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Part 1: General Regulatory Principles

 

In regulatory medical writing, some rules apply universally to all regulatory documents, regardless of language, while others are language-specific and rely on defined linguistic features (i.e. French in this article). Distinguishing between these two layers is essential to avoid both formal non-compliance and subtle terminological inconsistencies.

 

Compliance with Regulatory Templates and Requirements

 

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 SmPC.
For centralized procedures, the most recent and up-to-date Quality Review of Documents (QRD) templates must be fully applied, together with all associated annexes and appendices, without any adjustment or deviation. Compliance with templates also applies to national authorization, decentralized and mutual recognition procedures (NAT/DCP/MRP), for which national templates approved by regulatory authorities must be followed: for French dossiers, this requires the T10 templates of the French health authority "Agence nationale de sécurité du médicament et des produits de santé" (ANSM).
Apart from templates, compliance with additional regulatory requirements is equally mandatory. These include authorized abbreviations, excipient guidelines, formatting rules, stylistic conventions and QRD decisions on the use of certain terms. Failure to comply with any of these requirements may result in regulatory queries, even when the scientific content itself is correct.

 

Translation Considerations and Identifying Potential Issues

Although certain European Medicines Agency (EMA) terminological recommendations primarily target English, they can be used for identifying and flagging non-compliance in the source documents in a translation context. 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 rather than EKG, or C_max instead of Cmax.
These recommendations can also be used to extrapolate certain terminological and conceptual principles into French in sensitive regulatory contexts, typically with regard to the age-related terminology and classification of pediatric population. For example, just as the English expression young children is not recommended due to its lack of precision, the French equivalent "jeunes enfants" should likewise be avoided. According to EMA definitions, the pediatric population is clearly categorized into newborn infants (from birth to 27 days), infants and toddlers (28 days to 23 months), children (2 to 11 years) and adolescents. It is worth noting that although the term toddler has a distinct meaning in general English usage, this concept does not exist in QRD terminology. In EMA regulatory guidance, infants and toddlers are often grouped together, and should therefore be translated into French as "nourrissons" when referring to patients/subjects aged 28 days to 23 months.
Similar principles apply to other terminological choices, such as the use of "glucose" rather than "dextrose", or avoiding "VIH+" and "VIH-", for which "séropositif au VIH" and "séronégatif au VIH" are more appropriate.
In a translation context (i.e. from English into French in this article), issues or errors in the source document should never be transferred mechanically into the target text. Potential regulatory queries should be anticipated and any uncertainty should be addressed with care and transparency. When a terminological inconsistency or any non-compliance is identified, it should be flagged, with a clear recommendation for the appropriate term or phrasing in the target document. Commonly occurring issues include:

• Expressing the same concept using multiple terms. Regarding terminological consistency, the rule is simple: for the same concept, a single validated term should be considered and used consistently throughout the source and target documents. For example, clinical trial is the recommended term in English according to the EMA Glossary of Regulatory Terms, and in French, "essai clinique" is the term listed in the ANSM clinical trials glossary. Of course, clinial study and "étude clinique" are also correct, but consistency is key (for additional examples of terminological inconsistencies, see Section 3).

• Not writing the International Nonproprietary Name (INN) in lower case (outside the beginning of a sentence).

• Inconsistent formatting of the invented/brand name (e.g. variations in case or font), or unnecessary highlighting or repetition.

• Use of a non-official excipient name or a non-compliant E-number (even though some E-numbers are authorized outside the official list).

These examples illustrate why regulatory translation must go beyond mere linguistic equivalence.

 

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