18
ICH ICSR Implementation Guide 12 April 2013
-19-
Without harmonization, the existence of a multiplicity of message and/or content standards
across regions and regulatory jurisdictions would result in diseconomies of scale and increase
the burden for reporters. A lack of harmonisation might lead to difficulties in reconciling ICSRs
on the global level. A harmonised standard should stimulate vendors to develop ‘off-the-shelf’
tools that are interoperable due to the standard itself. A harmonised standard will also help
maximise forward compatibility of data and minimise the complexities of backward
compatibility. For these reasons, health authorities and the pharmaceutical industry are moving
in unison toward a meaningful, harmonised standard for use by all constituents.
2.4.2 How ICSRs Are Presently Transmitted and the Advantages of Electronic
Submissions
To support the ICH E2B guideline, the ICH M2 EWG published the ‘Electronic Transmission
of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1), Final
Version 2.3’ in February of 2001. At that time, prior work on the standardisation of an
electronic message by HL7 and EDIFACT (Electronic Data Interchange for Administration,
Commerce and Transport) was considered, but the ICH selected SGML (Standard Generalised
Markup Language, ISO 8879:1986) as the preferred alternative because SGML was the de facto
standard for the interchange of information. SGML also supported the multi-lingual character
sets needed across ICH regions.
In spite of this fact, the SGML-based DTD (Document Type Definition) approach is no longer
the optimal solution. As a result, the current messaging standard herein now relies upon XML
schemas. The reasoning is explained below.
2.4.2.1 Markup Languages4
First published in 1988, Standard Generalised Markup Language (SGML) is an ISO standard
(ISO 8879) designed to describe the structure and content of electronic documents, with an
original purpose of enabling the exchange of electronic documents between business entities
that need information to be available for extended periods of time (archived).It serves as a basis
for eXtensibleMarkup Language (XML), which is simpler than SGML yet maintains the most
useful parts of SGML.
SGML requires that structured documents reference a Document Type Definition (DTD) to be
valid. The DTD is the tool used to create and describe the expected SGML or XML. Simply, a
DTD specifies the syntax (the elements, attributes, entities, and notations) required in a
document authored in SGML or XML. Once a DTD is created and a document is written based
on that DTD, the document is then compared to the DTD. This is referred to as validation. If the
4‘Co-existence of Traditional EDI with XML-EDI’, Skip Stein, Management Systems
Consulting, Inc., http://www.msc-inc.net/
ICH ICSR Implementation Guide 12 April 2013
-19-
Without harmonization, the existence of a multiplicity of message and/or content standards
across regions and regulatory jurisdictions would result in diseconomies of scale and increase
the burden for reporters. A lack of harmonisation might lead to difficulties in reconciling ICSRs
on the global level. A harmonised standard should stimulate vendors to develop ‘off-the-shelf’
tools that are interoperable due to the standard itself. A harmonised standard will also help
maximise forward compatibility of data and minimise the complexities of backward
compatibility. For these reasons, health authorities and the pharmaceutical industry are moving
in unison toward a meaningful, harmonised standard for use by all constituents.
2.4.2 How ICSRs Are Presently Transmitted and the Advantages of Electronic
Submissions
To support the ICH E2B guideline, the ICH M2 EWG published the ‘Electronic Transmission
of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1), Final
Version 2.3’ in February of 2001. At that time, prior work on the standardisation of an
electronic message by HL7 and EDIFACT (Electronic Data Interchange for Administration,
Commerce and Transport) was considered, but the ICH selected SGML (Standard Generalised
Markup Language, ISO 8879:1986) as the preferred alternative because SGML was the de facto
standard for the interchange of information. SGML also supported the multi-lingual character
sets needed across ICH regions.
In spite of this fact, the SGML-based DTD (Document Type Definition) approach is no longer
the optimal solution. As a result, the current messaging standard herein now relies upon XML
schemas. The reasoning is explained below.
2.4.2.1 Markup Languages4
First published in 1988, Standard Generalised Markup Language (SGML) is an ISO standard
(ISO 8879) designed to describe the structure and content of electronic documents, with an
original purpose of enabling the exchange of electronic documents between business entities
that need information to be available for extended periods of time (archived).It serves as a basis
for eXtensibleMarkup Language (XML), which is simpler than SGML yet maintains the most
useful parts of SGML.
SGML requires that structured documents reference a Document Type Definition (DTD) to be
valid. The DTD is the tool used to create and describe the expected SGML or XML. Simply, a
DTD specifies the syntax (the elements, attributes, entities, and notations) required in a
document authored in SGML or XML. Once a DTD is created and a document is written based
on that DTD, the document is then compared to the DTD. This is referred to as validation. If the
4‘Co-existence of Traditional EDI with XML-EDI’, Skip Stein, Management Systems
Consulting, Inc., http://www.msc-inc.net/