Digitization. The way forward for regulatory labelling

Although the implementation of innovative technology can be a catalyst for success across industries, the life sciences industry has traditionally approached change management with caution. But a reluctance to fully embrace new technologies can limit an industry’s ability to streamline processes, improve operational efficiency, and reduce overall costs, ultimately slowing down time to market. For these reasons, within the global pharmaceutical regulatory system, change is not merely a luxury but a necessity.

 

In the following article, we focus on the European Medicines Agency (EMA) as a prime example, shedding light on the regulatory challenges the global pharmaceutical industry faces. It is important to acknowledge that these challenges are representative of the broader pharmaceutical industry operating on a global scale.

The EMA sets the clock for CHMP Opinion at 210* days (as it currently stands for standard Centralised Procedures) to review applications of medicines (a process known as the Marketing Authorisation Application, or MAA). This timeline holds true for both initial and subsequent applications (known as Variations). However, this clock will temporarily pause while pharmaceutical companies prepare responses to satisfy any/all EMA questions. As a result, the review process can be much longer, frustrating applicants eager to go to market. This is especially problematic when seeking approval for drugs aimed to address life-threatening or serious illnesses. Although there are expedited review pathways (such as PRIME and the Accelerated Assessment options), applicants must prove that the drug meets an unmet medical need and/or addresses a "major public health interest" among other requirements. But the main challenge is the antiquated method of submission, regardless of the pathway.

 

Consider each of the following technological advancements the EMA has introduced since the advent of the internet:

Arguably, the EMA has come a long way, replacing paper-based submissions with several electronic submission pathways. However, each of the above electronic portals can only facilitate stand-alone submission procedures, and therefore, the overall process remains cumbersome and slow.

 

The drug approval process is extremely data intensive. Not only is the EMA charged with evaluating colossal amounts of sensitive information that impacts the pharmaceutical industry's profitability and the health and wellbeing of the greater patient population, but the regulatory labelling process alone must include all 24 official languages of the EU. To enhance and expedite this process, the key doesn't necessarily lie in introducing another independent electronic portal. The answer lies in implementing an integrated electronic submission system that can effectively handle all the necessary labelling content in each official language of the EU. RWS is diligently working on a solution that aims to provide the answer to this demand.

RWS is much more than a specialized translation provider. We are specialists in content authoring, content management, content creation, translation/localization, and publication with an integrated, full suite of innovative technology solutions to streamline the regulatory labelling process. While any number of translation companies can offer "one" tool or "one" technology solution to satisfy a part of this complex submission process, RWS has "all" the puzzle pieces that we bring together to create an integrated solution benefitting pharmaceutical companies, the EMA, and the medical community.

 

Given their lack of language expertise, technology companies, in general, may struggle to grasp the full scope of these regulatory challenges. Likewise, while other translation companies can claim quick turnaround times and accurate translations, they don't truly understand the intricacies of the EMA's pharmaceutical compliance, review, and change management ecosystem—but RWS does. Our technology solution goes well beyond translation to include content authoring, change management (including the capturing and tracking of labelling changes), maintenance of accurate product information (including the reuse of regulation-approved translations), and the management of signing-off and approval processes.

We all know that the regulatory process is slow to change but RWS is making change happen.

 

Beyond our advanced translation technologies and cutting-edge CAT tools, we've been developing specialized software to integrate and streamline the entire regulatory labelling process. We are preparing to come to market with a one-solution-fits-all from start to finish.

 

We are eagerly anticipating the release of our upcoming software solution, as it holds significant promise. The unique advantage lies in its seamless integration of digitization and automation processes, discreetly operating in the background while maintaining a sense of familiarity. This aspect is particularly valuable for rapporteurs who often exhibit a preference for conventional word processing software like Word. Our advanced software retains the user-friendly interface of Word while incorporating robust features that enhance efficiency and productivity. Therefore, individuals proficient in writing, editing, and creating within Word will seamlessly transition to our software.

RWS has decades of experience working within the life sciences industry, supporting our pharmaceutical clients with compliance, review, and change management processes. Adhering strictly to the Fast Healthcare Interoperability Resources (FHIR) standards, we serve 18 of the 20 top pharmaceutical companies worldwide. RWS has the investment, power, knowledge, experience, and know-how to fill the current application submission gaps while also planning for the future. In short, we lower the cost of the translation workload while expediting the regulatory labelling submission process.

 

The regulatory labelling process is on the brink of transformation, driven by the growing demand for faster access to information and expedited drug approvals. This shift towards digitization is inevitable for most—if not all—major pharmaceutical companies. For this reason, health authorities (including the EMA) have expressed their interest in exploring digital solutions such as electronic Product Information (ePI). While a change in the submission process may take time to materialize, RWS is proactively developing a solution that brings efficiency, cost savings, and reduced rework to the table, complementing the benefits of a streamlined submission process. Once the industry embraces an integrated digitization process, the true potential of our software is sure to lead to exponential advantages.