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Medical Dictionary for Regulatory Activities - MedDRA

Database of Adverse Event Notifications

20 July 2016

The Medical Dictionary for Regulatory Activities (MedDRA) is an internationally used set of terms relating to medical conditions, medicines and medical devices.

It was created to assist regulators with sharing information. It is also used by industry, academics, health professionals and other organisations that communicate medical information.

MedDRA terms in the Database of Adverse Event Notifications - medicines

The TGA uses MedDRA terms for coding the reports it receives about adverse events.

Before a report is entered into the Database of Adverse Event Notifications - medicines, the relevant MedDRA terms are assigned to describe the adverse event and other medical terms as necessary. This results in a consistent terminology, which enables related adverse events in DAEN - medicines to be grouped together in the medicine summary.

MedDRA terms

MedDRA includes standardised terms for:

  • symptoms, signs, diseases, syndromes and diagnoses
  • medical device malfunctions
  • medication errors
  • medical, social and family history information
  • sites (e.g. application, implant and injection sites)
  • medical and surgical procedures
  • approved uses for medications and medical devices
  • types of investigations (e.g. liver function analyses, metabolism tests).

MedDRA system organ classes

The MedDRA system organ class is defined as the highest level of the MedDRA terminology, distinguished by anatomical or physiological system, aetiology (disease origin) or purpose. Most of these describe disorders of a specific part of the body. For example:

  • Cardiac disorders describe heart problems
  • Renal and urinary disorders describe kidney and bladder problems
  • Some of the system organ classes are not related to a particular part of the body. For example:
    • investigations describes laboratory tests and other medical investigations that gave an unusual reading
    • neoplasms describes any type of growth, including cancer, no matter where it appears in the body.

The 27 MedDRA system organ classes

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  1. Blood and lymphatic system disorders
  2. Cardiac disorders
  3. Congenital, familial and genetic disorders
  4. Ear and labyrinth disorders
  5. Endocrine disorders
  6. Eye disorders
  7. Gastrointestinal disorders
  8. General disorders and administration site conditions
  9. Hepatobiliary disorders
  10. Immune system disorders
  11. Infections and infestations
  12. Injury, poisoning and procedural complications
  13. Investigations
  14. Metabolism and nutrition disorders
  15. Musculoskeletal and connective tissue disorders
  16. Neoplasms benign, malignant and unspecified (incl cysts and polyps)
  17. Nervous system disorders
  18. Pregnancy, puerperium and perinatal conditions
  19. Psychiatric disorders
  20. Renal and urinary disorders
  21. Reproductive system and breast disorders
  22. Respiratory, thoracic and mediastinal disorders
  23. Skin and subcutaneous tissue disorders
  24. Social circumstances
  25. Surgical and medical procedures
  26. Vascular disorders
  27. Product issues.

MedDRA reaction terms

The term used to describe an adverse event in the Database of Adverse Event Notifications - medicines is the MedDRA 'preferred term', which describes a single medical concept.

Each MedDRA system organ class has a number of MedDRA preferred terms associated with it. For example, the system organ class 'cardiac disorders' includes (among others) the following preferred terms:

  • angina
  • cardiac arrest
  • myocardial infarction
  • palpitations.

The MedDRA Maintenance and Support Services Organization

The MedDRA Maintenance and Support Services Organization (MSSO) maintains and distributes MedDRA information. The MSSO releases updated versions of MedDRA twice a year to subscribers.

MedDRA was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to assist regulatory authorities to easily and accurately share information on therapeutic goods, including about adverse events to medicines.

MedDRA terminology incorporates terminology from the:

  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • World Health Organization Adverse Reaction Terminology (WHO-ART)
  • International Classification of Diseases (ICD)
  • International Classification of Diseases and Clinical Modification (ICD-CM)
  • Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)
  • Japanese Adverse Reaction Terminology (J-ART).