Items in Glossary

A

ASCII

American Standard Code for Information Interchange

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B

Biopharmaceuticals

A pharmaceutical derived from biological sources and especially one produced by biotechnology

BRP

Blue Ribbon Panels (BRPs) provide a forum for MedDRA experts from industry and regulatory authorities to discuss and make recommendations to the MedDRA Management Board on challenging MedDRA issues on behalf of the user community

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C

CAERS

US Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System

CDC

US Centers for Disease Control and Prevention

Change Request

A MedDRA Change Request (CR) allows a MedDRA subscriber to recommend changes, corrections or improvements to MedDRA and to Standardised MedDRA Queries (SMQs)

CIOMS

Council for International Organizations of Medical Sciences

Complex Change Request

Changes to MedDRA levels above PT (i.e., HLT, HLGT and SOC)

COSTART

Coding Symbols for a Thesaurus of Adverse Reaction Terms

CRO

Contract Research Organisation

CTCAE

US Common Terminology Criteria for Adverse Events

CTD

Common Technical Document

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D

DIA

Drug Information Association

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E

EEA

European Economic Area

EFPIA

European Federation of Pharmaceutical Industries and Associations, is one of the ICH Parties and also a member of the ICH MedDRA Management Board

EMA

European Medicines Agency

EU

European Union (EU is represented by the European Commission and EMA and its Expert Committees), is one of the ICH Parties and also a member of the ICH MedDRA Management Board

EudraVigilance/EVWEB

Web-based system developed by EMA to collect and store ICSRs for all drugs with adverse events occurring in Europe

EVWEB

EudraVigilance Web

Expert Panel

The MedDRA Expert Panel was established by the MSSO to provide feedback to the MSSO on difficult change requests and other problematic maintenance issues

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F

FAERS

US FDA Adverse Event Reporting System; formerly known as "AERS"

FDA

US Food and Drug Administration, is one of the ICH Parties and also a member of the ICH MedDRA Management Board

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G

GVP

Good Pharmacovigilance Practices

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H

HARTS

Hoechst Adverse Reaction Terminology System

Health Canada

Canadian Federal department for health, is one of the ICH Observers and also member of the ICH MedDRA Management Board

HLGT

High Level Group Term level of MedDRA

HLT

High Level Term level of MedDRA

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I

ICD-9

International Classification of Diseases - 9th Revision

ICD-9-CM

International Classification of Diseases - 9th Revision (Clinical Modification)

ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs

ICH Secretariat

Secretariat located in Geneva, Switzerland responsible for day-to-day management of ICH Steering Committee, Working Groups and MedDRA Management Board activities as well as Global Cooperation with non ICH countries activities

ICH Steering Committee

Is the body that governs the ICH, determines the policies and procedures for ICH, selects topics for harmonisation and monitors the progress of harmonisation initiatives. Each of the six Parties has two seats on the ICH Steering Committee. Each of the Observers nominates non-voting participants to attend the ICH Steering Committee Meetings, IFPMA also participates as a non-voting member

ICSR

Individual Case Safety Report

IFPMA

International Federation of Pharmaceutical Manufacturers and Associations, owner of MedDRA Trademark as a trustee for the ICH and also a non-voting member of ICH

ISO

ISO 9001:2008 is an internationally recognised quality management system standard developed by the International Organization for Standardization (ISO)

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J

J-ART

Japanese Adverse Reaction Terminology

JMB

Japanese Management Board

JMO

Japanese Maintenance Organization, is a partner of the MSSO and is responsible for maintaining and distributing MedDRA in Japan

JPMA

Japan Pharmaceutical Manufacturers Association, is one of the ICH Parties and also a member of the ICH MedDRA Management Board

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L

LLT

Lowest Level Term level of MedDRA

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M

MedDRA

Medical Dictionary for Regulatory Activities; developed under the auspices of ICH and maintained by MSSO, and providing an international medical dictionary applicable to all phases of biopharmaceutical and medical product development

MedDRA Code

In contrast to the typical use of the word "code" in the regulatory milieu, within MedDRA, the code refers to the eight-digit number assigned to each term and is not to be confused with the text string of the term itself. Each term in MedDRA has a unique non-expressive 8-digit code.

MedDRA Management Board

Is appointed by the ICH Steering Committee to oversee the activities of the "Maintenance and Support Services Organisation" (MSSO) for MedDRA, and ensure that the MSSO is meeting the various needs of MedDRA users. The Management Board is composed of one representative from each of the six ICH Parties and one representative from MHRA and Health Canada. The IFPMA acts as a non-voting observer on the Management Board, and chairs the Board

MedDRA/J

Japanese translation of MedDRA

MHLW

Japan Ministry of Health, Labour and Welfare, is one of the ICH Parties and also a member of the ICH MedDRA Management Board

MHRA

UK Medicines and Healthcare Products Regulatory Agency, is a members of the ICH MedDRA Management Board

MSSO

Maintenance and Support Services Organization, the repository, maintainer, and distributor of MedDRA

Multiaxiality

Terms in MedDRA may belong to more than one SOC; this property, called multiaxiality, allows for flexibility in the output and analysis of MedDRA coded data

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N

NEC

Not elsewhere classified is a standard abbreviation used to denote groupings of miscellaneous terms that do not readily fit into other hierarchical classifications within a particular SOC. The NEC designation is used only with HLTs and HLGTs for grouping purposes

NOS

Not otherwise specified terms are only found on the LLT level and are meant to represent concepts for which no further specific information is available (e.g., during coding of adverse events)

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P

PDF

Portable Document Format

Pharmacogenetic

The study of the interrelation of hereditary constitution and response to drugs

Pharmacovigilance

The pharmacological science relating to detection, assessment, understanding and prevention of adverse effects, particularly the long and short term side effects of medicines

PhRMA

Pharmaceutical Research and Manufacturers of America, is one of the ICH Parties and also a member of the ICH MedDRA Management Board

PMDA

Japan Pharmaceuticals and Medical Devices Agency

PT

Preferred Term

PTC

MedDRA Points to Consider documents provide best practice approaches for the use of MedDRA

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Q

QMS

Quality Management System

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R

Rapporteur

A representative of one of the six ICH parties designated by the Steering Committee when a new topic is formally adopted. The Rapporteur is responsible for leading a working group (EWG/IWG) and ensuring that the group keeps an up-to-date action plan and timetable, with clear deliverables and deadlines

RSS

Really Simple Syndication

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S

Simple Change

Changes to the PT and LLT levels of MedDRA

SMQ

Standardised MedDRA Query is a grouping of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest

SOC

System Organ Class level of MedDRA

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V

VAERS

US Vaccine Adverse Event Reporting System

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W

WHO

World Health Organization and one of the ICH Observers

WHO-ART

World Health Organization Adverse Reaction Terminology

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