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Conversation highlights:
SAHPRA published a local manufacturing policy in June 2025 that prioritizes applications from domestic pharmaceutical manufacturers and waives priority review fees.
The agency is piloting parallel reviews with WHO for vaccines manufactured in South Africa to reduce approval timelines and support local production capacity.
South Africa has developed new capacity for locally manufactured in vitro diagnostic tests and vaccine production, capabilities that were crucial during COVID-19.
The African Medicine Agency will drive regulatory harmonization across the continent, like the European Union model for drug approvals.
AI and digitalization present major opportunities for regulatory efficiency, particularly given resource constraints facing African regulators.
Strong regulatory systems and local manufacturing capacity are essential for Africa's pharmaceutical sovereignty and economic development.
EF: One of your top priorities has been supporting local manufacturers. Can you walk us through your local manufacturing policy and how this objective has evolved?
DBS: We published our local manufacturing policy in June of 2025, and it's now available on our website. The policy prioritizes applications from anyone manufacturing pharmaceutical products in the country, so they don't have to follow the normal queue. We also waive the specific fee we usually charge for priority reviews. This represents a significant shift in how we support domestic manufacturing capacity and pharmaceutical sovereignty.
EF: How do you see the balance between innovative medicines and improving access through biosimilars and generics in the South African market?
DBS: From a regulatory perspective, one of the major developments we're piloting is parallel reviews with WHO for vaccines manufactured in South Africa. This should significantly reduce the time applicants need to get WHO prequalification. We're also continuing to support and participate in the African Medicine Agency, which will be crucial for regional harmonization and market access.
EF: What would be an ideal public-private collaboration model that benefits most stakeholders?
DBS: We regulate the industry, so our engagements must be carefully structured to avoid conflicts of interest. We have quarterly meetings with the industry on operational matters and twice-yearly strategic sessions with CEOs of all pharmaceutical and medical technology companies in South Africa. These forums allow us to discuss strategic matters about the country while maintaining appropriate regulatory distance.
EF: After seven years in your position, what do you consider the two greatest achievements in South Africa's life science ecosystem?
DBS: The first major achievement is developing the capacity for locally manufactured in vitro diagnostic (IVDs) tests. We registered several during COVID-19 IVDs, creating pandemic preparedness capabilities we previously lacked. The second is the significant progress in local vaccine manufacturing and other pharmaceutical products.
EF: What should the sector focus on as we approach 2030?
DBS: We must continue focusing on local manufacturing to ensure sovereignty and independence. When faced with public health threats, our domestic industry needs to be able to respond effectively. However, local manufacturing requires regional integration for procurement because South Africa is a relatively small market. Companies need export opportunities and regional government procurement. Integration at the SADC level and mechanisms like pooled procurement will be essential. We also need continuous strengthening and integration of the health system.
EF: Could Africa develop a regulatory system like the European Union for drug approvals?
DBS: That's exactly what the African Medicine Agency will be driving, a centralized and harmonized approach to ensure timely access to safe, quality, and effective life-saving health products. This harmonization approach would allow approvals in one country to facilitate access across the continent, like the European model. You need strong regulators across the continent to support pharmaceutical development and ensure patient safety.
EF: How does SAHPRA assess technological innovation and digitalization in South Africa's pharmaceutical industry?
DBS: Technology plays a massive role in our sector's transformation. AI is a major focus. Everyone is considering and implementing it. We want to integrate AI into our operations, but we're also seeing it deployed throughout the health sector, which means we must be prepared to regulate AI as a medical device. The ECTD submission portal we launched is part of our broader digitalization efforts to accelerate approvals.
We're very excited about AI's potential because we constantly battle resource constraints and undercapacity. Where you have these limitations, AI becomes an extremely helpful tool for regulatory efficiency and effectiveness.
EF: What skills are you prioritizing when hiring for the future of healthcare regulation?
DBS: The key areas are software developers, data analysts, and bioengineers. Software development is particularly critical as we advance our digital capabilities and integrate new technologies into our regulatory processes.
EF: What makes South Africa an attractive investment destination from a regulatory perspective?
DBS: Africa remains a priority for many countries. There's significant continental interest for various reasons. From a pharmaceutical perspective, we have the most established industry on the continent. While we can't compare to Europe or the Americas, we have quite an established industry, excellent science capabilities, and a strong clinical trial infrastructure. For any drug development work, South Africa becomes quite important.
EF: What achievement would you celebrate at the end of this year?
DBS: If we could finalize the vaccine reviews with WHO PQ under our parallel review process, that would be a tremendous celebration. This represents a major step forward in our regulatory capabilities and support for local manufacturing.
EF: What message would you like to deliver to the pharmaceutical sector?
DBS: South Africa is open for investment. We have the foundations to deliver on that investment through our existing companies and strong regulatory framework. Investment support for regulators to strengthen health systems is crucial because you need a healthy nation to drive a strong economy. You cannot have economic strength without a healthy population.
