Meddra

The Medical Dictionary for Regulatory Activities, MedDRA for short, is a comprehensive collection of highly specific standardised medical terms used in a wide range of regulatory processes related to drug approval. MedDRA was developed under the leadership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to facilitate the international exchange of regulatory information for medical devices used by humans. All assessments are uniformly defined.

MedDRA is used for registration, documentation and safety monitoring of medical devices before and after a product is approved for sale. MedDRA is used for studies with pharmaceuticals, biologicals, vaccines and medical devices. MedDRA is also used for coding in clinical studies. The coding results in an 8-digit numeric code.

In the EU and USA, the coding of adverse events according to MedDRA terminology is mandatory for electronic transmission to the competent authorities. The preparation of the summary of product characteristics (package leaflet) is also carried out according to MedDRA terminology.

The terms unified by MedDRA include names for clinical signs, symptoms, diseases, diagnoses, therapeutic indications, medication errors, product quality, surgical and medical procedures and various anamnestic characteristics.

MedDRA also standardises terms for clinical signs, symptoms, diseases, diagnoses, therapeutic indications, medication error and product quality terms, surgical and medical procedures and various anamnestic features.

Also names and qualitative and quantitative results of investigations such as:

increased, decreased, normal, abnormal, detectable, undetectable, positive and negative

or very frequently: > 1 in 10, frequently: > 1 in 100, occasionally: > 1 in 1000, rarely: > 1 in 10 000, very rarely: < 1 in 10 000.

are used in a standardized way.

Furthermore, the terms in MedDRA are assigned to twenty-seven organ and disease classes (SOC) at the highest hierarchical level:

1.infections and parasitic diseases

2.benign, malignant and non-specific neoplasms (including cysts and polyps)

3.diseases of the blood and lymphatic system

4.diseases of the immune system

5.endocrine diseases

6.metabolic and nutritional disorders

7.psychiatric diseases

8. diseases of the nervous system

9.eye diseases

10.diseases of the ear and the labyrinth

11.heart diseases

12.vascular diseases

13. diseases of the respiratory tract, chest and mediastinum

14.diseases of the gastrointestinal tract

15.liver and bile diseases

16.diseases of the skin and subcutaneous tissue

17. diseases of skeletal muscles, connective tissue and bones

18. diseases of the kidneys and urinary tract

19. pregnancy, postpartum and perinatal diseases

20. diseases of the genital organs and the mammary gland

21.congenital, familial and genetic diseases

22.general illnesses and complaints at the place of administration

23.examinations

24.injury, poisoning and complications caused by surgery

25.surgical and medical interventions

26.social circumstances

27.product problems

After the highest level, the system organ class (SOC), comes the group name of the high level, followed by the name of the high level, the preferred name and the name of the lowest level. The lowest level contains 66,000 terms. Other terminologies such as COSTART (Coding Symbols for Thesaurus od Adverse Reaction Terms), ICD-9 (International Classification of Diseases), J-Art (Japanese Adverse Reaction Terminology) and WHO-Art (WHO Adverse Reaction Terminology) have been incorporated into the terms.

MedDRA is open to anyone who wants to use it, although when it was first implemented in 1999, most users were located in Europe, Japan and the USA. Increasing use worldwide by regulators, global pharmaceutical companies, clinical research institutions and health professionals today enables better global protection of patient health.