rug discovery, clinical research, therapeutic product development, and their regulation continue to evolve and expand throughout Africa. But are the manufacturing and supply chains in these product pipelines keeping up with this progress? Where can companies invest, take advantage of these growing opportunities, and deliver safe and efficacious products to patients there? Learn more in this Q&A with IFPMA Director, Scientific and Regulatory Affairs, Janis Bernat.
Janis Bernat (JB): The pharmaceutical industry is a key driver of clinical research, with clinical trials underpinning the development of safe, effective medicines and strengthening healthcare systems through high-quality evidence generation. In addition to scientific expertise, the industry brings unique operational readiness built on extensive experience conducting thousands of clinical trials involving large and diverse patient populations under Good Clinical Practice (GCP) conditions. This deep, practical experience in trial design, execution, data integrity, and regulatory compliance represents a distinctive capability that the industry contributes to the clinical research ecosystem.
Across Africa, drug discovery, clinical research, therapeutic development, manufacturing, and patient access are moving in a forward-looking direction. This progress is reflected in the emergence of centers of research excellence, such as the H3D Centre for Drug Discovery, which demonstrate the continent’s growing scientific and operational capacity. More broadly, research activity is expanding across priority areas such as infectious diseases, noncommunicable diseases, vaccines, and oncology. This is supported by growing multistakeholder initiatives, involving patients, multilateral organizations, development banks, government stakeholders, and the biopharmaceutical industry.
Investments in clinical trial site capacity and regulatory strengthening are contributing to a more mature, ethical, and scientifically robust ecosystem, laying the foundation for sustainable innovation and improved patient access over time.
The continent’s untapped potential is evident in its growing clinical trial capacity, maturing regulatory frameworks, and developing network of partners. To name a few, these include the Africa Clinical Research Network (ACRN), EDCTP, and AdVAncIng Clinical TRials Excellence in Africa (AVAREF).
GF: What are some of the major challenges in turning clinical discoveries into clinical care products that can be manufactured by companies in Africa for patient access in Africa?
JB: Turning clinical discoveries into clinical care requires robust clinical trials, efficient regulatory and ethics review, and health-system readiness to deliver innovative therapies safely. While scientific capability and clinical expertise are growing across Africa, progress is often slowed by fragmented and sequential regulatory and ethics approval processes, limited use of risk-based approaches, and insufficient reliance and work-sharing mechanisms.
These challenges can result in duplicative, costly, and time-consuming approval pathways, particularly for multicountry trials, delaying evidence generation and patient access to innovative treatments and discouraging further research investment.
Greater harmonization with international standards, predictable timelines, parallel regulatory and ethics reviews, and wider use of reliance frameworks would significantly accelerate clinical development while maintaining patient safety and data integrity. Recognizing these challenges, we hosted the Africa Regulatory Conference from September through November 2025, creating a dedicated platform for open dialogue among regulators, ethics committees, industry, and other stakeholders to advance regulatory convergence, reliance, and practical, implementable solutions.
GF: Where/what is the biggest opportunity for pharmaceutical/biotech manufacturers in Africa right now?
JB: The biggest opportunity for pharmaceutical and biotech manufacturers in Africa lies in the emergence of a more harmonized and enabling policy environment for scientific innovation, notably through the African Medicines Agency (AMA) and the African Continental Free Trade Area (AfCFTA). Together, they create the conditions for reduced regulatory fragmentation, greater predictability, and scale across markets, enabling Africa’s growing scientific capability to translate more rapidly into patient access and health system impact. There is opportunity to upgrade requirements, digital systems, and skills according to international standards.
Another opportunity is in regulatory reliance. By allowing regulators to leverage scientific assessments from trusted authorities, reliance can reduce duplicative reviews, shorten approval timelines, and make better use of limited regulatory resources, while maintaining high standards of patient safety, quality, and data integrity. IFPMA recently explored a series of principles for effective reliance in clinical trial reviews and consideration for implementing reliance in these reviews.
At the same time, Africa’s pharmaceutical manufacturing potential depends on creating the right conditions for geographically diversified production to succeed. This requires three mutually reinforcing elements. First, a demand-driven market that makes investment viable. Second, the infrastructure to operate—from healthcare systems that can absorb and deliver products to the supply chains and skilled workforce that keep production running. Third, policy coherence: the regulatory frameworks, intellectual property protection, open trade, and legal certainty that give companies the confidence to commit for the long term.
GF: Where and how can IFPMA support the work to overcome these challenges and advance opportunities for manufacturing growth and patient access in Africa?
JB: For those working to improve the clinical research and trials ecosystem in Africa, enhancing the visibility of capacity, fostering trust between researchers, regulators, sponsors, and the community, and increasing investments in ethical clinical trials in Africa all remain critical goals.
IFPMA and its members are already supporting ecosystem development through initiatives such as the ATOM Coalition, Access Accelerated, the African Medicines Agency Treaty Alliance (AMATA), engagement with the AfCFTA Secretariat and AMA, Fight the Fakes, and the H3D Foundation to promote innovation driven in Africa.
With the African Medicines Agency moving towards operationalization, the continent has a chance to accelerate approval timelines and strengthen regulatory processes.
A key priority is better integrating clinical trials into the care continuum and strengthening meaningful engagement with patients and patient advocates. Despite growing research activity, in Africa fewer than 3% of patients participate in clinical trials, highlighting an opportunity to improve inclusion. Industry is increasingly applying diversity by design as a scientific imperative—selecting sites based on disease burden and population relevance, engaging communities to build trust, ensuring culturally appropriate consent processes, and working with patients to define meaningful endpoints. We are contributing to training initiatives supporting operational readiness with our global clinical trialist expert experience.
These efforts help ensure that trials are scientifically robust, ethically responsible, and executed efficiently and safely.