Translating for FDA, EMA, PMDA, and NMPA: Best Practices for Global Regulatory Submissions

Globalization has transformed the life sciences industry, with pharmaceutical, biotechnology, and medical device companies increasingly seeking simultaneous regulatory approvals across multiple regions. To support these global submissions, accurate and compliant translation of regulatory documents has become a critical component of the approval process.

Language precision is essential for ensuring that health authorities clearly understand product data, clinical trial protocols, safety profiles, and labeling content. Inaccurate translations can lead to costly delays, rejected submissions, or risks to patient safety. Regulatory agencies such as the FDA in the United States, EMA in the European Union, PMDA in Japan, and NMPA in China each have specific language, formatting, and submission requirements that must be met to achieve market authorization.

This article outlines best practices and translation strategies for preparing multilingual regulatory documentation that meets the technical and linguistic expectations of these agencies. It also examines common pitfalls, document types that require translation, and the importance of using professional native translators with regulatory expertise.

Why Accurate Translation Is Critical for Regulatory Submissions

Accurate translation plays a central role in global regulatory submissions by ensuring that documentation submitted to health authorities is linguistically and technically precise. From clinical trial protocols and informed consent forms to product labels and safety updates, translated content must clearly convey critical information to regulators, investigators, and patients in each target market.

Errors or ambiguities in translation can lead to serious regulatory consequences, including delayed approvals, rejections of marketing applications, audit findings, and noncompliance with local laws. Health authorities such as the FDA, EMA, PMDA, and NMPA expect that all documentation reflects the same scientific rigor and clarity as the original source language.

Translation also directly supports Good Submission Practice (GSubP), which emphasizes the importance of consistency, traceability, and quality throughout the regulatory process. In parallel, Good Translation Practice (GTP) promotes the use of qualified linguistic resources, validated workflows, and terminology control to meet regulatory expectations. By following these principles, companies reduce submission risk and accelerate global market access.

Key Regulatory Bodies and Their Language Requirements

Each regulatory authority has distinct linguistic and formatting expectations that must be met for successful product registration. Understanding these requirements is essential for preparing compliant, high-quality translations that facilitate approval.

FDA (United States)

The U.S. Food and Drug Administration requires all submission documents to be in English. While formal regulatory dossiers such as CTD modules must be submitted in English, multilingual translation becomes critical in clinical trials conducted outside English-speaking regions.

Key documents requiring translation include informed consent forms (ICFs), patient-facing materials, and product labeling for diverse populations. Translations must be clear, culturally appropriate, and consistent with FDA standards to support subject protection and ethical compliance.

The FDA may also request certified translations and signed translation affidavits to validate the accuracy and qualifications of the linguistic resources used.

EMA (European Medicines Agency)

The EMA oversees centralized submissions within the European Union and requires documentation in multiple EU languages. While the core dossier is typically submitted in English, labeling elements such as the Summary of Product Characteristics (SmPC), Patient Leaflet (PL), and packaging information must be translated into the official languages of each target member state.

To ensure consistency, the EMA provides standardized QRD (Quality Review of Documents) templates that must be followed precisely. A formal linguistic review process is also conducted to assess translation quality and compliance across all EU/EEA countries.

High-quality translation is essential for meeting local pharmacovigilance standards and ensuring patient safety through consistent labeling and clear instructions for use.

PMDA (Japan)

The Pharmaceuticals and Medical Devices Agency in Japan requires all regulatory submissions to be provided in Japanese. Global pharmaceutical companies must translate core technical documents, including CTD modules, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and safety updates, into Japanese.

PMDA reviewers expect not only linguistic accuracy but also alignment with domestic terminology, scientific expression, and cultural context. Technical translations must reflect Japan’s regulatory nuances, and terminological consistency is essential, especially for product labeling, risk communication, and post-marketing materials.

Local review by in-country linguists with life sciences expertise is strongly recommended to meet PMDA expectations.

NMPA (China)

The National Medical Products Administration mandates that all regulatory submissions be in Simplified Chinese. This includes CTD documentation, labeling, patient leaflets, pharmacovigilance reports, and manufacturing information.

NMPA translation requirements are rigorous. Terms must align with Chinese pharmacopoeia, official drug dictionaries, and NMPA naming conventions. Translators must also account for local formatting rules and submission templates.

Due to differences in terminology structure and classification systems, accurate cross-lingual mapping of product information is essential. Failure to meet these requirements can delay market authorization or trigger rejections due to inconsistency or misinterpretation.

Document Types Requiring Translation

Successful regulatory submissions across global markets depend on the precise translation of a wide range of scientific, technical, and patient-facing documents. Regulatory authorities such as the FDA, EMA, PMDA, and NMPA require these documents in local languages to assess safety, efficacy, and quality. Below are key document types that frequently require translation during clinical development and product registration:

Common Technical Document (CTD Modules 1 to 5)

The CTD format is accepted globally and includes administrative information, summaries, quality data, nonclinical study reports, and clinical study reports. Module 1 is region-specific and often requires translation based on local authority language requirements. Modules 2 to 5 may also need translation to support cross-border submissions and local assessments.

Investigator Brochures (IBs) and Protocols

IBs contain essential preclinical and clinical data relevant to investigators. Protocols define the objectives and design of clinical trials. These documents must be translated accurately to ensure that trial sites and ethics committees fully understand the study plan and associated risks.

Informed Consent Forms (ICFs)

ICFs must be translated into the native languages of trial participants to meet ethical and regulatory requirements. The translation must be culturally appropriate and written in plain language while preserving legally required content.

Clinical Study Reports (CSRs)

CSRs provide detailed analyses of trial outcomes and are central to regulatory review. Translation of these complex documents requires subject-matter expertise to maintain consistency in medical terminology, statistical interpretation, and study context.

Drug Safety Update Reports (DSURs)

DSURs summarize global safety data for investigational products. When submitted to multiple regulatory authorities, accurate translation ensures that all safety signals, adverse events, and pharmacovigilance updates are clearly understood.

Summary of Product Characteristics (SmPCs)

The SmPC outlines the essential scientific information for healthcare professionals, including indications, dosage, contraindications, and adverse reactions. Translation must adhere to local regulatory templates and terminology standards to ensure consistent labeling across regions.

Patient Information Leaflets (PILs)

PILs are directed at patients and must be translated into the official language of each target country. Clarity, readability, and compliance with formatting guidelines are essential to promote proper usage and avoid health risks.

Packaging and Labeling Components

Product labels, cartons, and inserts must meet country-specific language and layout requirements. Accurate translation is critical to prevent medication errors and ensure product safety throughout distribution and use.

By ensuring that all these documents are translated by qualified linguists with regulatory expertise, life sciences companies can improve submission quality, reduce review cycles, and support successful global market entry.

Translation Quality Requirements

High-quality translation is essential for regulatory success across global markets. Regulatory agencies such as the FDA, EMA, PMDA, and NMPA expect submission materials to be scientifically accurate, linguistically precise, and fully aligned with their local language requirements. To meet these expectations, life sciences companies must follow rigorous translation quality protocols.

Native Language Scientific Translators with Regulatory Experience

All translations should be performed by professional linguists who are native speakers of the target language and have proven subject-matter expertise in regulatory affairs, clinical research, and pharmaceutical terminology. Their familiarity with regional regulatory expectations ensures that technical meaning is preserved and contextually appropriate.

Terminology Management and Controlled Vocabularies

Maintaining consistent terminology is critical in regulatory translation. Translators must align with established termbases and controlled vocabularies such as MedDRA for adverse event reporting and EDQM for pharmaceutical substances and dosage forms. Consistent terminology improves clarity, reduces ambiguity, and supports faster regulatory review.

Client Glossaries, Style Guides, and Regulatory Templates

To ensure alignment with sponsor preferences and local authority requirements, translators should leverage client-provided glossaries, style guides, and formatting templates. EMA QRD templates, PMDA-preferred phrasing, and NMPA formatting rules must be applied accurately. These resources help preserve brand voice, standardize output, and meet document structure expectations.

Certified Translation Standards: ISO 17100 and ISO 9001

Compliance with international quality standards such as ISO 17100 and ISO 9001 ensures that translation workflows are structured, traceable, and quality-controlled. ISO 17100 focuses on the qualifications of translators, revision processes, and client communication. ISO 9001 supports overall quality management and continuous improvement in translation operations.

Adhering to these quality requirements reduces the risk of translation-related rejection and supports timely regulatory approval. Partnering with a language service provider experienced in regulatory submissions is essential for maintaining compliance and protecting patient safety across international markets.

Common Challenges and How to Address Them

Regulatory translation for global submissions involves complex documentation workflows and strict compliance requirements. Life sciences companies must navigate a variety of linguistic, operational, and regulatory challenges to ensure submission success across multiple jurisdictions. Below are some of the most common issues and strategies to overcome them:

Managing Terminology Inconsistencies Across Regions

Pharmaceutical and regulatory terminology often varies by country, even when referencing the same concepts. For example, terms accepted by the EMA may differ from those preferred by the PMDA or NMPA. Without a centralized terminology management system, inconsistencies can occur across documents or language versions.

Solution:
Use translation memory tools and centralized termbases aligned with controlled vocabularies such as MedDRA and EDQM. Assign experienced linguists who understand regional terminology standards and regulatory preferences. Conduct terminology alignment reviews early in the process to avoid delays during submission.

Cultural and Linguistic Nuances in Patient-Facing Materials

Informed consent forms, patient leaflets, and other public-facing documents must be written in clear, culturally appropriate language. Literal translations may introduce misunderstanding, especially in sensitive areas such as risk communication or treatment procedures.

Solution:
Engage native-language translators with experience in health literacy and patient communication. Incorporate back translation and in-country review processes to validate clarity, tone, and cultural suitability. Follow health authority guidelines for plain language and readability requirements.

Handling Frequent Updates and Amendments in Submission Documents

Regulatory documents often go through multiple revisions before final submission. Keeping track of changes and ensuring consistency across all language versions can be difficult without structured version control.

Solution:
Implement a version-controlled translation workflow using cloud-based platforms that support real-time updates and change tracking. Maintain a master glossary and translation memory that updates dynamically as changes are made. Assign dedicated project managers to oversee synchronization across all document versions.

Coordinating Translations Across Multiple Languages and Tight Timelines

Large submissions may involve simultaneous translation into several languages under strict regulatory deadlines. Delays in any part of the process can impact the overall approval timeline.

Solution:
Plan translation needs early in the regulatory strategy. Work with a language service provider that offers scalable linguistic resources and automated project tracking. Use parallel workflows where possible and assign translators specialized by region and document type to maximize efficiency.

By proactively addressing these challenges, companies can reduce submission risk, streamline document preparation, and improve time to market for new therapies.

Best Practices for Regulatory Translation Projects

Effective regulatory translation requires more than linguistic accuracy. It demands rigorous project planning, deep regulatory expertise, and structured workflows to ensure quality, consistency, and compliance across all submission materials. The following best practices help life sciences companies optimize translation processes for FDA, EMA, PMDA, and NMPA submissions.

Engage Translators with Regulatory Subject-Matter Expertise

Regulatory content involves highly technical language, strict formatting rules, and jurisdiction-specific terminology. Translators must have advanced knowledge of clinical research, regulatory affairs, and local submission practices. Relying on generalist linguists introduces risk, particularly in documents like the CTD, SmPC, and safety reports.

Recommendation: Select native-language translators who have direct experience with regulatory submissions and are familiar with agency-specific expectations and terminological standards.

Implement Centralized Translation Memory and QA Tools

Translation memory (TM) and terminology databases ensure consistency across large and multi-phase projects. Centralized tools reduce turnaround time, lower costs, and improve quality by allowing previously translated content to be reused. Integrated QA tools also help identify terminology mismatches and formatting issues before delivery.

Recommendation: Use a translation management system (TMS) with secure, cloud-based TM access, real-time QA checks, and support for multi-language workflows. Maintain centralized terminology glossaries aligned with MedDRA, EDQM, and ICH standards.

Plan for Early Translation Reviews in Submission Timelines

Delaying translation until the final stages of document development increases the risk of errors and last-minute delays. Early linguistic input can improve clarity, resolve terminology questions, and support parallel workflow strategies.

Recommendation: Incorporate translation milestones into the submission timeline from the outset. Coordinate with document authors and regulatory affairs teams to identify which sections can be translated as they are finalized.

Collaborate with In-Country Reviewers When Needed

Local experts help ensure translations are culturally appropriate, technically accurate, and aligned with health authority expectations. Their feedback is particularly valuable for patient-facing materials and jurisdiction-specific formatting requirements.

Recommendation: Establish a structured in-country review process involving native-speaking medical or regulatory professionals. Use tracked changes and feedback loops to resolve discrepancies efficiently.

Validate Translations Through Back-Translation or Linguistic Reconciliation

For high-risk documents such as informed consent forms, risk management plans, or regulatory summaries, additional validation steps enhance quality and minimize legal liability.

Recommendation: Use back-translation or linguistic reconciliation to confirm the fidelity of translations. These techniques involve re-translating the content into the original language and comparing both versions to identify errors or ambiguities.

By applying these best practices, organizations can improve translation quality, reduce compliance risk, and accelerate regulatory approval across global markets.

Sesen’s Regulatory Translation Expertise

Sesen provides specialized regulatory translation services for life sciences companies seeking approval across global markets. Our solutions support pharmaceutical, biotechnology, and medical device firms in preparing multilingual submissions that meet the linguistic, technical, and formatting requirements of leading health authorities, including the FDA, EMA, PMDA, and NMPA.

Our regulatory translation services cover the full spectrum of submission documents, including CTD modules, clinical study reports, investigator brochures, informed consent forms, SmPCs, patient leaflets, and product labeling. We support every stage of the regulatory lifecycle, from early clinical development through post-marketing safety reporting.

Sesen’s quality management system is certified to ISO 17100, the international standard for translation services, as well as ISO 9001 and ISO 13485, which govern quality assurance and medical device documentation. These certifications demonstrate our commitment to delivering accurate, consistent, and compliant translations in highly regulated environments.

Our global team includes native-language translators with subject-matter expertise in regulatory affairs, clinical research, and pharmacovigilance. Using secure, centralized translation memory and terminology management systems, we maintain consistency across projects while meeting country-specific submission expectations.

Sesen has successfully supported multilingual submissions to the FDA in the United States, the EMA in the European Union, the PMDA in Japan, and the NMPA in China, among other national regulatory bodies. Our experience includes working with clinical-stage biotechs and established global pharma companies to deliver high-quality translations under tight timelines and evolving regulatory requirements.

Client example (optional):
A recent project involved translating a full IND dossier from Simplified Chinese into English, French, German, Japanese, and Traditional Chinese to support parallel submissions across multiple jurisdictions. The project included over 300,000 words across CTD modules, clinical data summaries, and local labeling components, all delivered within six weeks under strict QA protocols.

By partnering with Sesen, regulatory teams gain a trusted language services provider with proven experience in supporting global submissions with speed, precision, and compliance.

Accelerating Global Submissions Through Specialized Regulatory Translation

Achieving regulatory approval across international markets requires more than scientific rigor. It demands precise, compliant translation tailored to the expectations of each target health authority. From CTD modules to patient-facing materials, every document must be linguistically accurate, culturally appropriate, and technically aligned with local requirements.

Working with a specialized language partner that understands the nuances of FDA, EMA, PMDA, and NMPA submissions is essential. A qualified provider brings not only linguistic expertise but also deep knowledge of regulatory terminology, formatting standards, and quality assurance protocols.

By investing in high-quality regulatory translation, life sciences companies can reduce the risk of submission delays, improve communication with authorities, and accelerate market access for new therapies. Consistent, well-executed translation enhances compliance and supports successful outcomes throughout the product development lifecycle.

Stepes and Sesen are committed to supporting global regulatory teams with scalable, high-precision translation services that meet the demands of today’s evolving life sciences landscape.

Need Accurate Translations for Your Global Submissions?

Partner with Sesen to ensure your multilingual regulatory documentation meets the language, format, and compliance requirements of the FDA, EMA, PMDA, and NMPA. Our specialized translation services help accelerate global approvals and reduce submission risk.

 
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