Step 4 in

Updated Updated Updated Updated Updated Updated Updated Updated Updated

San Diego
File name
No. Document title File format Package 1.00 Package 1.01 Package 1.02 Package 1.03 Package 1.04 Package 1.05 Package 1.06 Package 1.07 Package 1.08 Package 1.09
(except version number)
14 Nov 2012 12 Apr 2013 12 Nov 2014 10 Apr 2015 10 Nov 2016 01 June 2017 16 Nov 2017 07 June 2018 22 Jul 2020 11 Mar 2022
Version Version Note Version Note Version Note Version Note Version Note Version Note Version Note Version Note Version Note

Implementation Guide for

Incorporate Q&A
Electronic Transmission of Individual Case Safety Reports
1&2 1_ICH_ICSR_Implementation Guide pdf 5.00 5.01 - - 5.02 and provide - - - - -
(ICSRs)
addititional clarity
E2B(R3) Data Elements and Message Specification

Editorial corrections
Appendix I (B) to the Implementation Guide for
Corrections to made
Electronic Transmission of Individual Case Safety Reports Change
align with other Update scenarios
(ICSRs) 3_ICH_ICSR_BFC_Specification pdf 2.00 - 2.01 - 2.02 reference from - - - - 2.03
documents in the and examples of
Backwards and Forwards Compatibility Recommendations M5 to ISO IDMP
IG package 5.2.6

Corrections to
align with other
Conversions for E2B(R2)-E2B(R3) compatibility 3_BFC Element Mapping excel 2.00* 2.01 2.02 - - - - - - -
documents in the
IG package

4 Appendix I '(C) ICH ICSR schema files 4_ICH_ICSR_Schema_Files htm, xsd 1.00 - - - - - - - - -
Added
5 Appendix I (D) Reference Instances 5_Reference_Instances xml 3.0 - 3.1 "codeSystemVer - - - - - - -
sion"
6 Appendix I (E) Example Instances 6_Example_Instances excel, xml 1.0 - - - - - - - - -

Correct Japanese
Add "mg/mL" to labels (code 2: from
CL25 ich-dose- 乳児 to 乳幼児, code
Add
strength-unit. 3: from 児童 to 小児)
leading 0s Change
in the CL9 ich-
to “CL14 UCUM code
Add 'current flag' Version number patient-age-group.
Route-of- for decade
pdf, xml, xsd, xsl, to all code lists, was corrected Correct typo of
7 Appendix I (F) ICH OID list and ICH code lists 7_E2B Bilingual Code Lists 2.3 2.4 2.5 2.6 Administrat 2.7 2.8 (from "10a" to 2.9 - - -
txt, png correct two from 2.6 to 2.7 English label (code
ion” to "10.a") in the
labels after the sign-off 057) and change the
make every CL26 ich-
on 10/Nov/2016. current flag (code
code 3 interval-unit.
This correction 046: from y to n) in
digits.
was approved by the CL14 ich-r2-
the Assembly. route-of-
administration.

Added
Appendix I (G) to the Implementation Guide for
"codeSystemVer Change
Electronic Transmission of Individual Case Safety Reports
8_Technical Information pdf 1.00 - Typo only 1.01 sion", delete - 1.02 reference from - - - - -
(ICSRs)
unneccesary M5 to ISO IDMP
Technical Information
nullFlavor

Corrections to
align with other
E2B(R3) Data Element Structure in ICSR messages 8_Reference excel 1.00 - 1.10 - - - - - - -
documents in the
IG package

This version is This version is

This version
zip updated by EU. updated by EU.
is updated by
9 Appendix I (H) BFC conversion 9_BFC_conversion (xml, xsd files 1.0 - - - EU 2.0 Correct errors EU 2.1 EU 2.5 Added readme file, - - -
EU. Correct
included) and add regional that includes release
errors.
requirements. notes.

Deleted snapshot
mechanism
for retrieving
EDQM terms;
Addition of the
method for
extraction of the
EDQM Standard
Terms and codes
User Guide for Use of EDQM Terminologies for Dosage 10_User_Guide_Dose_Forms_and_
10 pdf - - - - - - 1.0 - 1.1 by using EDQM -
Forms and Routes of Administration Routes_of_Administration
API

Addition of
Mapping table
between ICH
terms and EDQM
Standard terms
for route of
administration

11_ICH E2B(R3) Core Data Elements and

11 ICH E2B(R3) Core Data Elements and Business Rules excel - - - - - - - 1.0 - -
Business Rules

*: This document was not included in the IG package provided to the Steering Committee in San Diego 2012