ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

The completed comments form should be sent to

Metadata

Provider:

URL:

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-step-2b-revision-1_en.pdf

Retrieved on:

Dienstag, März 12, 2024

Information

Tags:

Consensus, Duplication, Address, Fetus, Pregnancy, Translation, Health, Health care, Employment, Region, Draft, Guideline, Diagnosis, Domenico, Data set, Efficacy, Literature, Trial of the century, Mortality, Identifiability, Software, Social media, Adolescence, Committee, Marketing, Pharmacovigilance, Convulsion, INTRODUCTION, Agency, Data collection, Causality, Documentation, Data, European, CHMP, MRP, Public, Case management, Abuse, Child, Drug overdose, HCP, Digital platform, ADR, Responsibility, Language, Use, Chronology, Disulfiram-like drug, Calendar, Digital, Drug, Vaccine, Threshold limit value, Observation, Section 5, MAH, Safety, Gestational age, ICH, SAFETY, Abstract, Section 4, Clinical trial, Consumer, GOOD, Madiga, Abbreviation, Reproduction, Birth, Collection, EMA, Mutagen, Medical dictionary, Aes, Medicine, Registry, PSP, Content, MedDRA, Report, Seriousness, Nature, ICMJE recommendations, Risk, Communication, Step, Narrative, Autopsy, Approximation error, Death, Patient, Privacy, Role, Journalist, Publication, ICSR, Riau rupiah, Medical device

Geotags:

EUROPEAN UNION, AE

Zusammenfassung

Key Points:

The completed comments form should be sent to
[email protected]
*For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
to align with ICH E2D(R1) guideline.
18
July 2003
E2D

Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH
regulatory bodies.
12
November 2003
New
Codification
November
2005
E2D

E2D

Revision of E2D
Code

History

E2D(R1) Endorsement by the Members of the ICH Assembly
under Step 2 and release for public consultation.
Date
New
Codification

5 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)

26

Adverse drug reactions, as defined by local and regional requirements, concern noxious and

27

unintended responses to a medicinal product.
66
Product labelling may include information related to ADRs for the pharmaceutical class to

67

which the medicinal product belongs.
In some cases, ?other observations? can occur
78

without any associated AEs/ADRs, while in other cases ?other observations? can occur with

79

an associated AE/ADR.
84
For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

85

regions refer to AEs.
86
Refer to local and regional requirements for specifications and requirements on the reporting

87

of AEs or ADRs to each Regulatory Authority.
89
2.2

90

An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

91

point of time.
Cases missing any of the above criteria do not qualify for reporting; due diligence
99

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,

105

Other Observations), or both.
Primary sources, often referred
112

to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

113

to the MAH or regulatory authority.
127
2.7

128

A digital platform is the software and technology used to enable transmission of information

129

between users (see Section 4.3, Digital Platforms).
Expedited Report
Primary Source

Healthcare Professional (HCP)

Consumer

Digital Platform

7

130

2.8

131

An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

132

thereby enabling review to be performed.
MAHs should also follow the
286

advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

13

287

regulatory authorities.
MAHs may conduct an MRP
395

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

565

reflected in appropriate ICH E2B data elements.
638
Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

639

pharmacovigilance data, as duplicates negatively impact signal detection.
651
Duplicate detection relies on good quality data and is generally based on similarities but should

652

take into account that information in ICSRs may differ between reporters.