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CTD and eCTD Translation Expertise for Regulatory Approval

The Common Technical Document (CTD) and electronic Common Technical Document (eCTD) are standardized submission formats required by global health authorities such as the FDA, EMA, PMDA, and NMPA. These formats organize regulatory content into five modules covering quality, nonclinical, and clinical data, along with region-specific administrative information.

CTD and eCTD submissions are essential for gaining approval of new drug applications, biologics, and generics across international markets. Regulatory agencies increasingly require content to be submitted electronically and in the local language of the reviewing body.

Accurate, high-quality translation of CTD and eCTD materials is critical to achieving regulatory approval. Errors or inconsistencies in translated content can result in delays, rejections, or noncompliance. Translation must align with strict formatting, version control, and therapeutic-specific terminology standards.

Sesen provides specialized CTD and eCTD translation services that meet the demands of regulatory teams worldwide. Our life sciences focus, technical precision, and proven workflows support successful submissions across all major regions.

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What Are CTD and eCTD?

The Common Technical Document (CTD) is a globally harmonized format for organizing and submitting regulatory information related to pharmaceuticals and biologics. It was developed by the International Council for Harmonisation (ICH) to streamline the drug approval process across different regions. CTD submissions are typically paper-based or compiled into PDF files.

The electronic Common Technical Document (eCTD) is the digital version of the CTD. It incorporates an XML backbone and standardized folder structure that allows regulatory authorities to receive, review, and archive submission content electronically. The eCTD is now the preferred and often required format by most regulatory bodies.

Both CTD and eCTD formats are accepted by major health authorities, including:

  • FDA (United States)
  • EMA (European Union)
  • PMDA (Japan)
  • NMPA (China)
  • Health Canada
  • Swissmedic and others

These formats are required for a wide range of regulatory filings, such as:

  • New Drug Applications (NDA)
  • Biologics License Applications (BLA)
  • Abbreviated New Drug Applications (ANDA)
  • Marketing Authorization Applications (MAA)
  • Investigational New Drug (IND) submissions
  • Investigator’s Brochures (IB)
  • Investigational Medicinal Product Dossiers (IMPD)

Standardizing the format across regions enables sponsors to reuse core documentation across multiple markets, reducing cost and time to market. However, many components still require language-specific adaptations or full translation depending on the target health authority.

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CTD and eCTD Module Overview and Translation Requirements

CTD and eCTD submissions are structured into five standardized modules, each containing specific categories of regulatory content. Understanding the function of each module is essential to identifying where translation is required for global submissions. Health authorities such as the EMA, PMDA, and NMPA often require full or partial translation of Modules 1 through 5, depending on their language and format specifications.

Each module plays a distinct role in the submission package and carries unique translation challenges. Below is a summary of the CTD module structure and its translation relevance:

Module

Name

Content Summary

Translation Relevance

Module 1

Regional Information

Country-specific documents such as cover letters, application forms, labeling content, and risk management plans

Requires translation and formatting based on local regulatory guidance. Terminology and structure vary by agency

Module 2

CTD Summaries

High-level summaries of quality data, nonclinical study results, and clinical trial outcomes

Typically translated in full for non-English-speaking regulators. Must align with terminology in Modules 3 through 5

Module 3

Quality (CMC)

Chemistry, manufacturing, and controls data, including stability studies and analytical methods

Requires high linguistic and scientific accuracy. Terminology must reflect technical specifications and production standards

Module 4

Nonclinical Study Reports

Preclinical pharmacology and toxicology reports, including safety and efficacy data from animal studies

Often partially or fully translated depending on the submission scope and local agency requirements

Module 5

Clinical Study Reports

Clinical trial protocols, statistical analysis plans, investigator brochures, and patient narratives

High translation demand across international markets. Commonly submitted in local language to EMA, PMDA, and NMPA

To support efficient review and minimize regulatory delays, translations must adhere to strict formatting, referencing, and terminology standards across all modules. Sesen works closely with regulatory teams to align translated content with source documents, validated glossaries, and agency-specific templates.

Why Accurate CTD and eCTD Translation Matters

Accurate translation is essential to the success of CTD and eCTD submissions. Regulatory bodies such as the EMA, PMDA, and NMPA expect submission materials to be linguistically precise, technically accurate, and fully aligned with their formatting and terminology standards. Any deviation can result in clarification requests, delayed approvals, or outright rejection.

CTD and eCTD files must maintain consistency across all modules, especially when preparing initial applications, managing follow-up submissions, or submitting amendments. Terminology must be harmonized throughout Modules 2 through 5 to ensure clarity for regulatory reviewers and alignment with source documentation.

Common translation challenges include:

  • Misinterpretation of critical CMC content in Module 3 that can lead to compliance issues during manufacturing inspections
  • Inconsistencies between summary documents in Module 2 and detailed reports in Modules 4 and 5
  • Mismatched terminology between translated clinical study protocols and patient narratives in Module 5
  • Incorrect rendering of regional labeling elements in Module 1 due to local regulatory nuances

Sesen mitigates these risks through validated glossaries, structured QA workflows, and close collaboration with sponsor regulatory teams. Our translations are prepared by experienced life sciences linguists with deep knowledge of CTD structure and country-specific requirements.

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Sesen’s Specialized CTD and eCTD Translation Services

Sesen delivers highly specialized translation services tailored to the requirements of CTD and eCTD submissions. Our focus on life sciences ensures linguistic precision, regulatory compliance, and full alignment with global submission standards.

Our services include:

All translations are performed by linguists with advanced scientific backgrounds and deep familiarity with CTD structure, therapeutic terminology, and submission protocols required by agencies such as the EMA, PMDA, and NMPA.

We create and maintain dedicated terminology databases to ensure consistency across all modules and submission cycles. Our linguists align closely with client style guides and regulatory templates to meet agency expectations.

We collaborate with regulatory publishing teams to ensure translated documents are submission-ready, properly formatted, and compatible with XML-based eCTD publishing platforms.

In addition to core CTD content, we translate essential supporting materials such as the Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and regulatory labeling documents.

Sesen supports direct integration with sponsor systems such as Veeva Vault, MasterControl, and other validated platforms. This enables secure file handling, version tracking, and efficient content deployment across projects.

Our CTD and eCTD translation services are designed to support regulatory compliance, reduce submission risk, and accelerate time to approval in global markets.

Quality Assurance and Regulatory Compliance

Sesen applies rigorous quality management protocols to ensure the accuracy, consistency, and regulatory compliance of all CTD and eCTD translations. Our workflows are built around globally recognized standards and tailored to meet the specific requirements of life sciences regulatory submissions.

Our quality system is certified to ISO 17100 for translation services, ISO 13485 for medical device documentation, and ISO 9001 for general quality management. These certifications reflect our commitment to delivering high-quality, audit-ready translation solutions that meet industry and regulatory expectations.

For key target markets, Sesen offers in-country and bilingual review by subject matter experts who understand local regulatory context and therapeutic terminology. This additional layer of validation helps align translated content with reviewer expectations and regional submission preferences.

We support agency-specific linguistic validation requirements, such as PMDA-compliant phrasing in Japanese, EMA stylistic conventions, and NMPA documentation formatting. Our teams work closely with sponsor regulatory staff to localize terminology and maintain consistency across all submission modules.

All CTD and eCTD translation projects undergo a structured multi-step QA process, including independent linguistic review, terminology checks, formatting validation, and pre-delivery verification. We maintain version control and audit trails to support traceability, document history, and regulatory audits.

Sesen’s quality framework ensures that every translated submission is precise, regulator-ready, and fully aligned with international standards.

Supported Languages and Global Regulatory Regions

Sesen provides CTD and eCTD translation services in all major languages required for international regulatory submissions. We support life sciences companies in preparing region-specific dossiers that meet the linguistic and formatting requirements of health authorities worldwide.

Our language capabilities are aligned with the expectations of key regulatory regions, including:

  • European Medicines Agency (EMA):
    German, French, Spanish, Italian, Dutch, Polish, Swedish, Czech, and other official EU languages
  • Pharmaceuticals and Medical Devices Agency (PMDA):
    Japanese translation with strict adherence to local phrasing, terminology, and formatting standards
  • National Medical Products Administration (NMPA):
    Simplified Chinese translation with specialized support for CMC, clinical, and labeling documentation
  • Gulf Cooperation Council (GCC) countries:
    Arabic translation for submissions to health authorities in the UAE, Saudi Arabia, and neighboring markets
  • Latin America (LATAM):
    Spanish (LATAM) and Brazilian Portuguese for submissions to ANVISA, COFEPRIS, INVIMA, and other agencies across the region

Sesen also supports multilingual submissions for Canada, Switzerland, South Korea, ASEAN markets, and other emerging regulatory regions. All translations are delivered by native linguists with regulatory expertise and validated through structured quality assurance workflows.

Use Cases and Real-World Applications

Sesen supports global life sciences companies across a range of regulatory translation scenarios. Our experience spans initial submissions, agency responses, and post-approval updates, ensuring accurate, submission-ready content across all CTD and eCTD modules.

Common use cases include:

  • EMA Submission for Marketing Authorization Application (MAA):
    Full translation of CTD Modules 2 through 5 into required EU languages, including quality summaries, nonclinical reports, and clinical study documentation, aligned with EMA formatting and terminology expectations.
  • PMDA Dossier Preparation for Japanese Regulatory Review:
    Translation of clinical trial protocols, patient narratives, and statistical analysis plans into Japanese, using PMDA-preferred phrasing and formatting. Includes bilingual alignment with global master files to maintain consistency.
  • NMPA CMC Section Localization for China IND:
    Precise translation of Module 3 content, including manufacturing processes, stability data, and analytical methods. Tailored to meet NMPA formatting and submission standards.
  • Variation Filing and Lifecycle Management Translations:
    Ongoing support for updates to previously submitted CTD and eCTD content, including labeling changes, safety updates, and manufacturing variations. Version control and terminology consistency are maintained across all updates.

Sesen’s regulatory translation workflows are designed to support sponsors from early-phase development through post-market surveillance, helping ensure compliance and accelerated approval timelines.

Case Study: CTD Translation Support for a Global Oncology Submission
Learn how Sesen supported a multinational pharmaceutical company with multilingual translation of CTD Modules 2 through 5 across five regions, enabling simultaneous MAA and IND filings.

Why Choose Sesen for CTD and eCTD Translation Services

Sesen is a trusted partner to regulatory and clinical affairs teams worldwide. Our exclusive focus on life sciences translation ensures that every CTD and eCTD submission is accurate, compliant, and regulator-ready. We combine deep subject matter expertise with advanced project coordination to support even the most complex global filings.

What sets Sesen apart:

We specialize exclusively in the translation of regulatory, clinical, and technical content for the pharmaceutical, biotechnology, and medical device sectors. This singular focus allows us to meet the strictest industry standards for terminology accuracy and data integrity.

Our translators are native-speaking professionals with proven experience in regulatory translation and subject matter knowledge across therapeutic areas, including oncology, rare disease, infectious disease, and immunology.

We work in close collaboration with sponsor teams, CROs, and regulatory consultants to ensure translated content is delivered in alignment with submission schedules, technical templates, and agency formatting expectations.

Sesen provides proactive project updates, version-controlled deliverables, and secure file management. Our workflows are designed to support fast turnaround requests, rolling submissions, and dynamic filing timelines.

Whether you are submitting an initial NDA, updating your MAA, or preparing IND documentation for a new region, Sesen delivers the regulatory translation support you need with precision and confidence.

Need Expert CTD and eCTD Translation for Your Next Regulatory Submission?

Partner with Sesen for accurate, regulator-ready translations across all CTD modules. Our life sciences experts deliver compliant, high-quality language support for FDA, EMA, PMDA, NMPA, and other global submissions.

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