Medical Dictionary for Regulatory Activities

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The Medical Dictionary for Regulatory Activities (German: Medical dictionary for activities in the context of drug approval ), abbreviated to MedDRA , is a collection of standardized, primarily medical terms that are used in a wide variety of regulatory processes relating to drug approval . MedDRA was developed under the leadership of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The focus was on creating a basis for internationally standardized communication between licensing authorities and pharmaceutical companies as well as automated data transmission.

The terms standardized and coded by MedDRA include terms for clinical signs, symptoms , diseases, diagnoses , therapeutic indications , medication error and product quality terms , surgical and medical interventions and various anamnestic characteristics. The names and qualitative results of studies, e.g. B. increased, decreased, normal, abnormal, detectable, undetectable, positive and negative are defined by MedDRA.

MedDRA ® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is sold and serviced through the Maintenance and Support Services Organization (MSSO). The MSSO publishes updates every six months .

meaning

MedDRA is important for the uniform classification of adverse drug events and adverse drug effects (side effects) both in the pre- and post-marketing phase of finished drugs ( clinical studies of all phases, pharmacovigilance ) as well as for their electronic recording and further processing. In the EU and the US , encryption of adverse events is required according to MedDRA terminology for electronic transmission to the relevant authorities. The use of MedDRA terminology is also required in the compilation of the product characteristics ( summary of product characteristics ).

structure

The MedDRA term collection is structured hierarchically. It comprises over 78,000 designations (so-called terms ) on the lowest level , which are brought together in 27 systematic classifications on the top level via various levels and paths. These classes at the top level form the organ class system ( System Organ Class , SOC). Each level is characterized by a certain granularity .

hierarchy

The MedDRA terms are arranged hierarchically on five levels:

System Organ Class (SOC)
system organ class
↓
High Level Group Term (HLGT)
group designation of the high level
↓
High Level Term (HLT) Term for
the high level
↓
Preferred Term (PT)
Preferred term
↓
Lowest Level Term (LLT)
Designation of the lowest level

Terms

When creating MedDRA, terms from various existing terminologies such as Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART), International Classification of Diseases, Ninth Revision (ICD-9), Japanese Adverse Reaction Terminology (J-ART), WHO Adverse Reaction Terminology (WHO-ART) and Hoechst Adverse Reaction Terminology System (HARTS) have also been incorporated. The semi-annual updates take into account new and deleted terms. There are also rearrangements of terms with regard to the higher level.

Organ classes

The terms in MedDRA are assigned to twenty-seven organ classes at the highest hierarchical level:

  1. Infections and Parasitic Diseases
  2. Neoplasms benign, malignant, and unspecified (including cysts and polyps )
  3. Blood and lymphatic system disorders
  4. Immune system disorders
  5. Endocrine Disorders
  6. Metabolism and nutrition disorders
  7. Psychiatric illness
  8. Nervous system disorders
  9. Eye diseases
  10. Diseases of the ear and labyrinth
  11. Heart disease
  12. Vascular disease
  13. Respiratory , thoracic and mediastinal disorders
  14. Gastrointestinal disorders
  15. Liver and biliary diseases
  16. Skin and subcutaneous tissue disorders
  17. Musculoskeletal , connective tissue and bone diseases
  18. Diseases of the kidney and urinary tract
  19. Pregnancy , the puerperium and perinatal diseases
  20. Diseases of the genital organs and the mammary gland
  21. Congenital , familial and genetic diseases
  22. General disorders and administration site conditions
  23. Investigations
  24. Injury, poisoning, and procedural complications
  25. Surgical and medical interventions
  26. Social circumstances
  27. Product problems

Coding

The coding, i.e. H. the selection of terms and the assignment within the levels and along the paths is computer-aided and based on complex rules. Each term is encrypted using an 8-digit numeric code.

Research

The Standardized MedDRA Query (SMQ) tool is available for database queries . The structure of MedDRA allows the comparability of adverse drug reactions, their addition and the summary along defined paths.

Japan

In addition to the conventional MedDRA version, there is also a Japanese version called MedDRA / J. This is maintained by the Japanese counterpart to the MSSO, the so-called Japanese Maintenance Organization (JMO), in order to meet the requirements of the national Ministry of Health, Labor and Social Affairs (MHLW).

Individual evidence

  1. ^ MedDRA Japanese Maintenance Organization
  2. ↑ MHLW Notification on MedDRA ( Memento from September 21, 2008 in the Internet Archive )

Web links