14
ICH ICSR Implementation Guide 12 April 2013
-15-
information relies on the consistent and uniform interpretation of definitions for common data
elements and standard transmission procedures, such as those provided in this document.
Over the last decade as the number of case reports has increased, exchange of ICSRs has
increasingly shifted from paper-based to electronic reports and electronic transmission of case
safety information has become an important component of global pharmacovigilance. The ICH
released a consensus electronic standard for ICSRs in 1997 and this standard has undergone a
number of revisions since it was first adopted. The ICH E2B(R2) standard has been used for
regulatory compliance purposes for several years and, indeed, is now mandatory in some ICH
regulatory jurisdictions and is widely accepted.
Development of the standard described in this IG represents a change of the ICH process, as the
messaging standard was developed through a partnership with external Standards Development
Organisations (SDOs).Prior to the message standard described in this IG, ICH electronic
messaging standards were developed by the ICH M2 EWG for Electronic Standards for the
Transmission of Regulatory Information(ESTRI).Specifically, the current message standard was
developed through a collaborative relationship between the ICH and the Joint Initiative Council
(JIC) the JIC is a partnership of the International Organisation for Standardisation (ISO), the
Health Level Seven (HL7), the European Committee for Standardisation (CEN), the Clinical
Data Interchange Standards Consortium (CDISC), the International Health Terminology
Standards Development Organisation (IHTSDO), and GS12. The ICSR standard named ‘ISO /
HL7 27953-2: 2011 Health informatics --Individual case safety reports (ICSRs) in
pharmacovigilance --Part 2: Human pharmaceutical reporting requirements for ICSR’ is
available at the ISO website (http://www.iso.org/iso/store.htm).
2.0 BACKGROUND
2.1 General Background and History of ICH
2.1.1 The ICH and its Partners
The ICH was organised to provide a consensus forum for tripartite harmonisation initiatives to
be developed with input from both regulatory and pharmaceutical industry representatives. The
primary focus of the ICH is to harmonise some of the technical requirements for the registration
of pharmaceutical products among Japan, the European Union (EU)and the United
States(US).The six ICH Parties in those three regions are the European Commission for the EU,
the European Federation of Pharmaceutical Industries’ Associations (EFPIA), the Ministry of
Health, Labour, and Welfare, Japan (MHLW) /the Pharmaceuticals and Medical Devices
Agency (PMDA), the Japan Pharmaceutical Manufacturers Association (JPMA), the US Food
2GS1 is an international not-for-profit association dedicated to the design and implementation of
global standards and solutions to improve the efficiency and visibility of supply and demand
chains globally and across sectors.
ICH ICSR Implementation Guide 12 April 2013
-15-
information relies on the consistent and uniform interpretation of definitions for common data
elements and standard transmission procedures, such as those provided in this document.
Over the last decade as the number of case reports has increased, exchange of ICSRs has
increasingly shifted from paper-based to electronic reports and electronic transmission of case
safety information has become an important component of global pharmacovigilance. The ICH
released a consensus electronic standard for ICSRs in 1997 and this standard has undergone a
number of revisions since it was first adopted. The ICH E2B(R2) standard has been used for
regulatory compliance purposes for several years and, indeed, is now mandatory in some ICH
regulatory jurisdictions and is widely accepted.
Development of the standard described in this IG represents a change of the ICH process, as the
messaging standard was developed through a partnership with external Standards Development
Organisations (SDOs).Prior to the message standard described in this IG, ICH electronic
messaging standards were developed by the ICH M2 EWG for Electronic Standards for the
Transmission of Regulatory Information(ESTRI).Specifically, the current message standard was
developed through a collaborative relationship between the ICH and the Joint Initiative Council
(JIC) the JIC is a partnership of the International Organisation for Standardisation (ISO), the
Health Level Seven (HL7), the European Committee for Standardisation (CEN), the Clinical
Data Interchange Standards Consortium (CDISC), the International Health Terminology
Standards Development Organisation (IHTSDO), and GS12. The ICSR standard named ‘ISO /
HL7 27953-2: 2011 Health informatics --Individual case safety reports (ICSRs) in
pharmacovigilance --Part 2: Human pharmaceutical reporting requirements for ICSR’ is
available at the ISO website (http://www.iso.org/iso/store.htm).
2.0 BACKGROUND
2.1 General Background and History of ICH
2.1.1 The ICH and its Partners
The ICH was organised to provide a consensus forum for tripartite harmonisation initiatives to
be developed with input from both regulatory and pharmaceutical industry representatives. The
primary focus of the ICH is to harmonise some of the technical requirements for the registration
of pharmaceutical products among Japan, the European Union (EU)and the United
States(US).The six ICH Parties in those three regions are the European Commission for the EU,
the European Federation of Pharmaceutical Industries’ Associations (EFPIA), the Ministry of
Health, Labour, and Welfare, Japan (MHLW) /the Pharmaceuticals and Medical Devices
Agency (PMDA), the Japan Pharmaceutical Manufacturers Association (JPMA), the US Food
2GS1 is an international not-for-profit association dedicated to the design and implementation of
global standards and solutions to improve the efficiency and visibility of supply and demand
chains globally and across sectors.