MedDRA stands for Medical Dictionary for Regulatory Activities and is owned by ICH — the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
It facilitates the exchange of clinical information through standardization.
MedDRA is a clinically validated international medical terminology used by regulatory authorities and the biopharmaceutical industry. That terminology is used throughout the whole regulatory process (from pre-marketing to post-marketing) and for data entry, retrieval, evaluation, and presentation.
Where is MedDRA used?
MedDRA is used in:
Regulatory Authority and Industry Databases
Individual Case Safety Reports and Safety Summaries
Clinical Summary Reports
Core Company Safety Information
MedDRA is not a dictionary about devices, drugs, equipment, or diagnostic products. It does NOT contain:
Clinical trial study design terms
Numerical values for results
Patient demographic terms
How is MedDRA structured?
MedDRA is structured in five levels:
System Organ Class (SOC)
High-Level Group Term (HLGT)
High-Level Term (HLT)
Preferred Term (PT)
Lowest-Level Term (LLT)
Each MedDRA term is assigned an 8-digit numeric code. A code can fulfill a data field in various electronic submission types.
The scope of MedDRA includes:
Investigations (tests, results)
Medical + surgical procedures
Product quality issues
Product use issues
How do you access MedDRA?
MedDRA may or may not be free, depending on the type of subscription. Members of TREMÉDICA, for instance, have access to MedDRA.
If you need a medical translator (into Spanish or Catalan) or a medical writer (in English), feel free to contact me!