Regulations emerge and shift with continuous innovation in the pharmaceutical space, and the creation of new regulations stemming from technological innovation is no different. As regulatory standards, structure and the searchability of regulatory filings and submissions continue to improve through ongoing initiatives, health authorities like the U.S. Food & Drug Administration (FDA) and Health Canada have incorporated new protocols to guide companies in the transition.

Overcoming the regulatory and operational challenges in pharmaceutical labeling requires a comprehensive and strategic approach. Companies need to develop a robust regulatory intelligence system to stay informed about evolving regulations and ensure compliance with the varying requirements of different regions and regulatory agencies. This includes investing in advanced labeling technology that facilitates accurate translation, localization and adaptation of labeling content while maintaining consistency across languages and cultural contexts. Additionally, effective change management processes must be established to manage labeling updates throughout a product’s lifecycle, including formulation changes, new indications, or packaging modifications.

Regional regulatory obstacles in the labeling process

The challenge in labeling compliance and accuracy lies in the variances of regulatory requirements that differ from country to country, as well as the rapid pace at which new regulatory standards are introduced on a regular basis. Differing requirements across health agencies, evolving regulations, safety and risk communications, localization and translation and change management are some of the major challenges within the regulatory process.

Each region and regulatory agency has specific and individual requirements for labeling. Health Authorities such as the European Medicines agency (EMA), the U.S. FDA, Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan all have varying labeling regulations. Navigating through these differences and ensuring compliance can be an extraordinarily complex and time-consuming process. The difficulty is not only to maintain compliance with each agency’s requirements, but also to stay up to date with any revisions to guidelines. Maintaining compliance and accuracy post-approval is one of the most critical aspects of the process. Any changes, updates or variations to the original label submitted may require notification or even additional submissions to regulatory agencies. Agencies typically update labeling requirements to increase patient safety, streamline information and incorporate any emerging technologies, so companies need to ensure that all labeling practices can adapt to evolving regulations to remain compliant.

When communicating the risks and benefits of a product, there are requirements for concise and clear communication. Factors such as label language, comprehensibility and format are all emphasized by regulatory agencies. Careful implementation and adherence to the safety and risk communication requirements can be difficult to manage; with globally marketed products, translating labels accurately to different languages and cultural contexts poses challenges. Label information is required to stay consistent when translated into a local language, so teams need to be extremely detail-oriented throughout the process. The product and safety information needs to be equivalent in meaning for all labeling information, and ensuring this accuracy within a local context requires incredibly careful coordination as well as an abundance of resources.

Pharmaceutical products may undergo changes through the lifecycle with new indications, formulation alterations or packaging modifications. Managing labels or artwork changes, as well as ensuring that every shift is implemented across all product presentations and is communicated both internally and externally, is another hurdle facing labeling teams.

Addressing operational challenges in labeling

On the operational side, challenges emerge such as data management, version control & traceability, collaboration and communication, and supply chain management.

The labeling process requires a large amount of data and information around product dosages, warnings, indications, implementation details and tracking. For companies with vast product portfolios, managing this data can be a major impediment, specifically ensuring the accuracy, accessibility, and consistency of this information. Similarly, label and artwork supply chain management can be a major obstacle; proper inventory management, the timely availability of packaging and label materials and collaboration with external vendors or manufacturers can be operationally damaging in the packaging process.

To prevent omissions, errors, or outdated product information from entering the market, proper version control and traceability of all drafted labels and artwork is critical. There are multiple versions of product documentation throughout the product lifecycle, and teams must manage and document any revisions or changes made. Coordination between all teams and stakeholders involved in labeling, such as quality assurance teams, medical affairs teams, regulatory affairs teams, and marketing teams, is key for dealing with tight timelines and frequent product label updates. The collaboration and communication between these groups can be a challenge, especially as they may operate across multiple distinct locations.

Future labeling shifts

In the future, the field of pharmaceutical labeling is poised for significant shifts driven by advancements in technology. Automated proofreading tools will become more prevalent, reducing the risk of human errors in labeling content. These tools will utilize artificial intelligence and natural language processing to identify and correct potential mistakes, ensuring the accuracy and consistency of label information.

Structured content authoring for labels will also become standard practice. This approach involves organizing labeling content into structured data elements, allowing for greater flexibility, reusability and consistency across different products and regions. It enables efficient updates and revisions by modifying specific data elements without the need for manual rewriting of the entire label.

Automated label comparison tools will play a crucial role in the future of labeling. These advanced software solutions will enable automated comparison of labeling content against different labels and regulatory requirements, ensuring compliance with regional guidelines. This will streamline the review process, identify potential gaps or inconsistencies, and facilitate efficient corrections to maintain compliance.

Furthermore, automation is revolutionizing the tracking of labels from creation to distribution. Automated end-to-end tracking systems are monitoring the entire labeling journey, from content creation to final product packaging. This technology is providing real-time insights into the location and status of labels, improving efficiency, and reducing the risk of errors or delays in labeling operations.

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Rama Mohan Rao Chikkam is IQVIA’s Senior Director of Global Regulatory Operations and APAC Regulatory Affairs and Drug Development Solutions, focusing on leading the GRA-India division for Global Regulatory Services and Technology. He acts as the business domain expert between Regulatory Affairs and IT divisions for implementing RA Life Science IT tools and driving change for global operating models by connecting technology with pharma’s strategic priorities.