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As regulatory submissions become increasingly global, life sciences organizations are turning to Artificial Intelligence (AI) to manage the growing volume and complexity of regulatory documentation translations. While AI can support speed, scalability, and consistency, this should not affect the accuracy of the writing, particularly in highly regulated environments where patient safety and compliance are at stake.

AI should therefore not be viewed as a replacement for experienced medical translators or regulatory subject matter experts. Instead, it should be used to augment a human expert’s work by automating repetitive tasks, enforcing terminology consistency, and identifying potential compliance risks early in the translation process.

Why Accurate Translation Is Critical for Regulatory Submissions

When life sciences teams submit to regulatory authorities from different regions, they must provide translated documentation to explain the safety, efficacy, and quality of medicinal products. And when these authorities spot inaccurate or inconsistent translation, it could lead to consequences, including:

• Delayed approvals due to additional clarification requests

• Rejection of submissions caused by discrepancies between language versions

• Ethical risks in clinical trials if informed consent is unclear or misleading

• Increased likelihood of findings during inspections or audits

Key Regulatory Bodies and Their Language Requirements

Global regulatory submissions must comply with varying language and documentation requirements set by health authorities in different regions. Some of the current language requirements for the different regulatory bodies across the world include:

• Food and Drug Administration (FDA): All submissions must be in English. Any clinical or regulatory documents originally authored in another language must be accompanied by a certified English translation. However, for materials distributed solely within the Commonwealth of Puerto Rico or in territories where a language other than English is predominant, the predominant local language may be used in place of English.

• European Medicines Agency (EMA): EMA requires content, standard headings, and commonly used statements and terminology for regulatory documents to be in official European Union (EU) languages, as well as Icelandic and Norwegian, and specify the approved format and layout for product information.

• Pharmaceuticals and Medical Devices Agency (PMDA): Full Japanese-language submissions are required, with strict expectations for scientific phrasing and terminology.

• National Medical Products Administration (NMPA): All submissions must be in Simplified Chinese and supported by certified translations of technical specifications, clinical study reports, and related regulatory documentation.

Types of Regulatory Documents That Require Translation

Translation requirements extend across the entire regulatory lifecycle, including:

• Common Technical Document (CTD Modules 1–5)

• Investigator Brochures (IBs) and clinical protocols

• Informed Consent Forms (ICFs)

• Clinical Study Reports (CSRs)

• Development Safety Update Reports (DSURs)

• SmPCs, Patient Information Leaflets (PILs), and labeling components

Each document type carries different levels of regulatory and patient risk, requiring tailored translation and quality control strategies. 

Exploring AI as a Solution for Translating Regulatory Dossiers

To meet the growing need for efficiency in translating regulatory dossiers for submission to health authorities across multiple regions, advanced AI language models can now support regulatory translation.

Unlike general-purpose translation tools, AI platforms purpose-built for regulatory content creation and compliance-driven workflows. With embedded translation capabilities, these platforms significantly reduce manual rework while improving consistency and control. Other capabilities include:

• Automated alignment with approved terminology databases and controlled vocabularies

• Real‑time translation suggestions within authoring tools like Microsoft Word

• Automatic detection of noncompliant phrasing or formatting deviations

• Side‑by‑side bilingual comparison to identify discrepancies quickly

• AI‑driven quality checks for abbreviations, numerical accuracy, and style enforcement

Where AI Delivers the Biggest Impact

AI delivers the greatest value in automated regulatory documentation creation and translation. Some of its benefits include:

• Creating high-volume repetitive documents, such as investigator brochure updates and protocol amendments

• Labeling harmonization across multiple markets

• Ensuring synchronization of document revisions across languages

• Automatic updating of translations when upstream source documents change through RIM integration

Despite these capabilities, AI does not replace human expertise. Human quality control, linguistic validation, and subject matter expert (SME) review remain mandatory. Scientific judgment, regulatory interpretation, and final accountability require human oversight, with AI serving as an enabling technology rather than a replacement.

Best Practices When Using AI for Translating Regulatory Dossiers

For medical writing and regulatory teams, implementing best practices when leveraging AI for translation is essential to ensure accuracy, compliance, and efficiency. Structured workflows, clear governance, and human oversight are critical to maximize AI benefits while mitigating regulatory risk. The following practices outline how to achieve optimal results:

1. Establish a Unified Terminology Governance Framework

A centralized terminology framework ensures consistency across writers, translators, and AI systems. Approved term bases should include MedDRA templates and local regulatory terminology. By integrating these standards into AI-enabled platforms, organizations can actively enforce correct term usage during drafting and translation, reducing discrepancies and ensuring alignment across multiple languages and markets.

2. Use AI‑Enhanced Authoring Platforms Rather Than Standalone Translation Tools

Integrated AI authoring platforms embedded in Microsoft Word and connected to regulatory information management (RIM) systems, such as AuroraPrime, ensure translations remain aligned with source-of-truth documents. Unlike standalone translation tools, these platforms eliminate risks associated with copy-paste workflows, content fragmentation, and inconsistent versioning, helping teams maintain regulatory compliance while improving efficiency.

3. Implement a Human‑in‑the‑Loop QA Workflow

Best practice workflows combine automated AI checks with human expertise to maintain regulatory rigor. Key QA layers include:

• Automated terminology and style checks

• Linguistic validation for patient-facing and clinical content

• Subject matter expert (SME) review and final approval

This human-in-the-loop approach ensures that AI-generated translations are scientifically accurate, compliant, and ready for submission.

4. Build Translation Into Submission Planning (Not After)

Translation should be an integral part of submission planning rather than a post-submission task. Early integration enables parallel drafting in multiple languages and identifies sections suitable for pre-translation. AI can provide alerts when source documents are updated, ensuring that all translations remain synchronized with the latest version and reducing last-minute rework.

5. Train AI Systems on Domain‑Specific Data

AI models achieve higher accuracy when trained on proprietary company glossaries, historical dossiers, and previously approved submissions. General-purpose translation models often fall short when handling complex pharmaceutical or clinical content, making domain-specific training essential to ensure precise terminology, compliance, and submission readiness.

Streamline Translation of Regulatory Dossiers with AuroraPrime RMA

As global regulatory requirements for medical writing submissions continue to become more stringent, AI platform for medical content authoring such as AuroraPrime RMA are becoming essential for regulatory teams. Designed as an AI writing platform for life sciences, AuroraPrime supports regulatory content creation and translation within a single environment.

AuroraPrime integrates directly with Microsoft Word and RIM systems, eliminating silos between authoring, translation, and submission management. Its AI engine enforces terminology consistency, supports multilingual drafting, and ensures every document remains aligned with regulatory requirements.

By unifying authoring and translation workflows, AuroraPrime RMA reduces regulatory risk, improves compliance readiness, and accelerates global submissions. This, in turn, helps global teams meet regulatory expectations with confidence. For additional guidance on AI use cases in life sciences, our team can provide tailored advice on leveraging these platforms to optimize your medical writing processes.