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Reference:ICH ICH E2A Guideline 1994 II A. 3.: Difference between revisions

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== Document Information ==
{{:Document:ICH ICH E2A Guideline 1994}}
{{:Document:ICH ICH E2A Guideline 1994}}


== Reference Details ==
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|-
|-
! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| G
| G
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| II A. 3.
| II A. 3.
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
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|  
|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
|  
|  
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|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
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|  
|-
|-
! scope="row" | Comment
! Comment
| Definition of unexpected adverse drug reaction
| Definition of unexpected adverse drug reaction
|}
|}


== Text ==
== Content ==
Unexpected Adverse Drug Reaction
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See section III.C.)
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See section III.C.)

Revision as of 14:27, 29 June 2026



Document information
Reference ICH ICH E2A Guideline 1994
Validity area ICH
Scope(s) G
Document name ICH E2A Guideline
Version / Revision 1994
Status Current
Document type International guideline
Language(s) EN
Description CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

E2A

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Scope G
Document part II A. 3.
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Definition of unexpected adverse drug reaction

Content

Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). (See section III.C.)

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