Part 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 cannot 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 phrasings take precedence over the source document. Any deviation or issue must be systematically flagged as detailed in the previous section.
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 addressed separately and are not overridden by source-language compliance. For example, French typographical rules are equally mandatory regardless of the source document. These include the correct use of punctuation and capitalization, non-breaking spaces where appropriate (e.g. before units of measurement or thousands), non-breaking hyphens for numerical ranges and the use of decimal commas in French. These conventions 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:
EDQM (European Directorate for the Quality of Medicines) Standard Terms: for pharmaceutical forms, routes of administration and packaging materials across all sections.
MedDRA (Medical Dictionary for Regulatory Activities): particularly section 4.8 undesirable effects of the SmPC. Adverse events must be coded using Preferred Terms (PT) and classified by System Organ Classes (SOC).
The ATC (Anatomical Therapeutic Chemical) classification system: for INN and pharmacotherapeutic group.
The EMA Excipients Guideline Excel table, which serves as the official reference in all languages. This resource is used not only for standard warnings in the Package Leaflets (PL) but also to provide guidance for SmPC warnings, including verification of official excipient names and E-numbers.
SMS (Substance Management Services within the EMA’s SPOR platform): can be used to verify excipient names and active substances, including those used in investigational medicinal products (IMP).
Some of these references are also essential in translating other regulatory documents. For example, the French official versions of active substances and excipients must always be used, and MedDRA coding (French official version) is also applied in pharmacovigilance documentation.
