Essential components of a successful global labelling process

The importance of an effective global labelling process can sometimes be overlooked in the wider industry. With the right process in place, sponsors can avoid regulatory delays and streamline complexity for robust labeling. Having an efficient global labelling process in place will help expedite time to market and commercialisation and improve access to patients in need.

Here, we outline essential components for an efficient process to support program success.

Start the labeling process early

Define the product label as early as possible in the drug development process to ensure that the development program generates the appropriate data needed to support the target label. This will also help define ambitious, desirable or undesirable scenarios for the proposed commercial label.

Creating a high-level overview of all applicable product requirements enables categorisation into common and diverging necessities for content and technical requirements. This is a comprehensive starting position to create the desired label.

It is also worth noting that the labelling process itself does not vary greatly between different types of product or regulatory procedures, or for advanced therapies, cell or gene therapies. Such products may have special requirements to label for autologous use or technical requirements to label and supply frozen product, but the labelling process itself is unaffected.

With this in mind, the labelling process needs to start during the drug development process.

Appoint decision makers and experts

Clear roles and responsibilities help to streamline operations and minimise the potential for delays at decision points. Identify and engage the decision makers early in the process. The decision maker’s role is to support the overall program strategy, specific requirements and direction. Make sure the role and area of responsibility are clear for each decision maker involved in the process to ensure endorsements and decisions are made in a timely manner.

Recruit the right subject matter experts (SMEs). The global labelling strategy should be approached holistically. Assemble a specialised regulatory team who will round out a comprehensive global approach, including:

Local insights
Knowledge on regional regulatory requirements
Influential factors and drivers from specific functions, such as supply chain and commercial

Maintain a single source of truth

Within global labelling processes, it is especially important to define the approach to centralise key information that will guide company core, regional and domestic label content. Developing and managing label content in a single location, such as a document management system or regulatory information management tool, ensures harmonisation and ease of access for teams across geographies. This will improve collaboration and allow for centralised decision-making by keeping all relevant information in one place for the team to review and weigh options.

Embed data responsiveness and quality checks

Define steps and required SMEs to address new clinical data or label inputs. Such inputs can result in expedited timelines and potentially earlier approval. Defining these steps may also be critical if there is a need to re-evaluate the development program. Proactively implement this framework to ensure new information, i.e., data read-outs or health authority comments, are addressed quickly and the team maintain focus on the desired label.

Conduct quality control as a consistent step in the label development process. Checking accuracy of data between source and labelling, proofreading artwork against regulatory text, and ensuring the appropriate local templates and guidance is used will minimise delays in finalising the label without compromising the quality of the content. Failure to be proactive in quality control may result in labelling content errors, incorrect information for patients and healthcare professionals, or delays in the ability to supply the product.

Establish a documentation retention approach

Implement a framework to consistently manage agendas, minutes, and RAID logs (Risks, Actions, Issues and Decisions) to ensure transparency, alignment and retention of information for easy project team access and reference. Integrated systems will improve accessibility and support faster, more effective collaboration across the multidisciplinary teams that will input into the label process.

Companies of all sizes and of different specialities benefit from long-term retention of this information. This will ensure that data is always accessible, even if the original project team is no longer available or a product has been transferred to another business.

Conclusion

Operational excellence is the key to delivering an ambitious filing strategy and ultimately creating access to the product for patients.

The labeling process is universal for any research and development program to function well. No matter the regulatory procedure or type of product, including advanced therapies, cell or gene therapies, the labelling process enables companies to respond quickly to new information.

By following the approach outlined here, organisations can create a sustainable labelling framework that eliminates process delays, ensures decisions made during the development process are preserved for future reference, and contributes to enhanced business performance and long-term success.

Connect with us to learn how ICON's Regulatory Consulting Solutions team can assist you in developing an effective filing strategy to set your program up for success.

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Essential components of a successful global labelling process

Start the labeling process early

Appoint decision makers and experts

Maintain a single source of truth

Embed data responsiveness and quality checks

Establish a documentation retention approach

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