№ lp_1_16119
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The document provides guidelines endorsed by ICH for selecting MedDRA terms in the context of regulatory reporting for medical products.
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
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MedDRA® POINTS TO CONSIDERCOMPANION DOCUMENTICH-Endorsed Guide for MedDRA UsersRelease 3.0September 2024
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
MedDRA® TERM SELECTION: POINTS TO CONSIDERICH-Endorsed Guide for MedDRA Users
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
MedDRA® DATA RETRIEVAL AND PRESENTATION: POINTS TO CONSIDERICH-Endorsed Guide for MedDRA Users on Data OutputRelease 3.25
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
Topics: 42425March UsersRelease CONSIDERICH-Endorsed