Pharmaceutical and regulatory translation covers the documents submitted to regulatory authorities so that a medicine can be placed on the market. These documents are reviewed by authorities such as Titck in Türkiye, the EMA in Europe and the FDA in the US, so a translation that is merely accurate in its terminology is not enough it must also follow the format and template the authority expects.
Below you will find how the dossier is structured, which documents it contains and what the translation has to get right.
A marketing authorisation application is not a single document but an interlinked dossier that is updated throughout the product’s life cycle.
Translation is embedded in that whole: it comes into play at the initial application, with every variation and with each safety update. Regulatory translation is therefore not a one-off job but a process that spans years and demands consistency.
Each document in the dossier has its own reader and its own rules.
In most markets the dossier is organised in the common technical document (eCTD) structure, which has five modules: regional and administrative information (Module 1), summaries (Module 2), quality (Module 3), non-clinical studies (Module 4) and clinical studies (Module 5). Which modules must be submitted in which language depends on the target authority; the regional module and the summaries in particular are expected in the local language and in full consistency.
The SmPC is the product’s official information document for healthcare professionals: indications, posology, contraindications, warnings and adverse effects are all set out here.
It must follow the EMA’s QRD template in Europe and the SmPC format defined by Titck in Türkiye to the letter; heading structure, order and approved terminology are not open to interpretation.
The package leaflet is aimed at the patient; it is the SmPC’s information rendered in plain, comprehensible language. In the European Union, package leaflets are expected to undergo readability testing with the target audience.
The most critical point in translation is full consistency between the SmPC and the leaflet: if the same information is expressed differently in the two documents, the application comes back.
Inner and outer packaging texts must fit a limited space and contain specific mandatory statements.
Abbreviations, symbols and units are written according to the rules of the target market; the smallest omission can prevent the packaging from being approved.
Once the authorisation is granted, every change a new indication, a dosage change, a safety update is notified through a variation application. These applications must be fully consistent with the earlier documents, which is why version control and translation memory are indispensable in regulatory translation.
In correspondence with regulatory authorities, not only is terminological accuracy important, but so is consistency with previous applications and statements.
The common technical file standardizes the content of the regulatory application under specific modules.
Assessment of the target market, document type, and regulatory requirements .
Creation of a product-based glossary, reference documents, and a translation memory.
Translation of the content by experts with a strong command of medical and pharmaceutical terminology.
Independent editorial review of the translation and verification of terminology consistency.
Ensuring that previously approved terminology is retained in variations and updates.
Regulatory requirements vary depending on the target market. In Turkey, the TİTCK; in Europe, the EMA and relevant national authorities; and in the U.S., the FDA are the primary examples of regulatory bodies.
For KÜB, instructions for use and label texts in most markets follow standard templates and approved terminology. In Europe, the QRD templates are one of the most prominent examples of this.
For this reason, regulatory translation is not a free-form text adaptation; rather, it is a disciplined process that adheres to templates, terminology, product history, and the target authority’s rules.
In these documents, consistency is everything: the same term must appear in the same form across all of a product’s documents and in every later variation application. Approved glossaries and translation memory make this possible, and every text is edited by an independent editor. A single inconsistency between an SmPC and its package leaflet can be enough to send an application back.
For this reason, terminology consistency is ensured by using project-specific approved terminology glossaries, reference documents, and translation memory .
Product- and customer-based terminology resources.
Systematic preservation of previously approved content.
A second-language expert review, independent of the translation.
Use of existing approved documents as a basis for variations.
The problems encountered most often are: giving the SmPC and the leaflet to different translators and losing consistency between them; changing the heading order of the QRD or Titck template; using free equivalents instead of approved terminology; not basing a variation application on the previous version; and failing to adapt mandatory statements or unit conventions in packaging texts to the target market. Each of these leads to a return from the authority and a delay.
The documents are subject to authority approval and must follow standard templates and approved terminology, so both medical/pharmaceutical knowledge and command of the regulatory format are required.
Compliance with the official template (EMA QRD or the Titck format) and approved terminology, and full consistency between the SmPC and the leaflet.
It is the five-module standard electronic structure of the dossier; which modules are submitted in the local language depends on the authority, with full consistency expected especially in the regional module and the summaries.
It depends on the target market: Titck for Türkiye, the EMA and national authorities for Europe, and the FDA for the US are the main examples.
They must be fully consistent with earlier documents; a difference in terms can lead to rejection or delay.
Through approved glossaries and translation memory, with every text edited by an independent editor.
Specialising in medical translation for over thirty years, Mirora ISO 9001 certified, with an ISO 17100-aligned workflow is the translation partner of choice for leading pharmaceutical companies.
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