The global labelling management process continues to be a burden on the life sciences industry and is multiplying at a pace that is already becoming increasingly difficult to manage. Firms’ R&D ambitions are growing, businesses are expanding into multiple markets, and regulators are steadily strengthening safety requirements to protect patients and public health. The pharmaceutical industry operates on a global scale, and regulatory compliance across multiple geographies is fundamental to ensuring that the supply chain remains safe and secure.

As part of the dossier registration, all manufacturers must submit labelling support documents (USPI, SmPC, PIL, IFU, etc.) to HAs to grant marketing approval. Each time the benefit and risk profile or safety factors change, or as regional or local regulatory agencies update their standards, international biopharmaceutical firms must react swiftly with accurate, compliant labelling for all affected markets. This is a real-time and hectic process for multinational companies as there are major content interdependencies. Moreover, managing the local label changes (CCDS vs USPI, SmPC & other local labels) with company core safety information i.e. how a change anywhere along the safety-regulatory-manufacturing-supply chain continuum will affect all label content, from the global core datasheet, to patient-facing product information in each marketed country.

Though the manufacturers shall update and distribute the final updated labels where the products are being marketed. Where submissions are bundled and/or split at the country level to comply with local regulations or company’s internal needs and strategies, there are further considerations as companies try to maintain trace ability especially as changes trickle down to dependent countries. The traditional way of managing all of this has been via a combination of specific systems and manual processes. Typically, tracking of label status and changes are done in Excel spreadsheets internally, and content has been updated on a country-by-country basis using dedicated, often standalone labelling tools.

Triggers for labelling changes can occur at different points during product life cycle. Changes to the benefit/risk profile of a drug that require revised labelling requirements from the company’s global core data sheet or local regulatory changes to specific countries can drive the need for a two-way amendment in the supply chain.. As a result, central labelling teams have not found it easy to build up a clear, accurate, and comprehensive picture of all labelling activities. Nor are they able to manage these systematically, end to end, irrespective of where the trigger for a change to the content might come from. In other words, it is difficult for them to efficiently map country/label interdependencies so that changes can be rolled out promptly and reliably wherever the new requirements apply.

In addition to the risk of non-compliance, all of this adds up to a laborious and cost-laden workload for life sciences organisations, as they try to keep track of the latest implemented labels in all of their markets and roll out each new set of changes, as applicable, within the required timeframe. To keep up with the ever-changing emerging safety regulations, companies must upgrade their approach to labelling management with some urgency now.

A modern label management system manages the entire label lifecycle, offers complete transparency throughout the label production process, and facilitates quality control procedures during its distribution. The best modern label management systems now allow business users to design, review, track, and control label data from a document management system. This increases traceability and eliminates scope for errors in the labelling documents for compliance procedures.

Many bio-pharma companies are now looking to ensure compliance, minimize the need for relabeling, and reduce the number of label templates, and transition from paper-based catalogues to digital document management systems. It makes sense to ensure labelling technology is a priority so it can address inconsistencies in processes, mitigate human errors. Timely tracking thus improves business agility for companies to produce compliant, high-quality labels in a cost and time-efficient manner.

Pharma companies, especially those operating from a particular geographical source, will need to rearrange and upgrade their existing labelling processes and compliance structures to conform to the constantly evolving regulatory guidelines. Since details vary from region to region, companies must facilitate tracking units across the supply chain.

LABELai: A Complete Labelling Solution

Automation reduces human intervention and ensures the development of high-quality deliverables that significantly reduce overall operational costs and improve the time-to-market across regions. Some organizations have developed and streamlined the labelling process to minimize the errors, but they often lack the automation required to build a robust and error-free process.

LABELai uses advanced technology to offer end-to-end product labelling by leveraging artificial intelligence (AI) for 90% of the activities. LABELai has been developed with the intention of meeting regulatory requirements in labelling documents, as well as clients’ prospects during the product life cycle management. Our Labelling tool can do the effective process (tracking) for multiple versions of the same document. LABELai has a provision to track the status of labelling documents from production to final distribution and its life cycle management. By using the LABELai tool you can know the label status at any time during drafting, review, approval, and distribution. Corresponding changes to labels along with justifications for changes can also be tracked using this system.

EFFICIENT COMPLEXITY MANAGEMENT

Complexity arises when the source of interdependency remains unknown. It is obvious that one nation is dependent on the other for certain labeling conventions but it becomes difficult to trace particularly which two nations are interdependent and for what reason. It is really necessary to keep a track of all these details as the changes in labeling are generally country-specific and they may arise at any point all through the drug cycle. A single change, maybe about the risk or benefit will result in a series of changes all through the labeling cycle. There would be a change to the core data and at the same time, there would be some changes in the labeling patterns of the markets dependent on these. So it is always necessary to remember that labeling content management can be ensured by catering to the changes on time.

PORTAL CREATION TO MINIMIZE COMPLEXITY

This is an innovative approach that Life Science organizations have initiated to cut complexity. The sole intent of such portals is to enable data exchange at the global and local levels. It is thought that through these portals, all the international labeling units would be able to collaborate. This collaboration would ensure that they are well informed about the changes that are being implemented on the global and local scale. In addition to this, it would make it clear that the changes in labels are done within the stipulated time without hampering the entire procedure. The major setback to this is that the updates that are being done on the portal are manual and there are high chances of repetition.

Portal creation is not the ultimate solution to this issue of pharma labeling complexity because it does not ensure end-to-end tracking. It order to attain more safety and lesser risks, it is necessary that all the product details with regards to labeling and the changes should be tracked accordingly. In order to improve the process of labeling by minimizing complexity, the creation of portals is not enough. It is really necessary to have an organized system that will not only track all the changes that are being made in the regulations but will also ensure that this information gets relayed to all the member countries.

GETTING FUTURE READY

In order to cope with the rapid changes in the field of life science, the system of labeling needs upgrading. Certain organizations are already on the move and they have almost prepared their change programs with a timeline of 3-5 years. The main aim of this change is to create a system that would be transparent, connected at all level and even provide a holistic solution. The creation of the central master data would ensure that keeping a track of everything else would become easier. This data tracks the impact that a change in label might have and also helps in ascertaining the interdependencies. Moreover, this process is less time consuming and involves a lesser manual process and offers greater collaboration within supply chains, across departments and on a cross-country basis.

In this situation of transformation, the complexity arising out of connected labeling will sustain. Still the initiatives that are being taken by the labeling firms are quite apt as they make accession of a huge amount of data possible globally. It is yet to reach the ideal scenario where cross-functionality would be necessary. The introduction of a program that would be catering to all the labeling needs should include the necessary details, the changed regulations, list of the interdependent countries and even the changes undertaken by the major global organizations. All these would make sure that the level of complexity associated with connected labeling will get reduced.