However much progress life sciences companies have made in bringing their regulatory information under control, labelling management continues to overshadow these accomplishments. Too often labelling is disconnected from other systems, forcing heavy reliance on manual processes and checks which in turn can cause hold-ups and create an undesirable source of risk, especially across country borders. Agnes Cwienczek delves deeper into the issues and potential remedies
There is no question, the global labelling management burden in life sciences has soared. Each time a drug’s 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 cannot, they face potential delays to market or even failing to maintain product registrations, with an impact on sales, revenues and reputation.
Since all of these market conditions will intensify rather than diminish, finding a solution sooner rather than later has become a priority. Managing labelling across multiple markets internationally is challenging enough but, as the frequency and complexity of changes increases, companies must find a new approach. The timescale for safety-related changes is often strictly regulated, so if firms lack visibility across their global operations, or effective controls so that they are unable to perform a rapid and comprehensive impact assessment for each new requirement, the implications could be very serious.
The rise in labelling management complexity has much to do with the way content interdependencies are managed – ie 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 at a reference-country and dependent-country level.
Historically, this has been managed using a combination of purpose-specific systems and manual processes. Label status tracking has happened in Excel spreadsheets or home-grown systems, and content has been updated on a country-by-country basis using dedicated, often stand-alone 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.
Maintaining control in a volatile environment
What all of this boils down to, ultimately, is an inability to efficiently map country/label interdependencies so that changes can be rolled out promptly and reliably wherever new requirements apply.
The ripple effects of required 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.
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 time frames. 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.
Causes of 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.
The limitations of data-exchange portals
One approach life science 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.
Moreover, 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.
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.
Broader digital ambitions
In the meantime, regulatory agencies are developing a taste and flair for digitised information handling, and the likelihood is that safety-related traceability will become increasingly important over time, with an expectation that the industry will cooperate with more structured and detailed data.
To keep pace with such developments, companies must update their approach to and means of managing labelling across a product’s life cycle. Many are responding already, with three- to five-year change programmes designed to create more joined-up, transparent and collaborative label management environments – which transcend country, departmental and even organisational boundaries.
Such plans pave the way for a definitive source of labelling truth, in the form of central master data – from which everything else flows. They also embrace intelligent workflows – 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.
The most forward-thinking plans are cross-functional. They 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. The investment programmes are holistic in approach, too. They look at everything from how country-specific requirements are captured, the knock-on effect of changes across the global organisation, the interplay of different operational functions, and the potential for content re-use once approved ‘fragments’ or blocks of text/icons/images are filed in the master repository.
This will stand these firms in good stead as the pace of industry transformation continues to accelerate. It’s still early days, but there is much to gain by being thorough. First steps include determining where all the sources of data are and how best to connect them. With the right building blocks in place, firms will be well placed to realise their goals.
Agnes Cwienczek is a senior life sciences consultant at AMPLEXOR