MedDRA, short for the Medical Dictionary for Regulatory Activities, is a clinically validated international medical terminology. It’s like the universal language of the medical world, helping everyone from doctors to researchers speak the same language when it comes to medical terms.
Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA is used by regulatory authorities and the biopharmaceutical industry. It’s like a bridge that connects different stakeholders in the medical field, ensuring everyone is on the same page.
The terminology is used throughout the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. Think of it as the backbone of the medical regulatory process, supporting every stage with its comprehensive terminology.
But what makes MedDRA so special? Why is it the chosen terminology for such a critical industry? Well, it’s all about its structure and organization. MedDRA is organized in a hierarchical structure, which means terms are arranged from very specific to very general. This allows for flexibility and precision in coding and reporting.