EU Individual Case Safety Report (ICSR)1 Implementation Guide









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EU Individual Case Safety Report (ICSR)1 Implementation Guide

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214897 EU Individual Case Safety Report (ICSR)1 Implementation Guide

See websites for contact details

European Medicines Agency www.ema.europa.eu

Heads of Medicines Agencies www.hma.eu

The European Medicines Agency is

an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2021. Reproduction is authorised provided the source is acknowledged.

March 2021

EMA/51938/2013 Rev 2*

EU Individual Case Safety Report (ICSR)1 Implementation Guide First version adopted by Pharmacovigilance Risk Assessment

Committee (PRAC)

4 December 2014

Revision 1 agreed by EMA/Member States governance structure for pharmacovigilance

30 June 2017

EMA/Member States governance structure for pharmacovigilance

December 2020

Revision 2 submitted to EudraVigilance Expert Working Group for information

October 2020

Revision 2 submitted to Clinical Trials Facilitation group (CTFG) for information

Nov 2020

Revision 2 agreed by to PRAC January 2021

Revision 2 agreed by EU Pharmacovigilance Oversight Group February 2021 Revision 2 submitted to IT Directors for information March 2021 * Revision 2 contains the following updates: Deletion of references to ICH E2B(R2) as appropriate in view of the mandatory use of the ISO ICSR standard 27953-2:2011 based on the ICH E2B(R3) modalities by 30 June 2022; New guidance on the use of EDQM terms for routes of administration and dosage forms by

30 June 2022;

Update EudraVigilance registration process;

Update legal references to General Data Protection Regulation (GDPR) i.e., Regulation (EU)

2016/679 and the EU Data Protection Regulation (DPR), i.e. Regulation (EU) 2018/1725;

Updates to the Business Rules;

Updates related to the Clinical Trials Regulation (EU) No 536/2014; References to AS1 Gateway protocol have been removed.

1 EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance Part 2: Human

pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011) and the ICH E2B(R3) Implementation Guide

EU Individual Case Safety Report (ICSR) Implementation Guide

EMA/51938/2013 Page 2/112

Table of contents

I.A. Introduction ......................................................................................... 5

I.B. Structures and processes ..................................................................... 7

I.B.1. ICH E2B(R3) Implementation Guide and the International ICSR standard ISO/HL7 27953-2:2011 ................................................................ 8 I.B.2 Data Quality Principles of Individual Case Safety Reports

Transmitted Electronically .......................................................................... 8

I.B.3 General ICH Safety Message Flow....................................................... 9 I.C. Operation of the EU network .............................................................. 10 I.C.1. EU Implementation of ICH E2B(R3) ................................................. 10 I.C.2. ICH Safety Message Flow in the EU .................................................. 10

I.C.2.1 Electronic Data Interchange .....................................................................10

I.C.2.1.1 Security of Safety and Acknowledgement Messages .....................................11 I.C.2.1.2 Recording and storage of Safety and Acknowledgement Messages: Confidentiality

and Protection of Data ......................................................................................12

I.C.2.1.3 Operational Equipment and Services provided by the EMA to interested EDI

Partners .......................................................................................................13

I.C.2.1.3.1 WEB Trader.....................................................................................13

I.C.2.1.3.2 EVWEB ..........................................................................................13

I.C.2.1.3.3 EVPOST Function ..............................................................................14

I.C.2.1.4 Registration Process ............................................................................14

I.C.2.1.5 System testing requirements .................................................................14

I.C.2.1.5.1 Communication and validation testing ....................................................14

I.C.2.1.5.2 Gateway Configuration and communication testing ....................................15

I.C.2.1.5.3 XML E2B testing phase.......................................................................16

I.C.2.1.6 What to do in case of system failure.........................................................17

I.C.2.1.6.1 Failure of Safety Message generation .....................................................17

I.C.2.1.6.2 Failure of message transmission by the senders Gateway............................17 I.C.2.1.6.3 Failure of message receipt by the Gateway at the level of the EMA ................18 I.C.2.1.6.4 Failure of message processing by the EudraVigilance system .......................18

I.C.2.1.6.5 Failure of the EudraVigilance Web application...........................................19

I.C.2.1.7 XML conformance................................................................................19

I.C.2.1.8 Processing and Acknowledgement of Receipt of Safety Messages .....................19 I.C.2.2 Retransmission of ICSRs from EudraVigilance to National Competent Authorities....24 I.C.2.2.1 Retransmission rules for post-authorisation E2B(R3) ICSRs ............................24

I.C.2.2.2 Retransmission rules for Clinical Trial SUSARs ............................................26

See websites for contact details

European Medicines Agency www.ema.europa.eu

Heads of Medicines Agencies www.hma.eu

The European Medicines Agency is

an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2021. Reproduction is authorised provided the source is acknowledged.

March 2021

EMA/51938/2013 Rev 2*

EU Individual Case Safety Report (ICSR)1 Implementation Guide First version adopted by Pharmacovigilance Risk Assessment

Committee (PRAC)

4 December 2014

Revision 1 agreed by EMA/Member States governance structure for pharmacovigilance

30 June 2017

EMA/Member States governance structure for pharmacovigilance

December 2020

Revision 2 submitted to EudraVigilance Expert Working Group for information

October 2020

Revision 2 submitted to Clinical Trials Facilitation group (CTFG) for information

Nov 2020

Revision 2 agreed by to PRAC January 2021

Revision 2 agreed by EU Pharmacovigilance Oversight Group February 2021 Revision 2 submitted to IT Directors for information March 2021 * Revision 2 contains the following updates: Deletion of references to ICH E2B(R2) as appropriate in view of the mandatory use of the ISO ICSR standard 27953-2:2011 based on the ICH E2B(R3) modalities by 30 June 2022; New guidance on the use of EDQM terms for routes of administration and dosage forms by

30 June 2022;

Update EudraVigilance registration process;

Update legal references to General Data Protection Regulation (GDPR) i.e., Regulation (EU)

2016/679 and the EU Data Protection Regulation (DPR), i.e. Regulation (EU) 2018/1725;

Updates to the Business Rules;

Updates related to the Clinical Trials Regulation (EU) No 536/2014; References to AS1 Gateway protocol have been removed.

1 EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance Part 2: Human

pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011) and the ICH E2B(R3) Implementation Guide

EU Individual Case Safety Report (ICSR) Implementation Guide

EMA/51938/2013 Page 2/112

Table of contents

I.A. Introduction ......................................................................................... 5

I.B. Structures and processes ..................................................................... 7

I.B.1. ICH E2B(R3) Implementation Guide and the International ICSR standard ISO/HL7 27953-2:2011 ................................................................ 8 I.B.2 Data Quality Principles of Individual Case Safety Reports

Transmitted Electronically .......................................................................... 8

I.B.3 General ICH Safety Message Flow....................................................... 9 I.C. Operation of the EU network .............................................................. 10 I.C.1. EU Implementation of ICH E2B(R3) ................................................. 10 I.C.2. ICH Safety Message Flow in the EU .................................................. 10

I.C.2.1 Electronic Data Interchange .....................................................................10

I.C.2.1.1 Security of Safety and Acknowledgement Messages .....................................11 I.C.2.1.2 Recording and storage of Safety and Acknowledgement Messages: Confidentiality

and Protection of Data ......................................................................................12

I.C.2.1.3 Operational Equipment and Services provided by the EMA to interested EDI

Partners .......................................................................................................13

I.C.2.1.3.1 WEB Trader.....................................................................................13

I.C.2.1.3.2 EVWEB ..........................................................................................13

I.C.2.1.3.3 EVPOST Function ..............................................................................14

I.C.2.1.4 Registration Process ............................................................................14

I.C.2.1.5 System testing requirements .................................................................14

I.C.2.1.5.1 Communication and validation testing ....................................................14

I.C.2.1.5.2 Gateway Configuration and communication testing ....................................15

I.C.2.1.5.3 XML E2B testing phase.......................................................................16

I.C.2.1.6 What to do in case of system failure.........................................................17

I.C.2.1.6.1 Failure of Safety Message generation .....................................................17

I.C.2.1.6.2 Failure of message transmission by the senders Gateway............................17 I.C.2.1.6.3 Failure of message receipt by the Gateway at the level of the EMA ................18 I.C.2.1.6.4 Failure of message processing by the EudraVigilance system .......................18

I.C.2.1.6.5 Failure of the EudraVigilance Web application...........................................19

I.C.2.1.7 XML conformance................................................................................19

I.C.2.1.8 Processing and Acknowledgement of Receipt of Safety Messages .....................19 I.C.2.2 Retransmission of ICSRs from EudraVigilance to National Competent Authorities....24 I.C.2.2.1 Retransmission rules for post-authorisation E2B(R3) ICSRs ............................24

I.C.2.2.2 Retransmission rules for Clinical Trial SUSARs ............................................26


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