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Unified Medical Language System® (UMLS®)

2012AB MedDRA Source Information

Web site:
http://www.meddramsso.com/index.asp

Authority
The Medical Dictionary for Regulatory Activities (MedDRA) was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee. The Maintenance and Support Services Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators.

Purpose
MedDRA was designed for the specific use of sharing regulatory information and clinical safety data for human medical products worldwide.

Description
MedDRA is an international medical terminology with an emphasis on use for data entry, retrieval, analysis, and display. It applies to all phases of drug development, excluding animal toxicology, and to the health effects and malfunction of devices. An appendix includes concept descriptions which describe how a medical concept is interpreted, used, and classified within the MedDRA terminology. It is not intended as a medical definition. The concept descriptions are intended to aid the consistent and accurate use of MedDRA in coding, retrieval, and analysis.

Metathesaurus Scope
The Metathesaurus representation of MedDRA includes all data from the .asc files in the MedAscii directory of the MedDRA release. The Metathesaurus also includes certain expansions of abbreviations in terms as well as Americanizations for British spellings.

The Metathesaurus also includes the following MedDRA translations:

  1. Czech
  2. Dutch
  3. French
  4. German
  5. Hungarian
  6. Italian
  7. Japanese
  8. Portuguese
  9. Spanish

Audience
Users of MedDRA include pharmaceutical companies, biotechnology companies, device manufacturers, regulatory authorities, CROs, system developers, support service organizations, health care professionals, researchers and other interested parties outside of the regulated pharmaceutical/biological industry.

Update Frequency
MedDRA is updated in March and September.

Metathesaurus Update Frequency
MedDRA is an updated source in each Metathesaurus release. The March update is included in the November Metathesaurus release. The September updated is included in the April Metathesaurus release.

Sites Consulted

  1. MedDRA MSSO. Northrop Grumman Corporation; c2010. Welcome to MedDRA and the MSSO; [updated 2010 Nov 22; cited 2010 Nov 23]. Available from: http://www.meddramsso.com/index.asp