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Business as... However much improved life sciences firms are in their approach to regulatory information management, labelling continues to buck the trend. Siloed systems and an over-reliance on manual checks continue to incur risk, delay and cost, especially across international operations. In this article, Amplexor senior life sciences consultant Agnes Cwienczek advises on an alternative way forward.
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abelling management is increasingly becoming a point of pain that life sciences companies cannot ease with existing approaches. Failure to respond quickly to changing product information or market requirements can result in delays to market, or rejected product registrations, with an impact on sales, revenues and market profile. A major sticking point is the way content interdependencies are managed– i.e. how a change anywhere along the safetyregulatory-
manufacturing-supply chain continuum will affect all label content, from the global ‘core data sheet’, to patient-facing product information in each country. More often than not, label status tracking still happens in Excel spreadsheets or home-grown systems, with content updated on a country-by-country basis using dedicated labelling tools. These are rarely connected to companies’ registration and submission planning and management tools, preventing a clear line of sight, and management capability, across all labelling activities. BRINGING ORDER TO INCONSISTENCY The main challenge is companies’ inability to efficiently map country/ label interdependencies, so that changes can be rolled out promptly and reliably wherever new requirements apply. This is often far from straightforward Latin American countries, for example, may be dependent on Europe for labelling convention for tablets, but on US product information for medicinal solutions.
Where submissions are bundled and/or split at country level in order to comply with local regulations or company internal needs and strategies, there are further considerations as companies try to maintain traceability – especially as changes trickle down to dependent countries. And of course, labelling changes can be triggered at different points in the drug ecosystem. While a change to the benefit/risk profile of a drug will drive revised labelling requirements from the global core of the organisation, regulatory changes local to a reference country can drive a need for amendments both up and down the chain – up to the core, and down to dependent markets. So any solution cannot be one-directional in its treatment of cascading changes. BEYOND THE PORTAL APPROACH One approach life sciences companies have taken to manage labelling changes, is to create data-exchange portals between global and local functions – so that the different points in the international labelling management