Why translating core dossiers for marketing applications requires more than language skills

The global shift towards electronic Common Technical Document (eCTD) submissions has reached critical momentum. Regulatory agencies worldwide now expect life science organisations to adhere to eCTD standards, not just for new drug applications but also for ongoing lifecycle management, clinical trial approvals and marketing applications. With this shift, the demand for precise and compliant translations of core dossier components has risen. In an increasingly competitive landscape, pharmaceutical companies face mounting pressure to expedite global filings, while maintaining high quality and compliance standards. Regulatory complexity continues to increase as health authorities enforce region specific requirements alongside global guidelines. In this blog we outline why adoption of eCTD dossiers has increased and why translation requires regulatory expertise as well as language skills.

eCTD dossier adoption and structure

Although not mandatory in every market yet, sponsors across the world have shown a preference for eCTD. They recognise that the common structure and electronic format make it easier to identify, manage and submit updates. This allows regulatory authorities to locate and compare them easily. Formatting is prescribed and consistent, all eCTD dossiers follow the same structure and provide regulatory agencies with the necessary information to make decisions about drug approvals for their region.

Because of the detailed information included, eCTD dossiers can contain hundreds, or even thousands of pages. Despite their volume, their structure and formatting are universal. All eCTD dossiers are divided into five distinct modules, as shown in the CTD Triangle below.¹

When an eCTD dossier translation may be required

If you obtain a compound that has already been approved in one geographic region and plan to market it in another region through a new drug application, you might need a complete eCTD dossier translation. For example, if your drug is approved for use in Japan, the final eCTD dossier would have been submitted in Japanese. However, if your company intends to distribute and hold Rest of World (RoW) rights, the new submission must be made in English once the acquisition process is complete.

Why Regulatory and Translation teams should be in sync

As well as being lengthy, eCTD dossiers are highly technical. Any errors with consistency, grammar, or formatting can stall approval. Mistranslations can cause delays, the loss of a commercial advantage, and quickly add up to millions of dollars in lost revenue. It is crucial for the translation team working on these projects to have direct access to regulatory experts to consult on the language, formatting and structure that regulatory authorities will demand.

Collaborating with a translation team within a CRO is advisable to ensure that your eCTD dossier benefits from the necessary regulatory expertise. As an in-house CRO translation team, ICON Language Services collaborates with regulatory, clinical and therapeutic experts. This reduces delays in information-seeking and ensures that the translation is accurate and compliant. With locations in more than 40 countries our specialists can translate into over 300 languages.

While eCTD dossiers have a common structure and format, every dossier is unique. ICON Language Services has a flexible approach to meet different sponsors’ needs. A regulatory project manager with expertise in end-to-end regulatory submissions oversees the entire translation process and final eCTD formatting tasks. This ensures that the translation meets the quality standards and timelines agreed with the sponsor as well as the regulatory authorities’ requirements.

Staying ahead in a competitive market

CTD and eCTD dossiers help sponsors and regulatory authorities to organise the large volume of information necessary for a drug approval. When seeking approval for a product in a new market, the stakes are high. Even small delays can have a ripple effect, disrupting a carefully crafted launch strategy. Seeking support from a language service embedded in a CRO ensures that your eCTD dossier translation is accurate and managed appropriately. As regulatory frameworks evolve and pharmaceutical companies acquire products to expand into new markets, our ICON language and regulatory teams can expedite your eCTD dossier submission process and help your product reach new markets sooner.

Partner with ICON Language Services to accelerate your core dossier submissions.

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Reference

¹M4: The Common Technical Document. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. https://www.ich.org/page/ctd Published 2008. Accessed 22 January, 2025.

eCTD dossier adoption and structure

When an eCTD dossier translation may be required

Why Regulatory and Translation teams should be in sync

Staying ahead in a competitive market

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