Across the African continent, National Regulatory Authorities are implementing track-and-trace systems that use serialisation, blockchain, and digital verification to secure pharmaceutical supply chains. This article maps a summary of the leading countries on who’s doing what, and what it means for the industry.
Kenya: Moving Forward
In October 2025, Pharmacy and Poisons Board (PPB) published its Standards for Authentication and Traceability of Health Products and Technologies, the formal framework for Kenya’s traceability journey. PPB outlined a proposed 3-phase implementation:
- Phase 1 (12-48 months): Establish basic visibility and record capabilities. Data capturing, central batch repository, foundational infrastructure.
- Phase 2 (48-72 months): Unique-level traceability. Serialised numbers for high-risk health products, event-based reporting.
- Phase 3 (72-120 months): Universal serialisation across all product categories. Advanced analytics, including AI for data-driven regulation.
Kenya is aligning with GS1 standards, joining over 70 countries globally, integrating these protocols into their traceability frameworks. KEMSA has already implemented product verification and reporting requirements for public health facilities.
Egypt: Enforcement in Action
Egypt’s traceability programme has moved rapidly from policy to enforcement. The Egyptian Drug Authority (EDA) launched the Unified National Electronic System for Pharmaceutical Track & Trace under Ministerial Decree No. 804/2025 and EDA Decree No. 475 of 2025. Enforcement began on 1 November 2025.
South Africa: A Comprehensive Roadmap
South African Health Products Regulatory Authority’s Traceability Guideline, Implementation Roadmap (Issue No. HPA16-2025/26) is arguably one of the most ambitious pharmaceutical traceability plan in Africa. It mandates a phased transition from batch-level identification to full unit-level serialisation for all health products, including OTC medicines.
Key milestones:
- October 2026: Industry readiness assessment. GS1 membership verification.
- April 2027: Pre-implementation testing. Data-sharing protocols established.
- October 2027: Phase 1 compliance for imports (batch-level identification mandatory).
- October 2029: Phase 1 for domestic products + Phase 2 initiation for imports (unit-level serialisation begins).
- October 2031: Full serialisation required for ALL health products.
All data must be encoded in GS1 DataMatrix (saleable units) or GS1-128 (logistics units), meeting ISO/IEC print-quality standards. South Africa’s framework is setting the standard for the SADC region.
Nigeria: Africa’s Early Mover
National Agency for Food and Drug Administration and Control (NAFDAC)’s Pharmaceutical Products Traceability Regulations 2024 are already in force, making Nigeria one of the first African countries with active traceability requirements. NAFDAC has been a regional leader in anti-counterfeit enforcement for over a decade, and its traceability framework builds on that foundation.
Ethiopia: Blockhain Based Approach
The Ethiopian Food and Drug Authority (EFDA) is taking a distinctive approach: a blockchain-based traceability system. The EFDA-MVC Traceability Hub required registration by July 2025. From June 2026, systems must record traceability events and enable automated reporting. Local production must comply by August 2026.
Ethiopia’s blockchain approach is particularly interesting because it addresses a fundamental challenge: in complex supply chains with multiple intermediaries, blockchain’s distributed ledger provides tamper-proof records that no single actor can manipulate.
Rwanda: Aligning with AMA
Rwanda, host country for AMA headquarters, finalised its traceability guidelines in May 2025. Full implementation is expected between 2027-2028. As the seat of continental regulatory coordination, Rwanda’s traceability system will likely serve as a reference model for other ratifying states.
Zimbabwe: Piloting with UNICEF
The Medicines Control Authority of Zimbabwe (MCAZ) has launched its first traceability pilot using the TRVST application, developed with UNICEF support. The rollout follows a structured 3-stage approach. MCAZ also made history in 2025 by publishing Public Inspection Reports, a transparency measure few African NRAs have adopted.
Algeria: Largest country in North Africa
Algeria’s Medicines Control Agency (MCA) is preparing to implement the DIAMIND Government Solutions system. It recently signed a decree activating the framework for a National Pharmaceutical Traceability System. As North Africa’s largest country, Algeria’s adoption signals momentum across the Francophone regulatory landscape.
The Bigger Picture
Three dynamics are converging:
- The technology is mature. Serialisation (GS1 DataMatrix), blockchain, RFID, and AI-powered nano-scanners are all operational, not theoretical.
Continental coordination is emerging. - AMA’s mandate explicitly includes the coordination of anti-counterfeiting intelligence across borders. The 2020 Lomé Initiative, signed by Congo, Ghana, Niger, Senegal, Togo, and Uganda is the first binding agreement to criminalise the trafficking of counterfeit medicines in Africa.
- Regulatory deadlines are real. Nigeria’s regulations are in force. Ethiopia’s compliance deadline is 2026. South Africa’s roadmap runs to 2031. Kenya’s 3-phase plan is underway. Companies supplying African markets need to plan now.
What this Means for AfriSummit 2026
Pharmaceutical traceability will be a major theme at AfriSummit 2026. We are building sessions that cover the practical realities: what systems are required in each market, how serialisation affects packaging and production lines, and what cross-border enforcement looks like under AMA coordination.
After 5 successful editions, AfriSummit 2026 is coming to East Africa in Nairobi, Kenya. More details to be announced soon. Register your interest to attend today. https://pharmaregafrisummit.com/delegates-register/