A big part of the problem is the way content interdependencies are managed– i.e. how a change anywhere along the safety-regulatory-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 labeling 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 labeling activities.
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 labeling 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, labeling 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 labeling 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.
Portals Are Not The Whole Answer
One approach Life Sciences companies have taken to manage labeling changes, is to create data-exchange portals between global and local functions – so that the different points in the international labeling management chain can collaborate and report back on requirements and related progress. But even this relies too heavily on manual updates and process repetition.
And none of this takes into account the fuller safety-regulatory-manufacturing-supply chain continuum. Complete labeling traceability, for compliance, reporting, and safety/risk management, depends on content and processes being open to easy scrutiny right from one end of the chain to the other - from a safety signal, to the regulatory submission and approval, through to product receipt by pharmacies or hospitals.
True end-to-end label and product tracking and change management ideally needs to encompass artwork updates, and follow-through into and beyond warehouses. While, up to now this broader perspective and ambition remains largely aspirational, achieving complete end-to-end traceability and control is something Life Sciences organisations are increasingly attuned to in their vision for process improvements.
Preparing For The Future
To keep pace with regulators’ growing safety controls and electronic data submission requirements, companies must upgrade their approach to labeling management with some urgency now. Many already have 3-5-year change programs underway, with the aim of establishing holistic, transparent and connected global label management environments.
These comprehensive plans are encouraging, paving the way for a definitive source of labeling truth, in the form of central master data - from which everything else flows. They allow for intelligent workflow - as an efficient and reliable means to assess the impact of label changes/calculate interdependencies; to drive through changes with reduced manual intervention; and to facilitate greater collaboration across departmental, country and supply-chain boundaries.
Ideally, plans should be cross-functional too. They should allow for connection with global ERP/manufacturing systems; inclusion of local stakeholders in any tools and processes; and future automation – for instance, structured authoring of labels and patient information built from approved master content assets. Investment programs should factor in everything from how country-specific requirements are captured, the knock-on effect of changes across the global organization, and the interplay of different operational functions, to the potential for content re-use once approved ‘fragments’ or blocks of text/icons/images are filed in the master repository.
Want to read more from Cwienczek on connected labeling? Read her article in PharmaTimes, click here.
Agnes Cwienczek has been in the position of Senior Life Sciences Consultant for Amplexor since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management. Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization. She was responsible for implementing and maintaining the regulatory applications and data management strategy and roadmap, and ensure business operation of applications under her responsibility, and to lead a global team of regulatory operations experts. Agnes received her master’s degree in Information Management from the University of Koblenz-Landau.