Navigating MedDRA Terminology in Medical Translation

In the intricate world of medical translation, precision and accuracy are paramount. This becomes particularly evident in the translation of MedDRA terminology. MedDRA, the Medical Dictionary for Regulatory Activities, plays a pivotal role in the global pharmacovigilance landscape. It serves as the lingua franca for adverse event reporting, ensuring that safety data is standardized and comprehensible across borders. 

What is MedDRA terminology?

MedDRA is not just another medical glossary. It’s a comprehensive, globally recognized dictionary specifically designed for regulatory activities within the life sciences industry. Its primary function is to facilitate the uniform classification of medical terminology related to adverse events associated with pharmaceuticals, biologics, vaccines, and medical devices. In simpler terms, it’s the backbone of safety data analysis for the pharmaceutical and healthcare sectors.

The structure of MedDRA is organized into a system of five levels: 

• Lowest Level Term (LLT): reflects how information is communicated or how an observation is reported in practice. 
• Preferred Term (PT): single concepts for symptoms, signs, disease diagnoses, therapeutic indications, investigations, surgical or medical procedures, and medical, social or family history characteristics.  
• High Level Term (HLT): Related Preferred Terms (PTs) grouped together, based on anatomy, pathology, physiology, etiology, or function.
• High Level Group Term (HLGT): Related High Level Terms (HLTs) grouped together.
• System Organ Class (SOC): Related High Level Group Terms (HLGTs) grouped together, based on etiology, manifestation site, or purpose.

Why should medical translators adhere to MedDRA terminology? 

The answer lies in patient safety. When adverse events are reported, they need to be understood and analyzed swiftly and accurately. This understanding is crucial not only for regulatory compliance but, more importantly, for ensuring the well-being of patients. Accurate translation of MedDRA terms helps maintain the integrity of safety data, which in turn supports informed decision-making in the healthcare field.

Moreover, MedDRA was introduced as a collaborative terminology standardization project, meant to eliminate the use of different terminologies through the different stages of the development of medicines.

Keep reading!

At Win & Winnow, we specialize in providing accurate and contextually sensitive translations for the life sciences industry, including the precise translation of MedDRA terminology. If you’re in need of expert translation services that prioritize accuracy and compliance, contact us today to explore how we can support your global pharmacovigilance efforts.