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EMA Updates Linguistic Review Process for Human Medicines

The European Medicines Agency (EMA) has published an updated document explaining how product information for centrally authorised human medicines is reviewed before and after marketing authorisation. The process is designed to ensure that product information is accurate, consistent, and compliant across all European Union languages.

The document, titled The linguistic review process of product information in the centralised procedure — Human medicinal product applications, was published on 10 February 2025 as revision 6. The full EMA document is available here: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/linguistic-review-process-product-information-centralised-procedure-human_en.pdf.

Two Stages of Review

The EMA process is divided into two principal stages. Before the Committee for Medicinal Products for Human Use (CHMP) adopts its opinion, the Agency and relevant reviewers assess the English product information. After a positive opinion, the approved English text is translated into the other EU languages and reviewed by the Member States.

The product information covered by the process includes:

• The Summary of Product Characteristics (SmPC)
• Labelling information
• Package leaflets
• Annexes associated with the marketing authorisation
• Relevant product information affected by post-authorisation procedures

This approach is intended to ensure that healthcare professionals and patients receive consistent information regardless of the language in which the medicine is supplied.

Strict Regulatory Timelines

For a new marketing authorisation application, applicants must generally submit translations in all applicable EU languages no later than five days after the CHMP opinion. The Member States then review the translations, typically between Day 215 and Day 229, after which applicants have a short period to implement comments and submit final versions to the EMA.

The final submission must include:

• Word files showing tracked changes
• Clean Word files
• Clean PDF files
• The appropriate QRD forms
• Any required justifications for comments that were not implemented

For initial applications and certain variations, the final translations are generally submitted by Day 235, creating a 25-day post-opinion linguistic review process. The timelines are calculated in calendar days rather than working days, making advance preparation essential.

Scope Beyond New Applications

The EMA guidance also covers several post-authorisation procedures that may affect product information. These include Type II variations, Type IB variations, grouped procedures, work-sharing variations, renewals, referrals, periodic safety updates, and results from post-authorisation safety studies.

Type IA variations generally do not undergo a full linguistic review in all other EU languages. In those cases, the marketing authorisation holder remains responsible for ensuring that the translations are correct and compliant. More substantial changes, particularly those associated with Type IB or Type II variations, may require Member State linguistic review.

Importance of Translation Quality

The EMA places considerable responsibility on applicants and marketing authorisation holders to provide high-quality translations prepared by reputable providers with expertise in medical terminology. Poor-quality translations, incomplete implementation of Member State comments, or missing documentation may delay transmission of the final materials to the European Commission.

The guidance also stresses the importance of complying with the QRD Convention, including requirements for terminology, formatting, layout, margins, and document presentation. These technical details are not merely cosmetic: they help ensure that product information remains consistent across medicines and languages.

Implications for Medical Translators

For translators and localization professionals, the EMA process illustrates the highly structured nature of pharmaceutical regulatory translation. Success requires more than linguistic fluency; it also depends on familiarity with:

• European regulatory terminology
• SmPC and package leaflet conventions
• QRD templates and forms
• Tracked-changes workflows
• Multilingual consistency checks
• Tight regulatory deadlines
• Responses to national authority comments

The process also demonstrates why pharmaceutical companies are encouraged to begin translation work well before the formal post-opinion deadline. Although the official translation review starts after the CHMP opinion, early preparation can help applicants manage terminology, formatting, queries, and quality assurance within an extremely compressed timetable.

A Coordinated Multilingual Process

The EMA’s linguistic review system reflects the collaborative nature of European medicines regulation. Applicants, marketing authorisation holders, EMA reviewers, QRD members, national authorities, medical writers, and translation providers all contribute to the final product information.

For small and medium-sized enterprises, the EMA provides additional support in certain new application procedures. The European Commission’s Translation Centre may prepare translations for some EU languages, while the SME applicant remains responsible for other language versions and may request opportunities to comment on specific translations.

The EMA document provides an important reference for pharmaceutical companies, regulatory affairs teams, medical writers, and translators involved in centrally authorised human medicinal products. It shows how linguistic review is integrated into the wider regulatory decision-making process and how translation quality can affect the timing of a medicine’s approval and subsequent updates.