Drug labelling has changed over time because of evolving regulations and has increased in content and length, with a standard format to guide the safe and effective use of the drug. Product labels (drug or devices) contain comprehensive information enriched with product details, such as disease indications, target populations, drug-drug interactions, and ADRs. The labels and labelling documents prepared by manufacturers and approved by the Health Authorities, in its final form, reflect the collective input from regulators, drug manufacturers, and scientific experts. Drug-labelling data is an important resource for diverse applications, including support for policy development.
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.