Data element name

Sub data element name

Value

Code System Owner

NameInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Websitehttps://www.ich.org/page/contact
Email address
Phone number
Address
Code System Maintainer (Steward)Name

MedDRA Maintenance and Support Services Organization (MedDRA MSSO)

Mr. Patrick Revelle
MSSO Director

Websitehttps://www.meddra.org/contact
Email addressmssohelp@meddra.org
Phone number+1-571-508-1491 
Address12975 Worldgate Drive Herndon, VA 20170-6008
USA
Code System PublisherName

MedDRA Maintenance and Support Services Organization (MedDRA MSSO)

Mr. Patrick Revelle
MSSO Director

Websitehttps://www.meddra.org/contact
Email addressmssohelp@meddra.org
Phone number+1-571-508-1491 
Address12975 Worldgate Drive Herndon, VA 20170-6008
USA
Code System NamesFormal name of the code systemMedical Dictionary for Regulatory Activities
Short name of the code systemMedDRA
Code System Technical IdentifiersHTA-endorsed URIhttps://www.meddra.org
HTA-endorsed OID2.16.840.1.113883.6.163
Other URIs
Other OIDs
Case Sensitive Codes (TRUE/FALSE)TRUE (default value)
Code System InformationLinkhttps://www.meddra.org
Notes

MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.  MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).

MedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level.

Arrangement or agreements with HL7 for use of content
None
Version management

Code System Copyright, Intellectual Property and LicensingCopyright Statement
Copyright Informationhttps://www.meddra.org/legal-mentions
Intellectual Property Information
Licensing InformationFor information about special licensing, see https://www.meddra.org/subscription/special-licences
HTA endorsement status (Draft, In review, Endorsed for use, Pending re-endorsement, Retired) ValueIn Review
Assignment date20221027
HTA review statusLast review date
Next review date
Information current as at (date)
20230608
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2 Comments

  1. Carmela A. Couderc

    HTA-41 - Getting issue details... STATUS

  2. Jessica Bota

    This is being updated via  UP-202 - Getting issue details... STATUS