Ten years of experience in the biomedical translation industry have undoubtedly led me to use several resources to aid in producing regulatory-compliant translations for the pharmaceutical translation industry.
Below I’m sharing some of the websites and tools that I use on a daily basis. starting with terminology databases:
Cosnautas
A web-based platform providing access to a catalog of medical dictionaries and glossaries for anyone working with Spanish, English, German, and Portuguese medical and pharmaceutical terminology.
Among the variety of resources offered in this essential website, I consider the following to be essential for anyone performing biomedical translations in the English-Spanish combination:
- Libro Rojo: a bilingual English-Spanish glossary of the medical and pharmaceutical terminology, including exhaustive explanations on potential false friends.
- Siglas médicas en español: a compilation of medical acronyms and abbreviations commonly used in Spain, with their corresponding translations into English.
- Diccionario inglés-español de investigación clínica: an English-Spanish dictionary focusing on the field of clinical research.
- Alergología e inmunología: an English-Spanish dictionary specifically tailored for the fields of allergology and immunology
Diccionario de Términos Médicos
The Diccionario de Términos Médicos (DTM) is a comprehensive dictionary of medical terms published by the Royal National Academy of Medicine (RANM, Real Academia Nacional de Medicina) that contains detailed definitions of specialized medical terms, together with their synonyms and translations into English.
Medical Dictionary for Regulatory Activities
MedDRA is a terminological database compiled by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) that compiles standardized and clinically validated international medical terminology.
Among others, the database covers medical conditions, indications, medical procedures, device‑related issues, and toxicologic issues, but not terms specifically referring to medical devices or drugs.
These terms are structured into five levels:
- System Organ Class (SOC): the highest classification based on anatomical or physiological system, disease etiology or purpose.
- High-Level Group Term (HLGT): a superordinate descriptor for high level terms related by anatomy, pathology, physiology, etiology, or function.
- High‑Level Term (HLT): an inclusive category that links preferred terms by anatomy, pathology, physiology, etiology, or function.
- Preferred Term (PT): the most unambiguous, specific, and self-descriptive term available to refer to symptom, sign, disease, diagnostic, therapeutic indication, surgical or medical procedure, or history characteristic.
- Lowest Level Term (LLT): the colloquial synonym, lexical variant, or sub-element of a preferred term.
Its use is mandatory in several documents of the regulatory process, from drug pre-marketing to post-marketing, such as in the reporting of adverse events in clinical trials and pharmacovigilance reports, in regulatory submissions to health authorities, clinical summary reports, and sections of summary of product characteristic.
Reach out to me if you need help translating highly specialized documents requiring the use of any of these resources.
