GHP / Q4 2018 17 , Labelling’ is a broad termthat covers a number of elements, such as control and package labels, directions for use, andmaintenancemanuals. It’s also not limited to print and encompasses electronicmedia presented via amix of user devices. Labelling, Compliance, and Its Ever-Changing Environment: How Can the Pharmaceutical Industry Keep Up? With the evolving pharmaceutical market, the industry has had to shift and adapt to the changing times. There’s a need, now more than ever, to balance complex regulations, rising consumer demand and shifting market realities. And due to the uncertainty surrounding Brexit, potential changes in regulations will increase organisations need to stay agile to achieve compliance. Regulation is of paramount importance and a challenge to manufacturers every day. Therefore, processes need to be adapted to meet changing production demands of speed, safety and flexibility while still continuing to comply with regulations. So, how can the industry overcome some of the biggest challenges it faces, embracing new technologies in order to empower workforces and allow the industry to move forward? Relationships In line with this, the relationship between document-centric regulatory environments, content centric labelling and artwork processes will be of paramount importance. Small but problematic details can lead to significant inaccuracies in both packaging and labelling. This therefore requires content alignment, where approval and review processes need to be visible and auditable to check accuracy of spelling, artwork, graphics, regulatory content and barcodes at every stage of production. Remaining flexible and agile Maintaining compliance will comprise of a connected and agile process between print and electronic labelling. To bridge the gap between consumer packaging groups and converters, the pharma industry will require an evolution of traditional manufacturing infrastructures. The obvious and ultimate solution is electronic packaging and smart labels to enhance the consumer experience and strengthen brand loyalty. New smart devices will inevitably become the new normal and manufacturers s will then search for new functionalities to continuously achieve the best possible packaging and labelling. Simplify content collation Making it easier to capture multilingual labelling and embracing linguistic minorities will better position manufacturers to exploit growth in emerging markets. Tailoring content collation to meet localised regulatory and product labelling requirements through expanded use of business logic will lead to less errors and lower the risk of non-compliance. Digital Labelling Digital labels can also help solve the issue of adapting and are quicker and easier to update compared to print, as well as making it easier to present content in a coherent and attractive format. This will aid patient transparency and see manufacturers more easily adapting to localised language needs leading to better informed patients and improved outcomes. Smart packaging Smart packaging will empower manufacturers to rapidly make changes to label content without enduring the costs associated with reprinting and repackaging. Smart Packaging will enable manufactures to be more responsive and adaptable, without facing the normal constraints imposed by physical printed labels. With this more dynamic approach, patients could have instant access to all information in the language of their choice and as we move closer to patient-centric treatments we could envisage tailored personalised labelling becoming more prevalent.