top of page

What is MedDRA?

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

  • Investigators’ Brochures

  • Core Company Safety Information

  • Marketing Applications

  • Publications

  • Prescribing Information

  • Advertising

MedDRA is not a dictionary about devices, drugs, equipment, or diagnostic products. It does NOT contain:

  • Clinical trial study design terms

  • Frequency qualifiers

  • Numerical values for results

  • Patient demographic terms

  • Severity descriptors

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:

  • Medical conditions

  • Indications

  • Investigations (tests, results)

  • Medical + surgical procedures

  • Medication errors

  • Product quality issues

  • Device-related issues

  • Product use issues

  • Pharmacogenetic terms

  • Toxicologic 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!


Thank you for subscribing!

bottom of page