ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
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*For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
to align with ICH E2D(R1) guideline. - 18
July 2003E2D
Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH
regulatory bodies. - 12
November 2003New
Codification
November
2005
E2DE2D
Revision of E2D
CodeHistory
E2D(R1) Endorsement by the Members of the ICH Assembly
under Step 2 and release for public consultation. - Date
New
Codification5 February 2024
E2D(R1)
POST-APPROVAL SAFETY DATA:
DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
E2D(R1)
ICH Consensus Guideline
Table of Contents
1. - The ICH E2D guideline provides guidance on definitions and standards for post-
5
approval individual case safety reporting, as well as good case management practices.
- Detailed guidance on the
9
specific structure, format, standards, and data elements for transmitting Individual Case Safety
10
Reports (ICSRs) is provided in the ICH E2B guideline.
- Guidance on periodic reporting of
11
aggregated safety data is covered in the ICH E2C guideline.
- 12
This guideline provides recommendations that are harmonised to the extent possible given
13
differences in post-market safety reporting requirements among ICH regions.
- 25
2.1.2
Adverse Drug Reaction (ADR)
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Adverse drug reactions, as defined by local and regional requirements, concern noxious and
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unintended responses to a medicinal product.
- 66
Product labelling may include information related to ADRs for the pharmaceutical class to
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which the medicinal product belongs.
- In some cases, ?other observations? can occur
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without any associated AEs/ADRs, while in other cases ?other observations? can occur with
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an associated AE/ADR.
- 84
For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other
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regions refer to AEs.
- 86
Refer to local and regional requirements for specifications and requirements on the reporting
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of AEs or ADRs to each Regulatory Authority.
- 89
2.2
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An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific
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point of time.
- Cases missing any of the above criteria do not qualify for reporting; due diligence
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should be exercised to collect the missing criteria.
- 6
104
An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,
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Other Observations), or both.
- Primary sources, often referred
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to as ?reporters?, include healthcare professionals and consumers who provide facts about a case
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to the MAH or regulatory authority.
- 127
2.7
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A digital platform is the software and technology used to enable transmission of information
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between users (see Section 4.3, Digital Platforms).
- Expedited Report
Primary Source
Healthcare Professional (HCP)
Consumer
Digital Platform
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130
2.8
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An organised data collection system (ODCS) is an activity that gathers data in a planned manner,
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thereby enabling review to be performed.
- MAHs should also follow the
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advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to
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287
regulatory authorities.
- MAHs may conduct an MRP
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using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be
396
selected.
- 564
Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately
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reflected in appropriate ICH E2B data elements.
- 638
Regulatory Authorities and MAHs should consider and manage duplicates when reviewing
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pharmacovigilance data, as duplicates negatively impact signal detection.
- 651
Duplicate detection relies on good quality data and is generally based on similarities but should
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take into account that information in ICSRs may differ between reporters.