The market scenario of drug and device labeling is evolving rapidly and is evident with the FDA’s mandate PLR, PLLR drug labeling guidance, 21 CFR PART 801 general device labeling guidance. EU also maintains drug labeling of Quality Review Document (QRD) on SmPC, labeling and package leaflet and EU has implemented the Medical Device Regulation (MDR) on device labeling guidance, and Unique Device Identification (UDI) system coming to the surface in EU and US markets. Labeling trends are changing and in this paper, we will be discussing these emerging trends. We will be focusing on content management issues, developments in artwork, impacts of labeling, types of labeling tools in demand, and digitization in labeling. These trends will offer you a better insight into the future and would often help you in understanding your current position.
STRUGGLE OF MANAGING LABELING CONTENT
In the current scenario, labeling can be in various forms like that of physical and digital as well. Controlling the content becomes difficult as it comes from several sources. All these contents do undergo safety changes thereby making the task of tracking even more difficult. Generally, during periodic review or post-marketing, clinical safety-related information changes. Manufacturers/ Sponsors try to modify the labels according to the prior approval supplement (PAS), post-marketing surveillance (PMS) details, changes being effected (CBE) and even annual reports before submitting it to the regulatory authorities. This would allow the sponsors to update the labels independently following the latest safety information and with immediate action. Organizations look forward to collaboration so that all the data is available at the source thus enabling them to keep a check on the labeling content. To ensure this control, e-labeling has already entered the market and with time it is taking up much of the space in the life science industry. The spread of e-labels has been so extensive just because a maximum portion of the information can be delivered through such e-labels and e-labels allow for an easy updating of information than the printed labels.
ASSEMBLING OF ARTWORK AND LABELING FOR ENTERPRISES
Labeling is reaching new heights over the years and with this comes new complications. The enterprises are trying to manage product labeling and artwork at the same time and maintain end to end life cycle on product labeling. Previously when these were being handled by two different processes, maintaining a connection was becoming difficult. So, the manufacturing companies are trying to streamline the entire process starting from the creation of the labeling document, artwork labels, and even the review process ending with the approval. There is a rise in the demand for a central repository to derive everything from one end.
DEMAND FOR WEB-BASED LABELING TOOL
Most organizations are looking forward to labeling tools that are either SaaS (Software as a Service) based or cloud-based. Automation is the key to achieve error-free results in labeling, raising compliance. The prime reason behind this shift in trend is the thought that the labeling process would get simplified through this. Other than this, accessing the global market through expansion and even cost reduction too can be easily achieved. It is due to the increase in productivity backed by the predictability that leads to the rise in the demand for automation tools.
MOVING AHEAD TOWARDS DIGITIZATION
Digitization of labeling has been taking place over the years. The trend is still active to make detailed product information available to the consumer and to all those present in the supply chain. With the optimum use of software, labels and artworks get digitized making the process more realistic. The labeling tools that are used are generally done as per the standards so that they abide by the regulatory norms. The implementation of the bar code on the labels helps the companies to include multiple details that might be required in the supply chain. Without digitization, printing and re-printing labels were leading organizations to incur huge losses. While now, the organizations can avail the e-labels, easing the burden of continuous modifications and even allowing achieving cost efficiency.