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 as well as for drug imports and exports.
The direct impact of this is 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 serialisation 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.
He added that for countries that have yet to implement serialisation 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 serialisation domain.
While much of the impetus around serialisation comes from Europe and North America, many countries in the Asia Pacific and the 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 serialisation becomes more penetrated in Europe and North America once deadlines are reached, specialist software companies offering serialisation will start focusing their efforts on the much more fragmented markets in the APAC and ROW regions.
This research analyses past, present, and future timelines for implementation of serialisation 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 serialisation. 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 serialisation deadlines approach, software companies offering in-line and enterprise-level serialisation 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.
Haider observed that serialisation 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 can learn lessons from the rollout in Europe and North America to accelerate their timeline.
“This can be done 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,” he concluded.