Serialization: A Critical Component for the Pharmaceutical Supply Chain in an Era of Item-Level Track and Trace
As regulations evolve to prevent counterfeit medicines, facilitate drug recall, and prevent reimbursement fraud, players throughout the pharmaceutical supply chain are adjusting to the regulatory changes and adopting technology that meets the legal baseline both for domestic drug production and drug imports and exports.
This directly impacts greater supply chain traceability, but implementations also lay the groundwork for full supply chain visibility, a growing topic of interest for pharmaceutical networks worldwide.
“The EU’s FMD (Falsified Medicines Directive) and the US’s DSCSA (Drug Supply Chain Security Act) are the primary drivers of supply chain adoption for serialization solutions, which means that navigating a complex-web of regulations on a short timeline is critical for firms across the value chain wishing to access these large pharmaceutical markets.”
In new research on asset visibility in the pharmaceutical supply chain, global technology intelligence firm ABI Research has identified the regulatory changes which are driving serialization in the pharmaceutical industry, dividing the regulatory landscape into 4 world regions: Europe, North America, Asia-Pacific, and Rest of the World. As regulations evolve to prevent counterfeit medicines, facilitate drug recall, and prevent reimbursement fraud, players throughout the pharmaceutical supply chain are adjusting to the regulatory changes and adopting technology that meets the legal baseline both for domestic drug production and drug imports and exports. This directly impacts greater supply chain traceability, but implementations also lay the groundwork for full supply chain visibility, a growing topic of interest for pharmaceutical networks worldwide.
“The EU’s FMD (Falsified Medicines Directive) and the US’s DSCSA (Drug Supply Chain Security Act) are the primary drivers of supply chain adoption for serialization solutions, which means that navigating a complex-web of regulations on a short timeline is critical for firms across the value chain wishing to access these large pharmaceutical markets”, explains Abdullah Haider, IoT Markets Analyst at ABI Research. “For countries that have yet to implement serialization mandates, the insight of other regional countries that have already done so serves as a blueprint for companies that can better anticipate future regulatory changes in the serialization domain.”
While much of the impetus around serialization comes from Europe and North America, many countries in the Asia Pacific and Rest of the World regions are looking to roll-out their own systems to avoid being left out of the lucrative pharmaceutical market. ABI Research sees emerging countries paying particular attention as they seek to develop this industry, while other countries with more established industries such as China and South Korea also aim to tackle the challenge. As the market for pharmaceutical serialization becomes more penetrated in Europe and North America once deadlines are reached, specialist software companies offering serialization will start focusing their efforts on the much more fragmented markets in the APAC and ROW regions.
This research analyzes past, present, and future timelines for implementation of serialization solutions, key data requirements, level of responsibility of different actors along the supply chain, and methods of data collection and storage. In addition, the research looks at the implications and complexities of aggregation when required in addition to serialization. GS1 forms the basis of most national and regional implementation requirements, moving a step closer to a standardized data-gathering approach on data throughout the supply chain. As serialization deadlines approach, software companies offering in-line and enterprise-level serialization solutions, as well as the broader pharmaceutical ecosystem, can leverage this information to understand a crucial source of supply chain visibility data.
Companies leveraging aggregation will find it easier to realize efficiency gains by implementing a more granular and localized recall, as well as by simplifying how they meet regulatory verification requirements as drug products move through the supply chain. Aggregation will spread because of the value of the parent-child relationship between the carton (parent) and secondary-level packages (child) contained within the carton.
“The serialization regulations are transforming pharmaceutical supply chains. While the regulatory environment in both North America and Europe is relatively certain, and implementation is mostly in place, countries in Asia-Pacific and Rest of the World can learn lessons from the rollout in Europe and North America to accelerate their timeline by addressing hurdles such as data storage and aggregation, laying a deep foundation for supply chain visibility that can be leveraged for many more use-cases beyond the initial regulatory compliance layer,” Haider concludes.
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