CRITICAL ROLE OF LABELLING MANAGEMENT IN REGULATORY AFFAIRS

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Labelling for human healthcare products (i.e. medical devices, medicines, cosmetics, vitamins, and dietary supplements) is a complex, interdisciplinary function that services the corporate and regulator-approved prescribing information, instructions for use and pack information for consumers, patients and healthcare professionals, together with correct advertising and promotion.

Within the biopharmaceutical industry, product labelling is regarded as a science, which services multiple drug products and markets, and needs to accommodate different formulations and dosages. Accurate tracking and harmonisation of labelling information necessary to maintain the safety and efficacy of a drug, is essential for pharmaceutical and consumer health companies.  An effective and robust labelling system should therefore include a defined process, tracking tools and well-trained labelling professionals.  Furthermore, it is logical and thus strongly recommended that the management of reference safety information (RSI) for medicines; that is the expectedness of adverse events in clinical studies, or the “listedness” of adverse events against which post-approval benefit-risk are assessed, should be integrated with the Labelling Function.  The usual active substance-specific vehicle for RSI management is the Company Core Data Sheet (CCDS), which is an internal reference document that outlines the company position on the safety and efficacy of the product.

Despite the categorisation of labelling management as a “science”, many of those working in this sector would claim that it suffers from more than its fair share of pain points!  The fact that regulation cannot keep up with rapidly evolving technologies and IT standards, means that the relatively old-fashioned ways of working persist, and there needs to be a substantial level of human interaction to support the necessary rigor of the job responsibilities.  Despite this, the risks of errors such as those due to duplication, typographical errors, mis-keying, wrong assumptions about versioning, and even miscommunication remain high, and as a result, labelling “science” involves check after check.  On the other hand, regulations, directives and new guidelines that have an impact on product labelling, have a habit of sneaking in over time.  In comparatively recent years for example in the European Community, this has included the Paediatric Regulation (1901/2006), Falsified Medicines Directive (2011/62), a new annex to the guideline on “Excipients in the labelling and package leaflet”, and regular updates in the reference documents and templates supporting the Quality Review of Documents (QRD).  Therefore, as well as being obsessive about the accuracy of the information contained in labelling documents, there is the need to keep on top of the external legislation and guidelines applicable to the company’s products.

Labelling professionals need to co-operate successfully with colleagues in Clinical, Medical Affairs, Legal, Pharmacovigilance, Manufacturing, Supply & Operations, Artwork, Marketing, and Sales, and be anchor person for those in Regulatory Affairs responsible for interacting with the Regulators.  At the very least, they need to be confident subject matter experts, strategic thinkers, adept communicators and influencers, and able planners, who start from the agreed date of submission and work backwards in setting due dates for the milestones required to produce a robust document for the development or introduction of new medicinal products and post authorisation change control.

Final labelling must be commercially viable and fit within the corporate pipeline.  There, of course, needs to be a previously inadequately met medical need for the indication(s) within the targeted patient population, which differentiates from and improves on those of the competition.  It is always prudent to develop a best-case label to fit with the target profile for the product in development but agree a realistic fall-back with project members should the regulators fail to interpret supporting data in as positive a way as hoped.  Post the granting of a first marketing authorisation, the approved labelling text will become the basis for the CCDS, and it will be the role of the company labelling function to ensure compliance in all future markets.  For organisations, which have older product portfolios, it may even be necessary to develop a retrospective CCDS based on the authorised texts of many geographies and the voracity of supporting data.  Many of the stakeholders involved with projects for which labelling is pivotal, must continue to be helped to understand the rules, constraints and importantly opportunities from good practices and strategy.

Post regulatory approval there is the necessity to prepare labels and leaflet mock-ups: and co-ordinate the completion of local country needs including translations (i.e. for EU multi-state procedures) and conversion of product information texts into electronic format, such as for the US, Spain, and UK. These activities continue to draw on planning and co-ordinating skills.  Product information/ labelling undergoes more life-cycle changes than any other component of regulated products. Artwork change control can take several months from Authority approval of the label to full company implementation because of the time to obtain new packing components, and time factoring to reduce the level of write-offs.

Labelling is a key tool in informing the patient and healthcare professional about the medicine.  Indeed, for medicines sold outside of a pharmacy, it is the only proper means to inform patients what the product is and how to use it safely.  Today’s patients want to know more about the medicines that they have been prescribed, or to make informed choices for self-care medication.  Although there is much information about medical products in the public domain, unfortunately, much of it is inaccurate and misleading.  So, there is more onus than ever on the MAH to ensure patients can obtain correct and up-to-date information regarding their medicine, rather than just relying on their doctor or pharmacist.  Hence official information on company medicines websites need to be aligned with the authorised Product Information.

FMD K&L has been building significant experience with helping client companies in the human healthcare sector to build centres of excellence for the operation of their processes to fulfil the practical and regulatory requirements of product labelling and associated reference safety information (RSI).  So much so in fact, that we now consider ourselves to be experts in the best way to provide cost-effective management of the challenging logistics of this multi-disciplinary business-critical field, in which the demands of speed and efficiency cannot be compromised.  This is despite dealing with the absolute rigours of regulation, document format, life-cycle management, and the accuracy of labelling content and its comprehension. K&L provides well-trained professionals, who can apply and develop good processes and tools to maintain, track and harmonise company labelling and help companies comply with regulatory requirements and maintain the safety and efficacy of their portfolios of human healthcare products.