Quality Assurance during the Linguistic Review process

For certain medicines, the European Medicines Agency (EMA) allows pharmaceutical companies to submit a single Marketing Authorisation (MA) application through the centralised procedure. After the adoption of the Committee for Medicinal Products for Human Use (CHMP) Opinions comes the Linguistic Review process.

This Linguistic Review involves translating product information from the approved English version into all European Union (EU) languages, as well as Norwegian and Icelandic. Following strict guidelines from the EMA, the goal is to ensure the accuracy, consistency, and quality of translated content in all Member States. In this article, we explore some key quality assurance techniques employed during the process.

1. Analysis of the source text

Analysing the source text is crucial to both the translation and quality assurance processes, as this helps the team gain a comprehensive understanding of the domain and context. By cross-referencing and validating terms, language service providers can create and use terminology databases, glossaries, and reference materials. This guarantees that terms are used consistently and accurately throughout translated materials.

At Intertranslations, we also use this initial step to identify any wider linguistic challenges that may cause issues during the translation process. By highlighting these segments, our project managers can allocate additional time and resources to ensure that these areas receive the necessary attention and a thorough revision.

2. Qualified linguistic experts

One of the underlying pillars of quality assurance is the use of highly qualified translators. These professionals must possess specialist knowledge of medical and regulatory terminology, as well as EMA guidelines. This guarantees that translations effectively communicate the intended message to the target audience – both healthcare professionals and patients alike.

To make sure that we select the right team, we group our medical translators into sub-categories that highlight their areas of expertise, such as cardiology, diabetes or neurology. This targeted approach enhances the quality and accuracy of our translations, reducing the risk of errors or misunderstandings.

3. Compliance with Quality Review of Documents (QRD)

The QRD templates provide standardised content for translating the Summary of Product Characteristics, Labelling and Package Leaflets into Norwegian, Icelandic and all EU languages. Compliance is essential for ensuring the accuracy, consistency and harmonisation of the product information. By adhering to QRD templates, pharmaceutical companies can meet the linguistic regulatory requirements for submitting product information and avoid any potential delays in approval.

Our computer-assisted translation (CAT) tool has all the QRD templates and applicable appendices incorporated into our translation memories (TMs). This streamlines the Linguistic Review process and helps save time by allowing our translators to focus on new and modified content instead. Since the templates are constantly being reviewed, we also make sure to update our TMs as soon as new versions are released.

4. EMA terminology resources and guidelines

Effective terminology management helps standardise the translations of medical-pharmaceutical terms, which in turn ensures harmonisation and clarity. The Linguistic Review must comply with the resources and guidelines provided by the EMA. These outline preferred specific terms, stylistic matters, formatting conventions, and other requirements for translated documents. Some examples of guidelines and resources include MedDRA, EMA medical terms simplifier, Standard Terms, Regulatory Authority Guidelines and Glossaries, and IATE.

At Intertranslations, we add these resources to our own terminology database and also collect terminology from other medicinal products approved in similar ATC codes. This facilitates quality control, allowing our Linguistic Review team to ensure that the terminology used in the translation aligns with the texts that have already been approved, preventing any errors or inconsistencies.

5. Quality control

Rigorous linguistic control measures should also be implemented during the Linguistic Review process, which means additional revision and proofreading. These tasks must be performed to identify any errors, inconsistencies, or omissions that may have occurred during the initial translation stage. This meticulous quality control process also helps to improve the translation’s readability, ensuring that the content aligns with the intended purpose and target audience.

At Intertranslations, we also use Language Quality Inspection (LQI) to review any complex segments identified during the initial analysis of the source text. By conducting this third review step, we can address and rectify any issues, ensuring the final deliverables meet the required linguistic quality standards.

6. Communication between the MA applicant and the Member States

This is one of the most ignored aspects of quality control, and yet communication plays an integral role in the Linguistic Review process. After Day 215/+5, Member States may have queries or require clarifications regarding the translation or specific terms in the documents. They may also propose amendments to the translations, highlighting areas that require revisions or improvements.

At Intertranslations, we help the MA applicant communicate with the Member States and exchange queries, feedback, and clarifications. This feedback is then considered during subsequent iterations of the Linguistic Review process to ensure the accuracy and quality of the translations.

7. Document formatting and final layout

After all comments from the Member States have been addressed, it is important to make sure the final versions of the product information are properly prepared. All headings, subheadings, tables, figures, and other elements must be correctly formatted in line with the regulatory guidelines and QRD convention. This enhances the readability of the translations and allows the MA applicants to generate PDF versions that fulfil the requirements on the QRD form 2.

Aided by translation software, the formatting of all our translations is identical to the English source files and therefore in compliance with the QRD conventions. For example, headings, line spacing or character spacing are automatically applied to the target text. We also perform a visual check before generating the PDF versions to avoid any issues. This ensures that all of our translated documents follow the regulatory requirements, helping simplify the approval process.

By implementing robust quality control measures like those mentioned, pharmaceutical companies and language service providers can maintain high standards of quality during Linguistic Reviews. This keeps product information accurate and consistent across all languages, ensuring regulatory compliance and product safety while supporting market expansion.

At Intertranslations, we have over 20 years of experience working with regulatory authorities and health ministries. Our expertise in pharmaceutical translations means we understand complex regulations, which further enhances the linguistic quality of our translations. With a broad network of specialist translators and subject-matter experts, we are committed to delivering high-quality translations using the latest technology. Our focus on accuracy and consistency is also accompanied by strict confidentiality and data protection standards.

Are you looking for a pharmaceutical translation agency known for its exceptional quality and premium services? Contact our pharmaceutical translation specialists.