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Medical Dictionary for Regulatory Activities Terminology

Abbreviation: MedDRA

General Information

MedDRA is a multilingual terminology allowing most users to operate in their native languages. MedDRA can be used to analyse individual medical events (e.g., “Influenza”) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multi-axial hierarchy or through the special feature of Standardised MedDRA Queries. The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).

This record replaces or incorporates the following deprecated resources:

Coding Symbols for a Thesaurus of Adverse Reaction Terms

Homepage http://www.meddra.org/

Countries that developed this resource United States

Created in 1993

Taxonomic range

Homo sapiens

Knowledge Domains

Subjects

How to cite this record FAIRsharing.org: MedDRA; Medical Dictionary for Regulatory Activities Terminology; DOI: https://doi.org/10.25504/FAIRsharing.ad3137; Last edited: June 27, 2019, 2 p.m.; Last accessed: Sep 23 2020 1:38 p.m.

This record is maintained by MedDRAMSSO

Record updated: June 27, 2019, 2 p.m. by The FAIRsharing Team.

Show edit history

Edits to 'https://fairsharing.org/FAIRsharing.ad3137' by 'The FAIRsharing Team' at 14:00, 27 Jun 2019 (not approved):

	'contact' has been modified:
		Before: 
		After: None

Edits to 'https://fairsharing.org/FAIRsharing.ad3137' by 'The FAIRsharing Team' at 13:31, 14 Jun 2019 (approved):

'description' has been modified:
Before: MedDRA is a multilingual terminology allowing most users to operate in their native languages. The most important reason to ?code? data into a standardised terminology is to analyse it. A key benefit of MedDRA is in its support of straightforward as well as sophisticated analyses. MedDRA can be used to analyse individual medical events (e.g., ?Influenza?) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multiaxial hierarchy or through the special feature of Standardised MedDRA Queries.

The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).
After: MedDRA is a multilingual terminology allowing most users to operate in their native languages. MedDRA can be used to analyse individual medical events (e.g., ?Influenza?) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multi-axial hierarchy or through the special feature of Standardised MedDRA Queries.

The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).

Edits to 'https://fairsharing.org/FAIRsharing.ad3137' by 'The FAIRsharing Team' at 09:29, 05 May 2019 (approved):

	'supportLinks' has been modified:
		Before:
			FAQ|http://www.meddra.org/faq
			contact form|http://www.meddra.org/contact
			online documentation|http://www.meddra.org/how-to-use/basics/hierarchy
			online documentation|http://www.meddra.org/how-to-use/support-documentation
			rss|https://www.meddra.org/rss
			training|http://www.meddra.org/training/offerings
		After:
			FAQ|http://www.meddra.org/faq
			blog|https://www.meddra.org/news-and-events/news
			contact form|http://www.meddra.org/contact
			online documentation|http://www.meddra.org/how-to-use/support-documentation
			online documentation|http://www.meddra.org/how-to-use/basics/hierarchy
			rss|https://www.meddra.org/rss
			training|http://www.meddra.org/training/offerings
		Added:
			blog|https://www.meddra.org/news-and-events/news
		Removed:

Edits to 'https://fairsharing.org/FAIRsharing.ad3137' by 'The FAIRsharing Team' at 09:28, 05 May 2019 (approved):

	'onto_disciplines' has been modified:
		Before:
			Biomedical Science
			Medicine
			Preclinical and Clinical Studies
		After:
			Biomedical Science
			Medicine
			Ontology and Terminology
			Preclinical and Clinical Studies
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			Ontology and Terminology
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	'related_standards' has been modified:
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			Investigation Study Assay Tabular
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			Investigation Study Assay Tabular
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	'supportLinks' has been modified:
		Before:
			FAQ|http://www.meddra.org/faq
			contact form|http://www.meddra.org/contact
			online documentation|http://www.meddra.org/how-to-use/basics/hierarchy
			online documentation|http://www.meddra.org/how-to-use/support-documentation
			training|http://www.meddra.org/training/offerings
		After:
			FAQ|http://www.meddra.org/faq
			contact form|http://www.meddra.org/contact
			online documentation|http://www.meddra.org/how-to-use/basics/hierarchy
			online documentation|http://www.meddra.org/how-to-use/support-documentation
			rss|https://www.meddra.org/rss
			training|http://www.meddra.org/training/offerings
		Added:
			rss|https://www.meddra.org/rss
		Removed:

	'publications' has been modified:
		Before:
			The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).|Yokotsuka M,Aoyama M,Kubota K|Int J Med Inform|2000
		After:
			The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).|Yokotsuka M,Aoyama M,Kubota K|Int J Med Inform|2000
			The medical dictionary for regulatory activities (MedDRA).|Brown EG,Wood L,Wood S|Drug Saf|1999
		Added:
			The medical dictionary for regulatory activities (MedDRA).|Brown EG,Wood L,Wood S|Drug Saf|1999
		Removed:

In Collections

RDA Covid-19 WG Resources

eTRIKS Standards Starter Pack

Support

General

FAQ	http://www.meddra.org/faq
blog	News
contact form	http://www.meddra.org/contact
online documentation	http://www.meddra.org/how-to-use/support ...
online documentation	http://www.meddra.org/how-to-use/basics/ ...
rss	RSS
training	http://www.meddra.org/training/offerings

Additional Information

Contact

None

External Links

Bioportal

http://bioportal.bioontology.org/ontologies/MEDDRA

Tools

Standardised MedDRA Queries	http://www.meddra.org/how-to-use/tools/smqs
MedDRA Version Analysis Tool	https://tools.meddra.org/mvat/

Schemas

No XSD schemas defined

Access / Retrieve Data

Conditions of Use

Applies to: Data use

MedDRA Special Licence

Data Access

browse

https://tools.meddra.org/wbb/

Publications

The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

Yokotsuka M,Aoyama M,Kubota K
Int J Med Inform 2000

View Paper (PubMed)

The medical dictionary for regulatory activities (MedDRA).

Brown EG,Wood L,Wood S
Drug Saf 1999

View Paper (PubMed) View Publication

MEDDRA Ontology Display

View in BioPortal.

Disclaimer: This widget assumes the availability of the ontology resources in the NCBO BioPortal.

Related Standards

Reporting Guidelines

No guidelines defined

Terminology Artifacts

No semantic standards defined

Models and Formats

Investigation Study Assay Tabular

Identifier Schemas

No identifier schema standards defined

Metrics

No metrics standards defined

Related Databases (6)

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European Union Drug Regulating Authorities Clinical Trials
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC.

Disbiome
Disbiome is a database covering microbial composition changes in different kinds of diseases. Disease names, detection methods or organism names can be used as search queries giving that return information related to the experiment (related disease/bacteria, abundancy subject/control, control type, detection method and related literature).

VigiBase
VigiBase is the WHO global database of individual case safety reports (ICSRs). It is the largest database of its kind in the world, with over 20 million reports of suspected adverse effects of medicines, submitted, since 1968, by member countries of the WHO Programme for International Drug Monitoring. It is continuously updated with incoming reports. It is linked to a number of medical and drug classifications such as WHO-ART, MedDRA, WHO ICD, and WHODrug.

Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products. Adverse reaction reports are submitted by: consumers and health professionals, who submit reports voluntarily; and manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act. Data is stored from 1965 onwards.

NICHD Data and Specimen Hub
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) is a centralized resource that allows researchers to share and access de-identified data from studies funded by NICHD. DASH also serves as a portal for requesting biospecimens from selected DASH studies.

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Implementing Policies

This record is not implemented by any policy.

Credit

Record Maintainer

This record is maintained by MedDRAMSSO

Maintains

Medical Dictionary for Regulatory Activities (MedDRA) Administrators (Consortium)
Pharmaceutical and Medical Device Regulatory Science Society of Japan Tokyo (Government body)

Medical Dictionary for Regulatory Activities Terminology

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