Unique Challenges in Life Sciences Localization 

In the rapidly evolving landscape of global healthcare, life sciences companies are navigating through a sea of regulatory changes that create significant localization challenges. The introduction of new regulations has ushered in a new era of compliance, clinical evaluation, and post-market surveillance. These requirements, captured in the Medical Device Regulation (MDR, EU 2017/745), the In Vitro Diagnostic Regulation (IVDR, EU 2017/746), and the Clinical Trial Regulation (EU 536/2014) set the stage for a series of unique challenges in life sciences localization efforts. 

The MDD to MDR and IVDR Transition: A Tighter Regulatory Grip 

The shift from the Medical Device Directive (MDD) to the more stringent MDR and IVDR marks a significant turning point. The previous MDD framework allowed for some leniency in terms of clinical evaluation and post-market surveillance. However, under the new regulations, there is an intensified focus on rigorous clinical evaluations and enhanced post-market surveillance mechanisms. This shift towards robust regulations mandates a comprehensive overhaul of the data management practices within organizations. Companies must drive transformative changes across all departments to comply. 

The Impact on Localization Goes Beyond Translation 

Companies must closely assess post-market changes, identifying the implications of changes and associated risks. Additionally, they must promptly update content, whether labeling, technical documentation, or quality reporting. Many of these updates require accuracy, consistency, and readability. Executing these translations within exceedingly tight timelines requires a change of approach for many organizations.  

The challenge is not just about managing changes to the source content. Organizations must manage the translations with an equally strategic approach to change management. This dual focus intensifies the complexity of localization efforts. Each piece of content must be compliant, up-to-date, accessible to global audiences, and consistent with other previously released content.  

Leveraging Technology to Meet Regulatory Demands 

The heightened regulatory requirements underscore the need for advanced and integrated technology solutions. Life sciences companies are increasingly turning to technology to streamline the management of regulatory documentation and to ensure compliance. This includes adopting sophisticated Content Management Systems (CMS) that are directly integrated with their LSP’s translation management systems (TMS). The TMS is integrated with downstream systems, including computer assisted translation, AI, machine translation, terminology management, and quality assurance.  

The systems must support the complexities of regulatory submissions and manage vast amounts of data securely and efficiently. We’ll do a deep dive into the use of CMS in a subsequent post. 

Clinical Trial Regulation (CTR) and Its Localization Repercussions 

Regulation EU No 536/2014, pertaining to clinical trials, introduces another layer of complexity. It demands the implementation of plain language summaries for clinical trial results and a more centralized approach to the clinical trials submissions. This regulation requires that submissions across all languages be conducted simultaneously. This mirrors the exigent timelines typical of the drug regulatory submissions process. Such a requirement places immense pressure on localization teams to ensure timely, accurate, and regulatory compliant translations across multiple languages. Many of the same technologies that benefit the medical device industry also enable CTR compliance. 

Navigating Data Security in Localization 

In an increasingly digital world, data security stands out as a paramount concern. This is exacerbated by the increasing use of cloud-based translation memories, machine learning, and generative AI tools for localization tasks. For life sciences companies venturing into the development of localized digital health mobile applications, this concern intensifies. These entities must meticulously navigate the complex landscape of data protection regulations. These include not only GDPR in Europe and HIPAA in the United States but also local data protection laws that vary from country to country.

It is crucial for these companies to implement robust data security measures, ensuring the confidentiality, integrity, and availability of sensitive medical data. This involves deploying end-to-end encryption for data transmission, secure data storage solutions, and rigorous access controls to safeguard health information. Additionally, they must ensure that any third-party services or tools used in the localization process meet these stringent security requirements. By prioritizing these data security essentials, life sciences companies can protect patient information effectively while delivering localized digital health solutions catering to global markets.

CFR Part 11 Compliance in Localization Processes 

Moreover, GXP’s 21 CFR Part 11 adds another layer of regulatory compliance for translation management systems and content management systems. As life sciences companies transition from document based to component based content management, they must ensure that their CMS and TMS remain CFR Part 11 compliant. These requirements extend in part to their LSP’s, who to date, have not broadly been laser focused on GXP compliance. 

The evolving regulatory environment presents a complex array of challenges for life sciences companies, particularly in the realm of localization. As regulations become more stringent, the need for meticulous, culturally sensitive, and regulatory-compliant translations intensifies. To navigate these challenges successfully, life sciences companies must leverage advanced technologies, implement strategic change management practices, and maintain a steadfast focus on data security and regulatory compliance. The path forward demands a multifaceted approach to localization. Life sciences companies need to combine linguistic skills, regulatory knowledge, and technological advancements to achieve the best global outcomes.

#localizationinstitute #lifescienceslocalization #lifesciences #PeakGlobalSolutions #RegulatoryAffairs #MedicalDevice #ClinicalTrials #Consulting #ChangeManagement