Medical Dictionary for Regulatory Activities
Items in Glossary
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A
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 Committee on challenging MedDRA issues on behalf of the user community
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
D
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 Committee
- 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 Committee
- 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
F
- FAERS
-
US FDA Adverse Event Reporting System; formerly known as "AERS"
- FDA, US
-
US Food and Drug Administration, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee
G
H
- HARTS
-
Hoechst Adverse Reaction Terminology System
- Health Canada, Canada
-
Canadian Federal department for health, is one of the ICH Observers and also a member of the ICH MedDRA Management Committee
- HLGT
-
High Level Group Term level of MedDRA
- HLT
-
High Level Term level of MedDRA
I
- ICD-9
-
International Classification of Diseases - 9th Revision
- ICD-9-CM
-
International Classification of Diseases - 9th Revision (Clinical Modification)
- ICH
-
International Council for Harmonisation of Technical Requirements for 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 Assembly
-
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 Assembly. Each of the Observers nominates non-voting participants to attend the ICH Assembly Meetings, IFPMA also participates as a non-voting member
- ICH Secretariat
-
Secretariat located in Geneva, Switzerland responsible for day-to-day management of ICH Assembly, Working Groups and MedDRA Management Committee activities as well as Global Cooperation with non ICH countries activities
- ICSR
-
Individual Case Safety Report
- IFPMA
-
International Federation of Pharmaceutical Manufacturers and Associations.
- ISO
-
ISO 9001:2008 is an internationally recognised quality management system standard developed by the International Organization for Standardization (ISO)
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 Committee
L
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 Committee
-
Is appointed by the ICH Assembly 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 Committee 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 Committee, and chairs the Committee
- MedDRA/J
-
Japanese translation of MedDRA
- MHLW, Japan
-
Japan Ministry of Health, Labour and Welfare, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee
- MHRA
-
UK Medicines and Healthcare Products Regulatory Agency, is a members of the ICH MedDRA Management Committee
- 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
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)
P
-
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 Committee
- PMDA, Japan
-
Japan Pharmaceuticals and Medical Devices Agency
- PT
-
Preferred Term
- PTC
-
MedDRA Points to Consider documents provide best practice approaches for the use of MedDRA
Q
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
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