Medical Dictionary for Regulatory Activities
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 |
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High Level Group Term (HLGT) group designation of the high level |
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High Level Term (HLT) Term for the high level |
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Preferred Term (PT) Preferred term |
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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:
- Infections and Parasitic Diseases
- Neoplasms benign, malignant, and unspecified (including cysts and polyps )
- Blood and lymphatic system disorders
- Immune system disorders
- Endocrine Disorders
- Metabolism and nutrition disorders
- Psychiatric illness
- Nervous system disorders
- Eye diseases
- Diseases of the ear and labyrinth
- Heart disease
- Vascular disease
- Respiratory , thoracic and mediastinal disorders
- Gastrointestinal disorders
- Liver and biliary diseases
- Skin and subcutaneous tissue disorders
- Musculoskeletal , connective tissue and bone diseases
- Diseases of the kidney and urinary tract
- Pregnancy , the puerperium and perinatal diseases
- Diseases of the genital organs and the mammary gland
- Congenital , familial and genetic diseases
- General disorders and administration site conditions
- Investigations
- Injury, poisoning, and procedural complications
- Surgical and medical interventions
- Social circumstances
- 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
- ^ MedDRA Japanese Maintenance Organization
- ↑ MHLW Notification on MedDRA ( Memento from September 21, 2008 in the Internet Archive )
Web links
- MedDRA on the website of I (English)
- MedDRA MSSO (English)
- The Roles of the MSSO and the JMO , Lecture 2001.