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With support from Germany and the European Union, the South African Health Products Regulatory Authority (SAHPRA) is in the midst of a digital transformation which will significantly improve operational efficiency and deepen integration with partners in Africa and beyond.

The South African Health Products Regulatory Authority (SAHPRA) is a young agency with an ambitious vision: ‘We want to become a leading regulator that enables greater access to medicines and fosters collaborations that improve regulatory capacity on the African continent,’ says Dr Boitumelo Semete-Makokotlela, SAHPRA’s Chief Executive Officer.

Established in 2018 as the successor to South Africa’s Medicines Control Council, SAHPRA is in the midst of a far-reaching institutional modernisation process whose aim is to produce an agile and responsive organisation fully at home in a fast-paced, interconnected world. High on the agenda is seeing through a comprehensive digital transformation that will enable SAHPRA to turn the page on a largely manual work environment – think spreadsheets, time-consuming payment reconciliations and siloed business processes – and to begin executing its mandate with the advantages of an integrated digital system behind it.

Not only will this greatly improve day-to-day efficiency, but it will also help SAHPRA in its bid to attain ‘maturity level four’ status – the top designation issued by the World Health Organization in its global benchmarking of regulatory systems. In a region where many national regulatory authorities only partially fulfill essential regulatory functions, this global recognition could position SAHPRA to play a key role in improving access to medicines and vaccines both within South Africa and beyond its borders, via harmonised regulatory agreements.

African countries work to reduce dependence on imported pharmaceuticals

The efforts underway at SAHPRA are just one part of a larger movement to strengthen the local production of vaccines and pharmaceuticals on the African continent. African countries import 99 percent of the vaccines they use, and between 70 and 100 percent of finished pharmaceutical products. The consequences of this were particularly evident during the COVID-19 pandemic, when people in countries across Africa struggled to access essential medicines and gained access to vaccines later than many living in other parts of the world.

In 2021, determined to change this situation, African heads of state set a target that 60 percent of the continent’s vaccine requirements should be produced locally by 2040. International partners, including Germany’s Federal Ministry for Economic Cooperation and Development (BMZ) and the European Union, are supporting the achievement of this goal through regional and bilateral measures which follow an ‘ecosystem approach’ to strengthening local vaccine and pharmaceutical value chains. This includes training skilled workers, broadening access to financing, building demand for locally produced products, and strengthening regulatory bodies, such as SAHPRA, which are responsible for assuring the quality, safety and efficacy of health products.

Local manufacturing needs a robust regulatory environment

‘Strong regulators are essential for pushing local manufacturing of vaccines and medicines forward,’ explains Claudia Aguirre, head of the Vaccines for Africa: Roll-out and Production in South Africa (SAVax) programme which is implemented by the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) on behalf of BMZ, with co-financing from the Team Europe Initiative MAV+ project. SAVax has been supporting SAHPRA since 2022 with the implementation of its ‘digital roadmap,’ as well as with training measures to improve specific regulatory competencies.

‘SAHPRA’s role is to ensure that medical products manufactured here and exported onto the African market are of good quality,’ says Claudia Aguirre. Beyond this ‘guardian function’, however, high-performing regulators are also important in terms of setting up reliance mechanisms – agreements by which countries with less developed regulatory regimes trust the work and decisions of those with more developed systems. ‘SAHPRA is an active participant in the African Medicines Regulatory Harmonisation  (AMRH) initiative and is working closely with the other five “maturity level three” regulators in Africa to develop a reliance mechanism,’ explains Dr Semete-Makokotlela.

Harmonisation initiatives like these are another major focus of the SAVax programme. ‘When regulatory regimes are harmonised, it makes imports and exports much more efficient,’ according to Claudia Aguirre. ‘This is why private sector actors involved in the local manufacturing ecosystem are excited about the changes underway at SAHPRA.’

SAHPRA tackles inherited operational challenges

Upon its creation, SAHPRA inherited from the Medicines Control Council a backlog of approximately 16,000 health product applications and a set of administrative systems which were no longer able to deliver milestones in the regulatory review process in a timely manner.

SAHPRA’s dynamic, female management team recognised that for the authority to be a trusted regulator, both domestically and internationally, it had to shed these operational challenges and become a more nimble and streamlined institution. This meant introducing a culture of quality and continuous improvement, prioritising sound financial management and tackling digitalisation.

According to Christelna Reynecke, SAHPRA’s Chief Operating Officer, a core problem has been that the software systems used to manage the authority’s 35 different business processes are not compatible. This leads to a lot of manual data entry, which undermines accuracy, and also makes it difficult to generate reports quickly. Lack of automation has been another challenge. Basic steps, such as granting approval to submit an application, take up to 10 working days. Payments for service fees must be individually reconciled. There are no automated updates for applicants about the status of their pending applications.

‘It can be challenging for industry stakeholders who rely upon decisions from SAHPRA to plan their production and delivery cycles,’ explains Phyllis Njiru, a senior technical advisor with GIZ in the SAVax programme. ‘When there is a lack of information about the timeline for regulatory changes or amendments, production bottlenecks and stock-outs can result. Patients who need access to medications and treatments are the ones who are ultimately affected.’

A digital ‘one-stop shop’ set to streamline engagement

This situation is about to change – and in a big way. ‘We expect that digitalisation will make us about 40 per cent more efficient as a regulator,’ says Christelna Reynecke.  

After several years of incremental investments and a lot of behind-the-scenes re-engineering, the centerpiece of SAHPRA’s new IT system is nearly complete: a public-facing customer portal which stakeholders from the pharmaceutical industry, academia, the health sector and other parts of government will be able to use to initiate applications, upload documentation, receive notifications about queries which must be addressed, report adverse reactions in patients, apply for import licenses, make payments and track the progress of their applications through the different stages of the regulatory review process.

On the back end a digital management system will streamline SAHPRA’s workflows, using Application Programming Interfaces (APIs) to connect different software solutions with a data warehouse. Management and staff will be able to use data analytic tools to visualise information and generate reports to inform decision-making.

User account registration for the new portal opened in November 2024 and the portal is expected to go live in April 2025, initially for two categories of applications: Health Product Applications (for the registration of new products or amendments to existing registrations) and so-called ‘Section 21’ applications (for emergency use of a particular medicine on compassionate grounds). By March 2027 each of SAHPRA’s other business processes – from the registration of clinical trials and licensing of manufacturers, to the issuance of import-export permits and monitoring of drug safety (pharmacovigilance) – will be digitalised and docked on to this foundation.

An investment with far-reaching benefits

The SAVax programme has played a key role in bringing this vision to fruition. Since 2022 it has provided support for the software development processes required to transition away from legacy systems and to knit together the various digital elements into an interoperable whole. ‘The support we’ve received from SAVax has been the catalyst for our digital transformation,’ explains Christelna Reynecke. ‘Many partners have supported us to address aspects of our digital roadmap. The partnership with GIZ has allowed us to deal with our whole problem, and not just pieces of it.’

The expected benefits are far-reaching. Technical staff at SAHPRA will be able to concentrate on the substance of their work, rather than on administrative tasks. And some administrative personnel will be upskilled and redeployed into new roles – a ‘win-win’ situation for a public agency with constraints on its human resource headcount.

Digitalisation will also help to integrate SAHPRA more closely with key regional and international institutions. Compliance requirements with respect to monitoring bodies, such as the International Narcotics Control Board, will be greatly eased. It will become possible to exchange information seamlessly with entities such as the new African Medicines Agency and VigiBase, the WHO global database on adverse event reports for drugs and vaccines. All of this will assist SAHPRA in its quest for ‘maturity level four’ status and ultimately to become a WHO Listed Authority – potentially the first regulatory authority in Africa to achieve these designation.

‘We have a busy schedule ahead of us for the next few years,’ Christelna Reynecke acknowledges. ‘Time is of the essence. We’ve seen what “curveballs” like a pandemic can mean, and how important it is as an institution to be agile, responsive and able to move.’

Karen Birdsall
December 2024