As pharmaceutical supply chains grow increasingly complex and global, the need for serialization has never been more urgent. While developed regions like the European Union and the United States have been early adopters of serialization to combat counterfeit drugs and ensure traceability, emerging markets are now stepping into the spotlight, driven by rising healthcare standards, global trade requirements, and regulatory reform. This blog explores how emerging markets are embracing serialization, what challenges they face, and how industry stakeholders can prepare to engage with this fast-changing landscape.
Why Serialization Matters in Emerging Markets
Counterfeit medications are a global crisis, but their impact is especially devastating in low- and middle-income countries. These markets often suffer from fragmented supply chains, weak regulatory oversight, and limited technological infrastructure, creating fertile ground for substandard and falsified medicines.
With globalization and increasing pharmaceutical exports from emerging regions, serialization is now seen not just as a safety measure, but as a passport to international trade.
Countries at the Forefront of Serialization Reform
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Ecuador: Building Traceability Through Gradual Rollouts
Ecuador is implementing serialization with a phased approach, starting with specific therapeutic categories such as oncology and high-cost medications. The country’s regulatory authority, ARCSA, has signaled that digital traceability will become the norm, aligning with broader public health goals.
Key Insight: Ecuador is focusing on interoperability between manufacturers, wholesalers, and pharmacies, prioritizing system integration over rapid implementation.
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Kazakhstan and Uzbekistan: Following the Russian Model
As members of the Eurasian Economic Union (EAEU), both Kazakhstan and Uzbekistan are aligning with a crypto-code labeling model inspired by Russia’s Chestny ZNAK system. These codes combine product information with unique, encrypted serial numbers, allowing for real-time tracking.
Key Insight: Companies operating in these regions must prepare for highly detailed reporting requirements, often involving local data storage mandates and tight timelines.
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Rwanda: A Tech-Forward African Approach
Known for its forward-thinking digital health policies, Rwanda is now applying similar innovation to pharmaceutical traceability. The government is actively partnering with private firms and NGOs to pilot serialization programs for essential medicines and vaccines.
The Ministry of Health of Rwanda has issued guidelines for the identification and labeling of pharmaceutical products. These guidelines include deadlines for master data reporting in 2024 and phased deadlines for barcoding, serialization, and aggregation extending into 2025 and beyond.
Rwanda is currently developing pharmaceutical serialization requirements, with full implementation targeted by 2027. The primary aim of these regulations is to enhance the traceability of pharmaceutical products and combat counterfeit drugs. Key components of these regulations include the gradual introduction of serialization and aggregation processes
Key Insight: Rwanda’s model could become a blueprint for other African nations, as it combines mobile-based verification tools with centralized regulatory oversight.
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Azerbaijan:
Azerbaijan’s serialization journey is still in early stages, but policy frameworks are being discussed in conjunction with customs modernization efforts. The country is focusing on preventing the illegal re-importation of medicines, which has become a significant regulatory concern.
Key Insight: Companies should monitor legislative developments closely, as Azerbaijan is expected to move quickly once the serialization roadmap is finalized.
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Ukraine:
As of March 5, 2025, Ukraine has established a clear timeline for implementing mandatory serialization of medicinal products to enhance the safety and traceability of pharmaceuticals within the country.
Voluntary Phase (Starting January 1, 2026): Pharmaceutical market operators in Ukraine may begin voluntarily applying safety features to medicinal product packaging and utilize the national verification system from this date.
Mandatory Implementation (Effective January 1, 2028): The application of safety features, including a unique identifier and an anti-tampering device, will become compulsory. Medicinal products introduced to the market before this date without these safety features may continue to be sold in Ukraine until their expiration dates.
Key Insights: Ukraine’s framework mirrors the EU Falsified Medicines Directive (FMD), signaling a move toward regulatory harmonization with the EU — a key factor for manufacturers seeking cross-border compliance.
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Zambia:
The strategic plan for 2022-2026 has been devised by ZAMRA to enhance the effective and efficient execution of the Authority's regulatory functions both domestically and internationally.
Additionally, Zambia Medicines Regulatory Authority (ZAMRA) has released a preliminary Guideline on Identification and Labelling of Medicines and Allied Substances as well as Master Data Sharing for public review and input.
This guideline aims to outline the criteria by which the Authority will mandate product labeling in support of their forthcoming pharmaceutical traceability system aligned with GS1 standards. It marks a crucial progression towards establishing pharmaceutical traceability systems.
Common Challenges in Emerging Markets
While the momentum is clear, several shared obstacles stand in the way of seamless serialization adoption:
- Infrastructure Readiness: Many countries lack the digital infrastructure required for real-time data exchange, forcing reliance on manual or hybrid systems.
- Cost Pressures: Small and mid-sized pharma companies often struggle to afford serialization technology, particularly if no government subsidies exist.
- Regulatory Fluidity: Guidelines are frequently revised, and roll-out dates may be postponed due to local political, economic, or logistical constraints.
- Capacity Building: There is a shortage of trained personnel in serialization technology, data handling, and compliance auditing.
Looking Ahead: What to Expect
As serialization becomes a standard part of pharmaceutical regulatory compliance, the next five years will be critical for emerging markets. Expect to see:
- Regional harmonization of regulations (e.g., in Africa and Southeast Asia)
- Public-private partnerships to build serialization ecosystems
- Increased cross-border data sharing and enforcement cooperation
- Expansion of serialization to medical devices, APIs, and over-the-counter drugs
Final Thoughts
Pharmaceutical serialization in emerging markets is not just a trend—it’s a transformation. These countries are no longer passive recipients of global compliance trends; they are active architects of their own systems, often with unique and locally adapted solutions. As the serialization landscape evolves, companies that stay ahead of the curve and invest in regional understanding will be better positioned for sustainable success.
About the Author
This blog was written by CosmoTrace, a pharmaceutical serialization specialist and industry blogger focused on regulatory compliance, supply chain transparency, and digital health transformation. With years of experience tracking global serialization trends, CosmoTrace brings insights to help organizations navigate the ever-evolving regulatory environment.
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