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ICH ICSR Implementation Guide 12 April 2013
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and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of
America (PhRMA). The International Federation of Pharmaceutical Manufacturers
Associations (IFPMA) serves as ICH Secretariat. The World Health Organisation (WHO),
Health Canada and the European Free Trade Association (EFTA) participate in the ICH as
observers. Governance of ICH is via a Steering Committee, composed of representatives of the
six ICH Parties and the Observers.
In addition to the above, the ICH supports a Global Cooperation Group (GCG), which has
representatives from the six ICH Parties, the three Observers, and the Secretariat, as well as
representatives from other Regional Harmonisation Initiatives (RHIs) for pharmaceutical
regulation, namely the Asia-Pacific Economic Cooperation (APEC), the Association of
Southeast Asian Nations (ASEAN), the Gulf Cooperation Countries (GCC), the Pan American
Network on Drug Regulatory Harmonization (PANDRH) and the South African Development
Community (SADC).
This IG applies to the safety reporting requirements for medicinal products in the three main
ICH regions: Japan, the EU, and the US, as well as in those regions that are ICH Observers or
are working with ICH through the auspices of the GCG.
Further information about ICH, its EWGs and standards, and supporting documentation is
available from the ICH website. Other technical information specific for the testing and
implementation of the technical standards is made available by the ICH M2 EWG, and can also
be found at the ICH web site.
2.1.2 History of ICH ICSR guidelines
The first ICH E2B guideline, Data Elements for Transmission of Individual Case Safety Reports,
was endorsed on July 17, 1997.It was modified in November 2000, and then published with
minor editorial changes in February 2001 as the ICH Step 4 E2B (M) guideline. As part of an
ICH document management initiative, the Step 4 E2B (M) guideline was retitled as the E2B
(R2) guideline in May 2005 there was no change in business content. The ICH M2 EWG
prepared the Electronic Transmission of Individual Case Safety Reports Message Specification
guideline in 2001 to standardise the data elements for the electronic transmission of ICSRs by
identifying and defining the core elements for an ICSR, regardless of source or destination.
2.1.3 The Process of Revision in ICH
Considering the high volume of data and the large number of potential participants involved
with the world-wide exchange of safety information, there is an ongoing need for efficient
transmission of safety reports in a format that can be generated and processed nearly
automatically by a transactional database. This need has led to periodic revisions of the E2B
document, as described in Section 2.1.2 (above). The E2B(R3) message represents an iteration
of the electronic ICSR that has evolved in a controlled fashion over more than a decade.
ICH ICSR Implementation Guide 12 April 2013
-16-
and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of
America (PhRMA). The International Federation of Pharmaceutical Manufacturers
Associations (IFPMA) serves as ICH Secretariat. The World Health Organisation (WHO),
Health Canada and the European Free Trade Association (EFTA) participate in the ICH as
observers. Governance of ICH is via a Steering Committee, composed of representatives of the
six ICH Parties and the Observers.
In addition to the above, the ICH supports a Global Cooperation Group (GCG), which has
representatives from the six ICH Parties, the three Observers, and the Secretariat, as well as
representatives from other Regional Harmonisation Initiatives (RHIs) for pharmaceutical
regulation, namely the Asia-Pacific Economic Cooperation (APEC), the Association of
Southeast Asian Nations (ASEAN), the Gulf Cooperation Countries (GCC), the Pan American
Network on Drug Regulatory Harmonization (PANDRH) and the South African Development
Community (SADC).
This IG applies to the safety reporting requirements for medicinal products in the three main
ICH regions: Japan, the EU, and the US, as well as in those regions that are ICH Observers or
are working with ICH through the auspices of the GCG.
Further information about ICH, its EWGs and standards, and supporting documentation is
available from the ICH website. Other technical information specific for the testing and
implementation of the technical standards is made available by the ICH M2 EWG, and can also
be found at the ICH web site.
2.1.2 History of ICH ICSR guidelines
The first ICH E2B guideline, Data Elements for Transmission of Individual Case Safety Reports,
was endorsed on July 17, 1997.It was modified in November 2000, and then published with
minor editorial changes in February 2001 as the ICH Step 4 E2B (M) guideline. As part of an
ICH document management initiative, the Step 4 E2B (M) guideline was retitled as the E2B
(R2) guideline in May 2005 there was no change in business content. The ICH M2 EWG
prepared the Electronic Transmission of Individual Case Safety Reports Message Specification
guideline in 2001 to standardise the data elements for the electronic transmission of ICSRs by
identifying and defining the core elements for an ICSR, regardless of source or destination.
2.1.3 The Process of Revision in ICH
Considering the high volume of data and the large number of potential participants involved
with the world-wide exchange of safety information, there is an ongoing need for efficient
transmission of safety reports in a format that can be generated and processed nearly
automatically by a transactional database. This need has led to periodic revisions of the E2B
document, as described in Section 2.1.2 (above). The E2B(R3) message represents an iteration
of the electronic ICSR that has evolved in a controlled fashion over more than a decade.