Building upon Part 1’s exploration of product labelling as a defence against counterfeiting, this article (Part 2) delves into the intricate process of managing pharmaceutical labelling changes, crucial for compliance, minimising waste, and maintaining efficient supply chains across multiple markets.
The seemingly simple act of changing a word or updating a logo on a pharmaceutical component – be it a carton, foil, or leaflet – can trigger a cascade of activities with significant implications. Whether driven by internal rebranding initiatives or mandated by regulatory bodies like the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA), these changes demand meticulous planning and execution across a potentially vast landscape of countries and product variations. Understanding the inherent complexities and implementing robust management strategies are paramount for pharmaceutical companies to navigate this challenging terrain.
The Dual Drivers of Change: Internal Needs and Regulatory Imperatives
Labelling changes in the pharmaceutical industry stem from two primary sources. Internal reasons often involve brand updates, the introduction of new logos, or improvements in the clarity and design of packaging. While seemingly straightforward, these changes can still impact multiple components and require careful co-ordination to ensure brand consistency across markets.
The second, and often more intricate, driver is regulatory requirements. New labelling guidelines, updated safety warnings, or changes in legal text mandated by health authorities necessitate swift and accurate updates. The complexity escalates when these regulatory changes apply to specific countries or regions, potentially impacting shared components and requiring careful differentiation.
The Global Ripple Effect: Navigating Multi-Market Complexity
A significant challenge arises when components are shared across multiple countries. For instance, a German leaflet might serve Germany, Switzerland, and Austria. If a regulatory change is required in only one of these countries, the decision-making process becomes intricate. Companies must determine whether to create country-specific leaflets, potentially increasing costs and complexity, or to implement a change across all shared markets, even if not strictly required. The likelihood of shared components varies by language; while a Portuguese leaflet might theoretically serve Portugal and Brazil, regulatory nuances often necessitate market-specific versions.
Furthermore, a single change request can affect a multitude of components (cartons, leaflets, foils, etc.) and span several regulatory jurisdictions simultaneously, such as the EU, the USA, and individual member states like Germany. This complexity is amplified by the existence of numerous Stock Keeping Units (SKUs) for a single product, encompassing different concentrations, pack sizes, and presentations. A seemingly minor change can therefore necessitate updates across a vast array of materials and markets.
The High Stakes of Non-Compliance: Scrapping and Supply Chain Disruption
The consequences of mismanaging regulatory-driven labelling changes can be severe. Products bearing incorrect or outdated components may be deemed non-compliant and potentially require costly scrapping. This not only results in financial losses but can also disrupt supply chains and potentially lead to product shortages.
A recall announcement in November 2024 from the FDA highlights the critical importance of accurate labelling. The expansion of a voluntary recall of Clonazepam Orally Disintegrating Tablets USP (C-IV) by Endo International underscores the potential for medication mix-ups due to incorrect or missing strength indications on the product label. This type of labelling error can have serious consequences for patient safety, necessitating the removal of affected batches from the market and emphasising the direct link between labelling accuracy and regulatory compliance.
Similarly, in a press release on 17 April 2025 from Medicines and Healthcare products Regulatory Agency (MHRA), patients were urged to check their packs of the blood pressure medicine Lercanidipine due to a labelling error. Certain packs were found to have an incorrect expiry date printed on them. This incident, while seemingly a minor discrepancy, could lead to patients unknowingly using expired medication, potentially impacting their health and highlighting the crucial role of accurate and up-to-date labelling information.
Effective stock management of existing components is therefore critical. Robust systems must be in place to monitor inventory levels and prevent the accumulation of unusable materials as new components are introduced. This requires close collaboration between the Artwork Project Management team and the Supply Chain function.
Deconstructing the Process: From Identification to Implementation
The general artwork change process in the pharmaceutical industry, often incorporating planning stages as seen in companies like AbbVie, typically involves the following key steps:
- Identify the need for change: This initial step can originate from internal stakeholders (e.g. marketing, brand management) or external regulatory bodies.
- Regulatory Authority (RA) negotiation: The RA team engages with regulatory agencies (e.g. the European Medicines Agency (EMA) in the EU, the US Food and Drug Administration (FDA) in the USA) to discuss and gain approval for the proposed change. This stage is often the most time-consuming and is largely outside the direct control of the pharmaceutical company.
- Information transfer to Artwork Project Management Team: Once regulatory approval is secured, the RA team communicates the details of the approved change to the Artwork Project Management team.
- Artwork Studio execution: The Artwork Project Management team then sends the information to an external Artwork Studio, often managed through an Artwork Management System (AMS), to implement the required changes to the artwork files.
- Artwork Project Management Team review: The internal Artwork Project Management team meticulously reviews the updated artwork to ensure accuracy and compliance with the approved changes.
- Supply Chain management: Finally, the Supply Chain team takes over, managing the production of the new components and overseeing their integration into the manufacturing and packaging processes, while simultaneously managing the phase-out of old stock.
Bridging the Information Gap: Addressing Tool Limitations
While Regulatory Information Management (RIM) tools and Artwork Management Systems (AMS) are valuable assets in managing regulatory data and artwork files, they often fall short in directly addressing the process flow and facilitating seamless collaboration between teams with differing levels of detail.
RA teams, focused on the high-level aspects of the change (e.g. “update the warning statement on the Carton”), operate at a different level of granularity than the Artwork Project Management team, which requires specific details about affected SKUs, component codes, and artwork versions. The existing tools, while rich in data management capabilities, may not inherently bridge this information gap or provide a holistic view of the entire change process.
Strategies for Enhanced Process Management
To optimise the management of pharmaceutical labelling changes, companies should consider the following strategies:
- Establish Clear Communication Channels: Implement robust communication protocols between the RA team, Artwork Project Management, and Supply Chain to ensure timely and accurate information flow. Regular cross-functional meetings and clearly defined responsibilities are crucial.
- Develop Standardised Processes: Create detailed, documented workflows for different types of labelling changes, outlining responsibilities, timelines, and approval steps. This provides clarity and consistency across all change initiatives.
- Implement Process-Oriented Tools: Explore or adapt existing tools to incorporate process management functionalities. This could involve customising AMS or RIM systems or integrating them with project management software to track progress, manage tasks, and facilitate collaboration.
- Centralised Information Hub: Establish a central repository for all information related to labelling changes, including regulatory approvals, artwork files, component specifications, and stock levels. This ensures that all stakeholders have access to the latest information.
- Early Planning and Risk Assessment: Proactively plan for potential labelling changes, especially those driven by anticipated regulatory updates. Conduct thorough risk assessments to identify potential challenges and develop mitigation strategies.
- Enhanced Data Mapping: Improve the linkage between regulatory information (managed in RIM systems) and artwork/component data (managed in AMS). This can help to automatically identify affected SKUs and components based on regulatory changes.
- Training and Awareness: Provide comprehensive training to all relevant teams on the labelling change process and the importance of accurate and timely execution.
The Convergence of Authenticity and Compliance
Analysis of Part 1, “The Indelible Mark of Authenticity: The Role of Product Labelling as a Defence Against Counterfeit Product,” highlights the critical role of sophisticated and carefully designed product labelling in safeguarding against counterfeiting. Key themes include the use of overt and covert security features, the importance of consumer trust, and the legal ramifications of counterfeit products.
Discussion:
Considering the insights from Part 1 regarding labelling as a crucial element of product authenticity and security, and the detailed processes and challenges outlined in this Part 2 concerning the management of labelling changes in the pharmaceutical industry, several important points for discussion arise.
How can pharmaceutical companies integrate anti-counterfeiting measures more effectively into their existing labelling change management processes?
What are the specific challenges and opportunities in implementing sophisticated security features on pharmaceutical packaging across diverse global markets and regulatory landscapes?
Furthermore, how can the need for regulatory compliance and the imperative to protect against counterfeiting be balanced to ensure both patient safety and product integrity?
Your thoughts and experiences on these interconnected aspects are welcome.
Thank you for reading.
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References and Further reading
URL https://www.ema.europa.eu/en/
URL https://www.fda.gov/drugs/laws-acts-and-rules/fdas-labeling-resources-human-prescription-drugs
URL https://www.fda.gov/medical-devices/premarket-approval-pma/pma-labeling