Localization Lessons from EMA and FDA Submission Failures

Global regulatory agencies such as the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA) each maintain distinct language, formatting, and documentation requirements for life sciences submissions. While the industry continues to advance in standardizing processes, translation and localization errors remain a persistent cause of delays, rejections, and post-market compliance issues.

Accurate translation is not a peripheral task but a critical component of regulatory strategy. Errors in patient labeling, clinical trial documentation, or Instructions for Use (IFUs) can lead to agency queries, require resubmission, or in some cases, halt product approvals altogether. These risks are amplified when translation workflows lack domain-specific linguistic validation, in-country review, or alignment with the latest regulatory guidelines.

This article examines real-world examples where translation gaps have disrupted EMA and FDA approvals. It also outlines proven strategies to mitigate these issues, including terminology control, process automation, and expert linguistic QA. For life sciences companies operating across markets, avoiding localization failures is essential to achieving faster approvals and maintaining regulatory compliance.

Common Translation-Related Pitfalls in EMA and FDA Submissions

Despite advancements in global submission workflows, translation errors remain a significant barrier to timely product approvals. Below are the most common language-related issues encountered during EMA and FDA submissions.

Inaccurate or Incomplete Terminology

Precise terminology is essential in regulatory submissions. Confusion often arises between scientific, medical, and regulatory language. Translators unfamiliar with agency-specific lexicons may use clinically accurate terms that do not align with regulatory expectations.

Case example: A global pharmaceutical company submitted a translated dossier using inconsistent drug classification labels across modules. The EMA flagged the submission for clarification, delaying approval by several months.

Lack of Country-Specific Localization

Each regulatory agency requires distinct document structures and language conventions. The EMA mandates use of the QRD template and expects translations tailored to EU member state requirements. The FDA, on the other hand, emphasizes plain language readability and U.S. patient comprehension standards.

Case example: A U.S.-based manufacturer reused FDA-aligned patient labeling in its EU submission. The content failed to meet QRD format expectations, resulting in a request for resubmission and updated translations for multiple markets.

Mistranslations in Patient-Facing Content

Patient materials such as Informed Consent Forms (ICFs) and Instructions for Use (IFUs) must balance medical accuracy with cultural and linguistic accessibility. Misinterpretation or literal translation of key safety information can lead to regulatory scrutiny and potential legal consequences.

Case example: A clinical trial’s ICF in Spanish contained phrasing that implied guaranteed treatment outcomes. The FDA rejected the submission until the language was revised and reviewed by a certified medical translator.

Real-World Examples of Submission Delays Due to Language Issues

Translation and localization errors continue to cause regulatory setbacks across global markets. The following anonymized examples, based on public regulatory reports and industry experience, highlight the high cost of language-related issues in EMA and FDA submissions.

Example 1: Delayed EMA Approval for a Rare Disease Drug Due to IFU Translation Issues

A biotech company submitted a Marketing Authorization Application (MAA) for a rare disease therapy targeting multiple EU countries. The Instructions for Use (IFU) were translated without applying the required EMA QRD template or validating the localized terminology through in-country review. National regulators flagged inconsistent phrasing related to dosage administration, resulting in a regulatory clock stop and a three-month delay in approval. The company was required to revise and revalidate the translated IFU for all affected markets, underscoring the need for professional IFU translation services that meet EMA requirements.

Example 2: FDA Clinical Trial Rejection Due to Inaccurate ICF Localization

During a multicenter clinical trial, a sponsor submitted Spanish-language Informed Consent Forms (ICFs) for sites in the United States. The translated documents contained literal phrasing that conflicted with FDA readability guidelines and omitted essential risk disclosure language. The FDA rejected the ICFs as non-compliant, forcing the trial sponsor to halt patient enrollment until revised versions were submitted and approved. The delay added significant cost and pushed trial timelines back by over two months.

Example 3: Market Withdrawal After Complaints About Unclear Patient Instructions

A medical device manufacturer launched a Class II device in the EU. Soon after market entry, end users in France and Germany reported difficulty understanding key operating instructions. An investigation revealed that the localized IFUs were machine translated and had not undergone professional linguistic validation or in-market review. Regulatory authorities classified the issue as a risk to patient safety, prompting the company to voluntarily withdraw the product from several markets and resubmit corrected documentation, delaying further commercial rollout.

These examples underscore the regulatory and financial risks of inadequate translation workflows. High-quality localization, validated by subject-matter experts and aligned with agency-specific requirements, is essential to avoiding similar setbacks in global submissions.

Root Causes of Localization Failures in Regulatory Submissions

Many language-related issues in global submissions originate from systemic process gaps rather than isolated translation mistakes. Below are the most common root causes that lead to regulatory delays and compliance risks.

Over-Reliance on Non-Specialist Translators

Generalist translators often lack familiarity with regulatory terminology, agency-specific templates, and therapeutic area nuances. This can result in inaccurate or non-compliant language, especially in clinical and labeling documentation.

Lack of Centralized Terminology Management

Without a controlled and centralized terminology database, translation teams struggle to maintain consistency across modules, product families, or markets. Inconsistent use of terms such as adverse events, dosage forms, and safety instructions frequently triggers regulatory queries.

Fragmented Review Processes Between Local Affiliates and Headquarters

When regional teams operate independently from the global regulatory function, localized content may diverge from approved core materials. Misalignment between affiliates and HQ leads to duplicated efforts, rework, and inconsistencies across submissions.

Last-Minute Translation Work Without Linguistic Validation

Translation is often treated as a downstream task, resulting in compressed timelines and reduced quality assurance. Skipping early-stage linguistic input and in-context review increases the risk of avoidable errors in submission-critical content.

Absence of Linguistically Aware QA Checks

Many organizations rely solely on scientific or regulatory reviewers who may overlook linguistic flaws. Without linguistically trained QA specialists, issues like incorrect syntax, unclear phrasing, or formatting errors can slip through and compromise submission quality.

Lack of Technology Integration

Failure to leverage modern translation technologies, such as terminology management systems, translation memory, and automated QA tools, limits scalability and increases error rates. Technology-enabled workflows help enforce consistency, flag discrepancies early, and reduce turnaround time across multilingual submissions.

Identifying and addressing these root causes is key to building a sustainable, compliant localization process that meets global regulatory expectations and supports faster product approvals.

How to Avoid These Mistakes: Best Practices for Regulatory Localization

Avoiding translation-related submission delays requires more than linguistic accuracy. It involves implementing structured localization workflows that combine regulatory knowledge, linguistic expertise, and the right technology. The following best practices help life sciences companies achieve faster approvals and sustained global compliance.

Engage Qualified Life Sciences Linguists

Regulatory content should be translated by professional native linguists with proven subject-matter expertise in life sciences. Translators must understand medical and regulatory terminology, as well as the submission expectations of agencies such as the EMA and FDA. This ensures that documentation not only meets linguistic standards but also aligns with regulatory translation services Sesen provides for global submissions.

Implement a Robust Review Workflow

A successful localization process integrates linguistic quality assurance with regulatory validation. Collaborating closely with regulatory affairs teams and language service providers allows for early identification of compliance risks. This collaboration also ensures alignment between source content and localized versions, reducing the need for corrective rework during agency reviews.

Use Controlled Terminology and Style Guides

Centralized glossaries and style guides are essential for maintaining consistency across all submission materials. Controlled terminology supports clear communication of scientific and regulatory concepts while reducing reviewer confusion. Style guides also help harmonize branding and tone, particularly in patient-facing documentation such as IFUs and ICFs.

Leverage Translation Technology Thoughtfully

Translation technologies can improve quality and efficiency when applied correctly. AI tools support faster glossary extraction and consistency checks across large volumes of multilingual content. Sesen applies AI-enabled clinical trial translation to improve turnaround time without compromising regulatory accuracy. However, human oversight remains essential to review context and ensure the final output is compliant and fit for submission.

By combining expert linguists, structured processes, and appropriate technology, life sciences companies can significantly reduce the risk of language-related submission failures and gain a competitive edge in regulatory approval timelines.

Sesen’s Approach to Regulatory Translation Quality

At Sesen, we recognize that regulatory translation is a high-stakes task that directly impacts product approval timelines, market access, and patient safety. Our quality-focused approach combines industry certifications, specialized linguists, and collaborative workflows to deliver submission-ready translations that meet global regulatory standards.

ISO 17100 and ISO 13485:2016 Certification

Sesen’s translation processes are certified under ISO 17100, which governs quality standards for translation services, and ISO 13485:2016, which applies to quality management systems for medical devices. These certifications reflect our commitment to delivering consistent, traceable, and compliant translations across all therapeutic areas.

Dedicated Linguists Trained in Regulatory Affairs

Our translators are native professionals with expertise in life sciences and formal training in regulatory frameworks. They are familiar with EMA QRD templates, FDA readability guidelines, and local authority expectations in multilingual markets. This specialization ensures accurate, compliant translation of clinical, labeling, and manufacturing documentation.

In-Context QA for Labeling and Patient-Facing Content

We conduct in-context linguistic QA to ensure that Instructions for Use (IFUs), Informed Consent Forms (ICFs), and product labels are not only translated correctly but also clear, culturally appropriate, and aligned with the layout and structure of the final materials. This helps reduce agency queries and supports faster regulatory review.

Collaborative Model with Client RA Teams and In-Country Reviewers

Sesen works closely with client regulatory affairs teams and local reviewers to align on terminology, content priorities, and submission timelines. Our workflow integrates feedback loops and real-time communication to streamline approvals and ensure consistency across global dossiers.

This proven methodology allows Sesen to deliver high-quality, audit-ready translations that support timely approvals with the EMA, FDA, and other regulatory authorities worldwide.

What Regulatory Agencies Expect in Localized Submissions

Regulatory authorities are placing increased emphasis on the quality, clarity, and compliance of translated materials submitted as part of drug, biologic, and medical device approvals. Submissions that fail to meet agency-specific language standards face delays, additional queries, or outright rejection. Understanding what regulators expect is critical to avoiding these risks.

EMA Expectations for Linguistic Clarity and Local Adaptation

The European Medicines Agency (EMA) requires that all product information, including the Summary of Product Characteristics (SmPC), patient leaflets, and labeling, be translated using the Quality Review of Documents (QRD) templates. These templates are structured to ensure linguistic clarity and harmonization across EU member states. National competent authorities also review localized content for accuracy, fluency, and country-specific conventions. Submissions must reflect both regulatory terminology and localized phrasing suitable for healthcare providers and patients in each market.

FDA Guidance on Readability, Plain Language, and Cultural Suitability

The U.S. Food and Drug Administration (FDA) emphasizes plain language and cultural appropriateness in patient-facing content. Translations of Informed Consent Forms (ICFs), Medication Guides, and risk communication materials must meet FDA readability standards, often at a 6th to 8th grade reading level. Translated documents should reflect U.S. English equivalents and cultural norms to ensure patient understanding and informed decision-making. Inconsistent or overly technical language may lead to rejection or requests for revision.

Increasing Scrutiny on Translations for Risk Communications and Labeling

Global regulators are placing greater scrutiny on the accuracy of translated risk-related content, particularly in labeling, IFUs, and safety alerts. Any ambiguity in localized messaging related to dosage, contraindications, or adverse events may be flagged as a patient safety issue. Agencies now expect companies to demonstrate that translated materials are reviewed, validated, and consistent across markets and platforms.

Importance of Traceability and Audit Trails in Multilingual Documentation

Regulatory bodies increasingly require documentation of translation workflows, reviewer comments, version control, and approval history. Full traceability is expected for multilingual documents, especially those related to clinical trials, regulatory labeling, and safety communications. Clear audit trails support regulatory inspections and help demonstrate compliance with quality system requirements.

By aligning with these expectations, companies can reduce the likelihood of delays and strengthen their position in global regulatory review processes.

Final Takeaway: Language Quality Is a Regulatory Risk Factor

In the context of global regulatory submissions, language quality is not a secondary concern. It is a critical factor that directly affects approval timelines, compliance outcomes, and patient safety. Regulatory authorities treat translation errors with the same seriousness as data inconsistencies or procedural gaps.

Poorly localized content can delay product approvals, trigger agency queries, and introduce safety risks when patients or healthcare providers misinterpret key instructions. These issues are often preventable through the use of trained linguists, validated processes, and structured quality control.

Investing in high-quality localization from the outset is more efficient and cost-effective than addressing agency feedback or performing post-submission corrections. A proactive approach reduces rework, mitigates risk, and accelerates time to market.

At Sesen, we help life sciences companies build scalable, compliant localization workflows that align with EMA, FDA, and other global regulatory requirements. Our specialized team, ISO-certified processes, and collaborative model enable clients to achieve regulatory success in multiple markets with confidence.

FAQs

What’s the difference between regulatory translation and standard translation?

Regulatory translation involves highly specialized content intended for review by health authorities such as the FDA, EMA, PMDA, and NMPA. These documents must adhere to strict formatting, terminology, and linguistic clarity standards that differ from general or commercial translation. Regulatory translations often include modules of the Common Technical Document (CTD), labeling, safety communications, and patient materials, all of which require subject-matter expertise and compliance with agency guidelines.

How do regulatory bodies evaluate translated documents?

Agencies assess translated materials based on accuracy, clarity, terminology consistency, and adherence to local regulatory templates. For example, the EMA uses the QRD template and evaluates the quality of translations across all EU languages. The FDA prioritizes readability and cultural suitability in patient-facing content. Regulatory bodies may request revisions, issue clarification letters, or pause review timelines if translated content is inconsistent or unclear.

What languages are most prone to review issues in global submissions?

Languages that require significant localization due to grammatical complexity, regulatory nuance, or cultural differences tend to pose greater challenges. These include Japanese, Korean, Simplified Chinese, and certain EU languages such as Hungarian, Finnish, and Polish. Inaccuracies in these languages are more likely to be flagged by local authorities during review, especially for patient labeling and Instructions for Use.

Can Sesen support simultaneous FDA and EMA submission translations?

Yes. Sesen supports parallel regulatory submission workflows for FDA and EMA by applying region-specific templates, terminology, and QA protocols. We coordinate closely with client regulatory teams to ensure alignment between U.S. and EU dossiers, minimizing duplication of effort while meeting both agencies’ distinct requirements.

Does Sesen offer linguistic validation and back translation services?

Yes. Sesen provides full linguistic validation for patient-facing content, including cognitive debriefing where required. We also offer back translation and reconciliation services for materials such as Informed Consent Forms, enabling clients to identify meaning shifts before submission and ensure regulatory compliance.

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