The ongoing efforts to distribute the COVID-19 vaccine across the globe have shed light on the globalization of pharma products and the varying regulatory standards that must be met in different countries before drugs and vaccines can be approved and delivered to patients. Label change requirements can be brought on by a range of factors, from new safety information to a technical change or spelling error, but they can cause significant bottlenecks for vaccine distribution in countries around the world. For example, Pfizer’s COVID vaccine recently encountered a labeling challenge of its own when vaccine vials were found to contain six doses rather than five. This changed the way states and countries were counting promised and highly coveted vaccine doses.
Outside of the pandemic, over the years, more than 150 regulatory organizations across the globe have enacted increasingly strict mandates on pharmaceutical operations, clinical research, and sales and distribution.
The U.S. Food and Drug Administration (FDA) alone has released more than 2,000 new or modified regulations since 1998, amounting to an average of almost two new regulations per week. Consequently, many pharmaceutical companies have become acutely aware of the inefficiencies in their traditional product labeling strategies and are exploring label management systems (LMS) to automate their product labeling and label updates.
Automated Versus Manual Labeling Challenges
Label management processes have historically been highly manual tasks that take considerable time to execute with every label change. What’s more, the frequency of these changes has been increasing substantially over the years. Life sciences organizations are responsible for compliance with varying regulatory standards that change depending on the region and product type. The responsibility of regulatory compliance remains just as stringent when companies are subjected to unexpected situations that require rapid labeling changes.
Life sciences product labels change depending on factors including safety and efficacy, to simple visual changes to label graphics and presentation. When drugs and medical devices are marketed in different countries, organizations must ensure that any labeling changes comply with the regulatory standards of that region. Non-compliance results in penalties ranging from fines to loss of market authorization and risks the safety of patients and product users.
Due to the number and variance of regulations from country to country, pharmaceutical companies can no longer afford to spend resources and time dealing with fragmented information and disparate processes that are commonly caused because of manual labeling. This is evidenced by the 53 percent of global life sciences CEOs who now consider industry regulations as a top disruptive business trend (which needs to be addressed).
Unfortunately, the industry is often weighed down by legacy systems and processes. While new emerging companies can adopt automated solutions at the ground level, larger legacy companies must retroactively redesign their labeling and surrounding business processes. With this in mind, pharmaceutical leaders must take a calculated journey towards automating labeling by adopting LMS to better comply with regulations.
Many life sciences organizations are currently undergoing digital transformation efforts. So, folding labeling automation into existing digital transformation initiatives will help to reduce the burden of deploying labeling solutions across their enterprise.
The Benefits of Labeling Intelligence in Pharma Industry
While automated labeling technology is still relatively new, current automated solutions for life sciences labeling can offer significant benefits and set companies on the right path to stay ahead of the curb as this technology rapidly evolves. Automating labeling processes today optimizes time, resources, risk mitigation, and competitive advantages.
Organizations that rely on manual power alone for regulatory compliance cannot possibly keep up with the most two regulatory changes per week issued by the FDA on top of the plethora of other health agencies worldwide, while simultaneously adjusting product labels around the world to maintain country-level compliance. Automating the rote, repeatable steps in product labeling processes reduces the risk and administrative burden associated with label changes.
Historically, the manual tasks for regulatory compliance with which labeling updates are associated have been viewed by life sciences organizations as cost centers. Automating the standard tasks in labeling efforts will not only reduce the associated costs but also free up the time of employees assigned to manage regulatory compliance, enabling them to focus on things that help to provide more of market advantage and improve revenue-generating operations.
Thanks to automation and advanced labeling intelligence, labelers can proactively react to regulatory changes and glean insights that will enable them to rapidly comply with shifting regulations. In addition, labeling intelligence acts as a failsafe to prevent inaccurate product labeling from negatively impacting patient safety. This pushes the industry further towards placing the patient at the center of their business practices by creating a new level of transparency between the organization and its customers.
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The pandemic, and the demand it created for rapid delivery of various treatments and vaccines around the world, have highlighted the shortcomings of current manual regulatory compliance processes—not the least of which is labeling. Companies that adopt innovative technology solutions to better manage regulatory and business processes will be positioned to continue their growth following the pandemic, despite any other unexpected black swan events that may be in store for the future.
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