The second pillar of SAHPRA’s backlog clearance strategy is 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, will determine the order in which
applications will be evaluated. Public health risk will determine the evaluation pathway. This will be 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 involves new models for evaluation. These new models will also be applied to “business as usual” (beyond the inherited backlog) to improve SAHPRA’s absorption capacity going forward. SAHPRA has adopted new evaluation policies and will rely on several stringent regulatory authorities: US FDA; EMA; Japan MHLW; SwissMedic; Health Canada; Australia TGA, and United Kingdom MHRA. SAHPRA will continue to be part of Zazibona and WHO PQ.
SAHPRA will also formalise different processes to operationalise these reliance models: full review, abridged review, verified review, recognition and notification. Implementation of these new policies will be accompanied by a renewed level of operational excellence, including:
- Streamlined processes – upfront administrative and technical screening, batch processing by API, top-down summary-enabled approach to full reviews
- Optimal staffing – with a dedicated backlog clearance team (separate to ‘business as usual’) and new positions such as Application
- Managers who will have end-to-end responsibility for an application’s progress
- Digitally empowered approach to evaluation – all re-submitted / updated applications to be in eCTD or eSubmission format
- Improved transparency and accountability
- Effective change management
Implementation of the strategy will comprise three phases. Objectives of Phase 1 are to engage with industry, secure funding, detail operational implications, and initiate a program management office (PMO). Phase 2 will commence once funding has been secured. Industry will begin consolidating their applications in line with the requirements in Pillar 1. In addition, pilots of the new processes will be launched and the dedicated backlog team will be recruited. From January 2019, the dedicated backlog team will ‘go live’ whilst the current SAHPRA organisation will form 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 requires unprecedented collaboration amongst all stakeholders in South Africa's health system. The backlog is not just administrative, it is a public health challenge and will require trade-offs and compromises from all parties. SAHPRA will continue 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 will be released in due course.
SAHPRA looks forward to continued support from all stakeholders to achieve the ambitious goal of clearing the backlog in two years. This will lay the foundations for establishing an effective, efficient and sustainable health products regulator in South Africa.
Frequently Asked Questions
SAHPRA Backlog Clearance Programme