By Nuran Idris, GS1 Global Office, Healthcare, May 2026
Across Africa as around the world, momentum around healthcare track and trace is accelerating. What began as isolated national initiatives has now evolved into a regional movement towards regulatory alignment, digitalization of supply chains and the adoption of global GS1 standards to strengthen patient safety, support local manufacturing and enable cross‑border trade.
A Growing Regulatory Footprint in the Region
Over recent years, Africa has seen a steady increase in countries formally adopting healthcare traceability regulations that reference or require the use of GS1 standards. Today, eight African countries have gazetted regulations supporting GS1‑enabled healthcare traceability, reflecting growing alignment with global best practice and international guidance such as that of the World Health Organisation.
Among the most notable recent regulatory developments are Algeria, Egypt, South Africa and Zimbabwe, all of which have passed healthcare track and trace regulations in 2025. Egypt has adopted serialisation requirements aligned with GS1 standards, with a phased implementation approach proposed by the national regulator. South Africa’s regulation, first drafted in 2018 was approved in 2025 after extensive consultation. Zimbabwe has moved rapidly from draft to approval in early 2025, publishing national guidelines that provide guidance on how the regulator intends to secure local supply chains using global GS1 standards.
While regulation is a critical starting point, implementation is where real impact is achieved. Ethiopia provides a leading regional example of moving from policy to practice. Following the publication of national traceability requirements, the Ethiopian authorities have focused on establishing the operational foundations required for a functioning system.
On the other hand, Nigeria continues with its phased implementation which has been expanded to include maternal and child health products building on an already robust track and trace implementation in the country.
Ethiopia and Nigeria’s experience illustrate an important lesson for the region: successful track and trace systems are not regulatory “checkboxes”, but multi‑year transformation programmes that require coordination between regulators, industry and solution providers.
These developments are not isolated events. They reflect a broader trend across the region, and the world, where regulators are recognising traceability as a foundational building block for supply‑chain security, particularly in the fight against substandard and falsified medicines.
Regional agencies and the push for regulatory harmonisation
An important enabler of this momentum has been the growing leadership of regional and pan‑African agencies, which are helping to elevate the traceability discussion beyond national silos. Initially led by initiatives supported by African Union’s Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD), the increasing focus on track and trace as a critical tool in the fight against substandard and falsified medicines has gained further momentum with the operationalisation of the African Medicines Agency (AMA).
The AMA represents an important development for the region — strengthening regulatory harmonisation, enabling regional dialogue, and providing a platform for sharing experiences and success stories across countries.
For regulators, harmonisation offers clear benefits: reduced duplication of effort, easier information exchange across borders, and better alignment with continental initiatives such as trade facilitation and local manufacturing growth. For industry, it reduces compliance complexity and lowers the long‑term cost of doing business across multiple markets. GS1 standards, designed to be global, neutral and interoperable, provide the practical foundation on which this harmonisation can be built.
A Spotlight on Kenya: A Regional Hub Poised to Lead
Kenya stands out as a particularly important market in this journey. As a regional manufacturing, distribution and logistics hub across pharmaceuticals and other regulated sectors, Kenya is well positioned to move ahead with healthcare track and trace — and to do so in a way that supports both public health and industrial growth.
Nationally, Kenya has already taken meaningful steps, including the publication of improved draft regulations focused on authentication and traceability of health products, alongside structured multi‑stakeholder engagements led by the Pharmacy and Poisons Board (PPB) and other local stakeholders from the government and private sectors. These drafts show clear alignment with regional trends and with the approaches being adopted across more than 70 countries globally that rely on GS1 standards to support healthcare traceability systems.
For Kenyan manufacturers, this development presents a concrete opportunity. Products exported from Kenya to regulated regional and global markets would be labelled using GS1 standards, meaning that early adoption of national track and trace requirements can strengthen market access rather than create a new barrier. In this context, traceability becomes not only a regulatory obligation, but a competitiveness and trust enabler for local industry — particularly for manufacturers looking to grow beyond the domestic market.
Industry Engagement and Knowledge‑Sharing
Industry associations and GS1 Member Organisations continue to play a critical role in translating policy into practical guidance. In Kenya, forums such as the KAPI‑hosted webinar on serialisation and track and trace, as well as GS1‑led webinars and solution‑provider sessions, have provided platforms to unpack regulatory expectations, address implementation concerns, and share lessons from other countries.
These engagements are particularly important in demystifying track and trace. They reinforce that GS1 standards are not technology mandates, but open, widely adopted building blocks that enable interoperability across systems, partners and borders.
The Power of the GS1 Network
Underlying all of these developments is the strength of the GS1 network—locally, regionally and globally. With 120+ GS1 Member Organisations around the world, healthy and vibrant user groups from around the world that help shape the standards, healthy network and collaboration platforms with solution providers and international agencies including other standard development organisations such as ISO, GS1 is uniquely positioned to act as a neutral convener and technical reference point.
This network effect opens doors for deeper collaboration: between regulators seeking peer learning, between manufacturers navigating compliance, and between countries aiming to align their systems over time. As more African markets move from regulation to implementation, this collaborative ecosystem will become even more critical.
Looking Ahead
Track and trace in Africa is no longer a future ambition—it is an active regional transformation. With new regulations in place, frontrunners such as Egypt, Nigeria, Ethiopia demonstrating implementation pathways, regional agencies pushing harmonisation, and hubs like Kenya poised to accelerate, the coming years will be decisive. Through continued collaboration and the consistent use of GS1 standards, the region has an opportunity to build safer, more efficient and globally connected healthcare supply chains.
A Call to Action for Local Industry
For manufacturers, now is the time to engage early — with regulators, with industry associations, and with GS1. Understanding the foundations of track and trace, participating in technical discussions, and planning incrementally will help ensure that compliance pathways are practical, proportionate and supportive of local industry growth. Early engagement matters!
