Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing

By Farah Ayadi, PharmD, medical-linguistic consultant, and Stephen O’Sullivan, senior medical and pharmaceutical linguist

It is often assumed that strict compliance with medical translation regulatory requirements, such as adherence to Quality Review of Documents (QRD) templates, MedDRA coding, and European Directorate for the Quality of Medicines & HealthCare (EDQM) terminology, is sufficient to produce a correct target-language document (i.e., French in this article). While compliance is compulsory, it does not automatically guarantee clarity or immediate comprehension by the intended audience. Excessive proximity to English phrasing not only produces non-idiomatic French but may also reduce clinical readability, with potential implications for safety, regulatory submissions, and downstream operational or financial outcomes.

Rather, a linguistically informed approach, balancing regulatory compliance, idiomatic French usage, and recognized linguistic standards, significantly improves both the clarity and credibility of regulatory documents.

The terminological considerations discussed in this article apply primarily to French as used in France, which broadly aligns with conventions followed by other French-speaking regulatory contexts (e.g., North African countries). Terminology localization remains crucial in regulatory medical translation, as variations across some French medical terms may affect clarity and comprehension by healthcare professionals. While the examples in this article focus on French regulatory documentation, similar linguistic and terminological challenges may arise in other languages, making a comparable risk-aware approach essential across multilingual regulatory contexts.

1. General Regulatory Principles

Strict compliance with regulatory templates is a non-negotiable prerequisite in regulatory writing. The level of requirement is particularly high for Product Information (PI), including the Summary of Product Characteristics (SmPC). Marketing authorization applicants, regulatory affairs teams, and translation or localization professionals involved in preparing these documents in multinational contexts, are required to follow the most recent QRD templates in full, including all associated annexes and appendices, without deviation. For national authorization, decentralized, and mutual recognition procedures (NAT/DCP/MRP), they must use templates approved by the relevant regulatory authorities, such as the ANSM T10 templates for French dossiers.

Apart from templates, compliance with additional regulatory requirements is compulsory. These include authorized abbreviations, excipient guidelines, formatting rules, stylistic conventions, and QRD decisions governing the use of specific terms. Failure to comply with any of these requirements may result in regulatory queries, even when the scientific content itself is correct.

While certain EMA terminological recommendations primarily target English, they can be useful in a translation context for identifying and flagging noncompliance in source documents. Typical examples include replacing non-recommended terms, such as medication or drug with medicinal product in a SmPC, using sodium chloride solution (with the specified concentration, e.g., 9 mg/ml) instead of saline solution, or using the authorized form of abbreviations, e.g., ECG instead of EKG, or C_max instead of Cmax.

Certain terminological and conceptual principles can also be extrapolated into French in sensitive regulatory contexts, typically with regard to the age classification within the pediatric population, according to the EMA guidance. For example, imprecise terms such as young children, and their French equivalent "jeunes enfants," should be avoided. Although the term toddler has a distinct meaning in general English usage, infants and toddlers are often grouped together and should be translated as "nourrissons" when referring to subjects or patients aged 28 days to 23 months.

Similar considerations apply to other terminological choices, such as the use of "glucose" rather than "dextrose," or avoiding "VIH+" and "VIH-" in favor of "séropositif au VIH" and "séronégatif au VIH."

Issues or errors in the source text should never be transferred mechanically into the target document. Any identified terminological inconsistency or noncompliance should be flagged, with a clear recommendation for the appropriate term or phrasing, as regulatory translation must extend beyond linguistic equivalence to ensure both compliance and clarity and anticipate regulatory queries.

2. Key Responsibilities In The Translation Process

When drafting or translating a regulatory document, the output must remain free of personal stylistic or creative choices and should not blindly follow the source document where it does not fully comply with regulatory requirements. For example, the QRD template, including its standardized structure, headings, and mandatory wording take precedence over the source document. Any deviation, inconsistency, or noncompliance must be systematically identified and flagged.

That said, variation or deviation from the source document is rarely welcomed when not justified, and the meaning must remain faithful in any regulatory context: no interpretation, addition, or omission is acceptable without the client’s explicit agreement and documented justification. Thus, regulatory translation requires a careful balance between fidelity to the source document and strict regulatory compliance.

This requirement applies alongside French linguistic conventions and standards, which are not overridden by source language compliance. For example, French typographical rules, such as punctuation, capitalization, non-breaking spaces, non-breaking hyphens, and decimal commas where required, are regulatory standards rather than mere stylistic preferences.

In addition to the templates with standardized wording, the French official versions of regulatory dictionaries and databases for the relevant sections of SmPC must be used. These include EDQM Standard Terms for pharmaceutical forms, routes of administration and packaging materials, MedDRA for coding and classification of adverse events, anatomical therapeutic chemical (ATC) classification system for international nonproprietary name (INN) and pharmacotherapeutic group, SMS within the EMA’s SPOR platform to verify active substances and excipients, including those used in investigational medicinal products, as well as the EMA Excipients Guideline, which serves as the official multilingual reference for excipient names, corresponding E-numbers and related warnings. These references are not limited to SmPC but apply more broadly to other regulatory documents.

3. Consistency And Terminology In Regulatory Medical Writing

Consistency is a core requirement in regulatory writing and represents a major source of regulatory risk when not adequately managed. In the context of translation, inconsistencies in the source document are a common cause of inconsistencies in the target document, especially when a client glossary must be strictly followed.

The same concept must always be expressed with a single validated term within a regulatory document. For example, terms such as IMP, study drug, and study treatment should consistently be translated into the only official term "médicament expérimental" in French regulatory documents intended for healthcare professionals. Other typical examples of terminological inconsistencies include alternating between "patient," "sujet," and "participant" within the same document. While French current regulatory terminology favors "participant" as an inclusive and ethically neutral term in clinical trial documentation, "patient" remains the preferred term in SmPC, except in fixed phrasings such as "sujets âgés."

Terminological consistency must also be maintained across all related documents. The PI package (SmPC/PL/Labeling) constitutes a single regulatory set. Core elements must be strictly aligned across all components, including ATC classification, substance names such as INN and excipients, units, therapeutic indications, and EDQM Standard Terms. While the regulatory content must remain consistent, terminology and level of technicality must be tailored to the intended audience. Failure to make this terminology adaptation may lead to oversimplified professional documentation or overly technical patient-facing materials.

Consistency extends outside the PI to all documents related to a clinical trial, including protocols, statistical analysis plan (SAP), clinical study report (CSR), and investigator’s brochure (IB). Disease names and endpoints with key definitions must remain strictly identical across documentation. When multiple French denominations exist or when clarification is needed, reference to authoritative resources, such as the WHO ICD and the "Dictionnaire de l’Académie de médecine," help ensure precise medical concepts.

Additionally, regulatory writing requires neutral, descriptive, and measurable formulations. Promotional language, subjective qualifiers, and stylistic embellishments should be excluded. Literary, superfluous, or narrative constructions and wording should be avoided as well.

Finally, medical terminology and regulatory writing practices evolve, and this evolution should not be overlooked. While standardized wording in approved SmPC must be preserved, outdated terms and obsolete denominations should be avoided. Preference should be given to current regulatory and medical usage, including Terminologia Anatomica terminology where applicable, ensuring long-term regulatory consistency.

4. Management Of Calques And Anglicisms

Ensuring accuracy and fidelity to the source document is essential for maintaining conceptual equivalence. Nevertheless, accuracy must never compromise clinical readability. Medical French is a discipline in its own right and cannot be reduced to an Anglicized derivative of English regulatory phrasing. A French SmPC may be fully QRD-compliant and still remain non-idiomatic, overly literal, or contain hidden anglicisms. Balancing regulatory compliance with clinical readability is a core challenge of modern regulatory writing. Health authorities require precision, terminological consistency, and absence of ambiguity, not the mechanical transfer of English phrasing or calques.

Anglicisms are acceptable only if they are deeply entrenched in regulatory usage or explicitly required by a normative framework. Otherwise, calques can impoverish French, reduce linguistic flexibility, and blur clinical meaning.

Additionally, particular attention must be paid to terminological localization. Certain anglicisms widely accepted in Canadian French may be inappropriate or confusing for other French healthcare professionals. Examples commonly encountered in regulatory documents include "niveau" instead of "taux" or "concentrations plasmatiques," or "formule sanguine complète" instead of "numération formule sanguine."

Even when such calques are common, they should not be normalized without critical assessment. From an operational standpoint, anglicisms can be grouped into three categories:

• Anglicisms to be retained, either because they are imposed by regulatory usage or applicable normative frameworks (e.g., fixed QRD wording, MedDRA terminology where required) or because they are easily recognized French by healthcare professionals, such as some English abbreviations (e.g., CRF – case report form, INR – international normalized ratio).
• Anglicisms to be avoided, especially those linguistically incorrect or scientifically misleading (e.g., "supporter" instead of "étayer" or "corroborer;" or "dommage" instead of "atteinte," "altération" or "dégradation," depending on context).
• Anglicisms commonly used in clinical practice and considered "tolerated," for which French alternatives are preferable. For example, "développer une réaction ou des symptômes" may be replaced by the more linguistically precise expressions "présenter des symptômes" or "manifester une réaction." Similarly, "maladie non contrôlée" and "efficacité altérée" are more appropriately rendered as "maladie non stabilisée" and "efficacité diminuée."

It is also crucial to use idiomatic phrasing, avoiding constructions too close to English that may result in unnatural medical French (e.g., "réduction progressive de la dose" rather than "graduelle," "réduire le risque" rather than "minimiser").

The rule is simple: Whenever it is possible to replace an anglicism with its French equivalent, and it is fully comprehensible by healthcare professionals, the French term must be preferred.

Finally, regulatory medical writing should follow the recommendations of "Académie de médecine" and French linguistic authorities. However, where a divergence exists between these recommendations and the terminology used in official regulatory documentation by health authorities, and consistently applied in French-speaking clinical practice, priority should be given to the latter in operational documents, provided that the term is neither scientifically imprecise nor misleading. This context-driven and operationally grounded approach preserves clarity, readability, and regulatory consistency.

Conclusion

Even when all regulatory requirements are formally met, documentation may still fall short, not scientifically but linguistically. QRD compliance is often assumed to guarantee clarity and clinical usability, yet this assumption does not always hold true. Regulatory standards provide a nonnegotiable foundation, but they do not prevent ambiguous, awkward, or linguistically inappropriate phrasings. A French SmPC may fully comply with QRD requirements, implement EDQM terminology, and reference regulatory dictionaries correctly, while still creating confusion in clinical practice.

At this point, regulatory translation transcends linguistic transfer and becomes a form of linguistic risk management. True quality is achieved only when regulatory compliance, terminology precision, and clinical readability are aligned, a balance that is demanding but entirely achievable.

Uncritical adherence to predefined glossaries is insufficient when medical context, target audience, or regulatory framework are not fully considered. Inconsistencies in the source text inevitably carry over into the target document, affecting both consistency and credibility. Nevertheless, glossaries remain essential tools when used with contextual awareness and scientific judgement.

Ultimately, the core challenge lies in ensuring strict regulatory compliance while maintaining clinical readability and avoiding literal translation. In submissions to European authorities, terminology precision is essential for credibility and safety. Regulatory French is a discipline in its own right and treating it as such is what makes submissions clearer, safer, and more reliable.

Author's Note:

A more detailed and technical version of this analysis, including extended terminology examples and additional regulatory  considerations, is available on the author's website. This extended version also includes a dedicated section addressing commonly misinterpreted terms in English-to-French regulatory translation. This section was intentionally excluded from the published article to meet editorial format and length constraints.

The full article is available here: https://meditranslat.fr/en/insights-publications/General-introduction-From-Pharmacy-to-Medical-Translation-and-Writing-A-Healthcare-Professionals-Perspective-on-Terminology.

About The Author:

Farah Ayadi is a medical-linguistic consultant, PharmD, and certified medical translator. She combines clinical expertise with hands-on experience in medical and regulatory translation, review, and content analysis. She specializes in medical terminology, linguistic risk management, and French medical writing advisory, focusing both on regulatory compliance and audience-tailored terminology, supporting safety, consistency, and credibility of documentation.

A National University of Ireland alumnus, and a dual French-Irish national, Stephen O’Sullivan is a Paris-based linguist working in English, French, and Spanish. Having worked in the medical and pharmaceutical fields for several decades he has wide experience of regulatory affairs documentation.