Global labelling management: why does it continue to cause problems?
In contrast to other areas of regulatory information management, labelling continues to stand apart as a disconnected tangle of systems and processes which lack any real consistency across the global business. Over-reliance on manual tracking, checks and edits risk the introduction of risk, delay and cost. AMPLEXOR’s Agnes Cwienczek offers some pointers on how to put this right.
The global labelling management burden in life sciences is multiplying at a pace. Firms’ R&D ambitions are growing, businesses are expanding into more markets, and regulators are steadily strengthening safety requirements to protect patients from harm.
Each time that the benefit/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. If they fail to do so, they risk delays to shipping or even to keeping their product registrations on the market, with implications for sales, revenues and reputation. Finding a solution sooner rather than later has become a priority, then.
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.
The traditional way of managing all of this has been via a combination of legacy, purpose-specific systems and manual processes. Typically, tracking of label status and changes has happened in Excel spreadsheets or home-grown systems, and content has been updated on a country-by-country basis using dedicated, often standalone labelling tools. Even where such applications include some level of monitoring facility, the value of this has been limited by the fact that labelling tools are rarely - if ever - connected to companies’ registration and submission planning and management tools.
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.
The risk of persisting with existing approaches is non-compliance, and the practical implications of this. These include delays to market and the very real possibility that product registrations could fail or be reversed. If the requirement is an urgent safety change – that a pack must carry a new warning, or a new contraindication must be included in the leaflet -- companies must respond with effective action within 30 days for instance. The timescale for safety-related changes is often strictly regulated, leaving little room for negotiations in the event that companies lack the 360-degree visibility across their global operations, or effective controls, which render them unable to perform a rapid and comprehensive impact assessment.
The ripple effects of changes aren’t consistent, either, which further adds to labelling complexity. Latin American countries, for example, may be dependent on Europe for labelling convention for tablets, but on US product information for medicinal solutions. These jurisdictional variances in determining which guidance to follow, and precisely what to include, add to the management burden.
The timescale for safety-related changes is often strictly regulated, leaving little room for negotiations.
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 timeframes. 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, which may operate at arms’ length to the main business.
Triggers for labelling changes can come at different points in the drug ecosystem, too. 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.
Portals are not a panacea
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 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 labelling 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.
Achieving complete end-to-end traceability and control is something life sciences organisations are increasingly attuned to.
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.
Certainly, the bolder and more innovative firms become in their quest to expand their markets and portfolios, and the more they become subject to intensifying regulatory/public safety criteria, the more meticulous and efficient they must be in their monitoring and process controls.
Looking and planning ahead
To keep pace with regulators’ growing safety controls, companies must upgrade their approach to labelling management with some urgency now. Many already have three to five-year change programmes underway, with the aim of establishing holistic, transparent and collaborative global label management environments.
These comprehensive plans are encouraging, paving the way for a definitive source of labelling 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.
These comprehensive plans are encouraging, paving the way for a definitive source of labelling truth.
Ideally, plans should be cross-functional. 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 programmes should factor in everything from how country-specific requirements are captured, the knock-on effect of changes across the global organisation, 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.
It’s still early days, but there is much to gain by being thorough.
About the author
Agnes is a senior life sciences consultant at AMPLEXOR with a remit that includes the provision of business process and data management expertise in the areas of regulatory information management, document management, and submission management. Prior to joining AMPLEXOR, Agnes worked at Merck in its Global Regulatory and Quality Assurance department. Agnes received her master’s degree in Information Management from the University of Koblenz-Landau.