№ files_lp_4_process_2_46359
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Provides guidance on selecting and applying MedDRA terminology for consistent reporting of adverse events and clinical information in regulatory submissions.
Year:
2014
Region / Organization:
International (ICH, EU, Japan, USA, Canada)
Subject:
Regulatory terminology for medical products
Document type:
Guidance document
Authority:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Authors:
ICH Points to Consider Working Group, MedDRA Maintenance and Support Services Organization (MSSO), Japanese Maintenance Organization
Version:
4.7
Based on MedDRA Version:
17.0
Intended audience:
MedDRA users in regulatory and industry settings
Date of release:
March 2014
Content:
Guidance on selection of MedDRA terms for reporting adverse events, diagnoses, and related clinical information
Scope:
Covers term selection principles, use of medical judgment, and special cases including congenital conditions, neoplasms, medication errors, overdose, device-related terms, and off-label use
References:
MedDRA browsing tools and related regulatory documentation
Price: 8 / 10 USD
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Year:
2024
Region / city:
Global
Topic:
MedDRA term selection, regulatory activities, medical terminology
Document type:
Guide
Organization / institution:
International Council for Harmonisation (ICH)
Author:
ICH Working Group
Target audience:
MedDRA users, regulatory bodies, industry professionals
Validity period:
Annual updates (March release)
Approval date:
March 2024
Amendment date:
Not specified
Year:
2025
Region / City:
Global
Topic:
MedDRA Term Selection
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH Working Group
Target Audience:
Regulatory professionals, MedDRA users
Period of validity:
Until the next update (Annual)
Approval Date:
March 2025
Date of changes:
N/A
Year:
2024
Region / City:
Global
Topic:
MedDRA, Data Quality, Medication Errors, Product Quality, Manufacturing Issues
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH Management Committee
Target Audience:
MedDRA users, Regulatory bodies, Industry members
Effective Period:
Ongoing
Approval Date:
September 2024
Date of Changes:
Not specified
Year:
2020
Region / City:
International
Subject:
MedDRA, Data Quality, Medication Errors, Product Quality
Document Type:
Guide
Organization / Institution:
International Council for Harmonisation (ICH)
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA users, regulatory bodies, pharmaceutical companies
Effective Period:
Ongoing
Approval Date:
October 2020
Revision Date:
N/A
Year:
2015
Region / city:
Global
Subject:
MedDRA Term Selection Changes
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA Users
Period of validity:
Not specified
Approval date:
1 March 2015
Date of changes:
March 2015
Year:
2014
Region / city:
International
Subject:
MedDRA terminology
Document Type:
Guide
Organization / Institution:
ICH (International Council for Harmonisation)
Author:
Working Group of ICH Steering Committee
Target Audience:
MedDRA users
Period of validity:
Since September 2014
Approval Date:
1 September 2014
Date of Changes:
September 2014
Contextual description:
Guide detailing changes and updates in MedDRA Term Selection for users, including updates for congenital and acquired conditions, medication errors, and examples based on MedDRA version 17.1.
Year:
2025
Region / City:
Global
Topic:
MedDRA Data Retrieval and Presentation
Document Type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA users, industry professionals, regulatory bodies
Period of Effectiveness:
March 2025
Approval Date:
March 2025
Revision Date:
N/A
Year:
2020
Region / City:
Global
Subject:
Medical Terminology, Data Retrieval
Document Type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH Working Group
Target Audience:
Regulatory Authorities, Pharmaceutical Industry Professionals
Validity Period:
Ongoing
Approval Date:
March 2020
Modification Date:
N/A
Year:
2022
Region / city:
International
Theme:
Medical terminology, Regulatory activities
Document type:
Guide
Organization:
International Council for Harmonisation (ICH)
Author:
ICH Management Committee
Target audience:
MedDRA users, healthcare professionals, regulatory authorities
Effective period:
March 2022
Date of approval:
March 2022
Date of changes:
Annually updated
Endorsements:
ICH-endorsed
License:
Public license with copyright acknowledgment
Copyright:
ICH
Modification:
Content adaptation allowed with proper acknowledgment
Summary:
A guide for selecting terms from the MedDRA terminology, aimed at users in the regulatory and medical fields.
Year:
2002
Region / City:
Manchester
Topic:
Safety, Hazard Assessment, Chemical Risk
Document Type:
Risk Assessment Guidelines
Organization / Institution:
University of Manchester
Author:
Not specified
Target Audience:
Safety Officers, Laboratory Managers, Researchers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
Pinal County, Arizona
Subject:
Public hearing, variance application
Document type:
Public notice
Organ / institution:
Pinal County Development Services Department
Author:
Pinal County Development Services Department
Target audience:
Residents of Pinal County
Period of validity:
Not specified
Approval date:
December 29, 2025
Amendment date:
Not specified
Context:
Public notice related to a variance application for a land use case in unincorporated Pinal County, Arizona, for the purpose of reducing the minimum required lot area.
Year:
2021
Region / City:
Philippines
Topic:
Recovery Plans
Document Type:
Guidance Paper
Organization / Institution:
Bangko Sentral ng Pilipinas (BSP)
Author:
World Bank
Target Audience:
BSP Bank Supervisors
Period of Application:
April 2021
Approval Date:
8 April 2021
Date of Changes:
-
Year:
2025
Region / City:
Oskaloosa, Iowa
Theme:
Public Works, City Planning
Document Type:
Agenda Memo
Institution:
City Council
Author:
Sean Murphy
Target Audience:
City Council Members, Public Works Department
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Prepared by:
Office of Non-clinical and Clinical Compliance, Pharmaceutical and Medical Devices Agency
Organization:
Pharmaceutical and Medical Devices Agency
Country:
Japan
Date of preparation:
January 26, 2017
Version:
1.0
Subject area:
Medical devices regulation
Topic:
Non-clinical studies
Document type:
Regulatory guidance
Inspection type:
Document-based conformity inspection
Legal basis:
Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Target materials:
Supporting data and documents for approval applications
Scope:
Non-clinical studies of medical devices
Intended users:
Applicants for medical device approval and inspection personnel
Year:
2024
Region / city:
Monaco
Topic:
Environmental protection, radioactive substances, marine environment
Document type:
Terms of Reference
Organ / institution:
OSPAR Radioactive Substances Committee (RSC)
Author:
OSPAR
Target audience:
Contracting Parties, Observers, Environmental professionals
Period of validity:
2024–2026
Approval date:
February 2024
Modification date:
Not specified
Note:
Year
Topic:
Health and Safety, Construction Design and Management
Document Type:
Guidance
Target Audience:
Land managers, Designers, Contractors
Year:
2017
Region / City:
California
Subject:
Energy, Distributed Energy Resources, Rulemaking
Document Type:
Rulemaking Order
Issuing Authority:
Public Utilities Commission of the State of California
Target Audience:
Utility companies, regulatory bodies, stakeholders in the energy sector
Period of Effect:
Ongoing
Approval Date:
July 13, 2017
Amendment Date:
None
Year:
2015
Region / city:
Global
Subject:
MedDRA Term Selection Changes
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA Users
Period of validity:
Not specified
Approval date:
1 March 2015
Date of changes:
March 2015
Year:
2026
Region / City:
California
Subject:
California Renewables Portfolio Standard Program
Document Type:
Decision
Agency / Institution:
Public Utilities Commission of the State of California
Author:
Alice Reynolds, Darcie L. Houck, John Reynolds, Karen Douglas, Matthew Baker
Target Audience:
Public, Stakeholders in Renewable Energy
Effective Date:
January 15, 2026
Expiration Date:
January 25, 2028
Date of Issuance:
January 16, 2026
Decision Number:
26-01-014
Deadline Extension:
January 25, 2028
Year:
2014
Region / City:
International
Topic:
Medical Device Submissions
Document Type:
Guidance Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF RPS ToC Working Group
Target Audience:
Medical device industry, regulatory authorities
Implementation Period:
Pre-RPS electronic submission environment
Approval Date:
30 June 2014
Amendment Date:
Not specified