INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
USER GUIDE
Use of EDQM terminologies for Dose Forms and Routes of Administration for Individual
Case Safety Reports in E2B(R3) message
Version 1.0, 16 November 2017
Page 1 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
Document History
Date of Title of Document Version Published for WG
Finalisation
November USER GUIDE 1.0 Step 5 E2B(R3)
2017 Use of EDQM Release EWG/IWG
terminologies for E2B(R3)
Dose Forms and
Routes of
Administration for
Individual Case
Safety Reports in
E2B(R3) message
Page 2 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
1. Introduction
This User Guide should be used in conjunction with the ICH E2B(R3) Implementation
Guide (IG) and associated documents for electronic exchange of Individual Case Safety
Reports (ICSRs)1. Specifically, this document applies only to the terms maintained by the
European Directorate for the Quality of Medicines & HealthCare (EDQM) that relate to
Pharmaceutical Dose Forms (DF) and Routes of Administration (RoA) in E2B(R3) format
messages.
1.1. Purpose of this User Guide
The purpose of this document is to provide supplementary information on DF and RoA
specified in ISO standard 11239:20122, as used in electronic exchange of ICSRs
according to the ICH E2B(R3) IG. In addition to DF and RoA standards, ISO 11239
provides standards for regulated information on units of presentation and packaging. The
units of presentation and packaging are out of scope of this User Guide.
1.2. Scope
The scope of this User Guide is for EDQM DF and RoA terms, excluding the domain of
“veterinary” terms. The specific E2B(R3) data elements are G.k.4.r.9 (Pharmaceutical
Dose Form) for DF and G.k.4.r.10 (Route of Administration) and G.k.4.r.11 (Parent
Route of Administration (in case of a parent child / foetus report)) for RoA.
1.3. Background
The IG for the E2B(R3) message specification was developed by the ICH E2B EWG for
implementation of the ISO/HL7 27953-2 ICSR message exchange standard. Among other
data elements, the ICSR contains information about DF and RoA. While DF may be
included as free text and RoA may be indicated by a code list from the ICH E2B(R2)
1 ISO/HL7 27953-2: 2011 Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -
- Part 2: Human pharmaceutical reporting requirements for ICSR. The ICH E2B(R3) package includes the
following documents, available via www.ich.org: Implementation Guide for Electronic Transmission of
Individual Case Safety Reports (ICSRs); E2B(R3) Data Elements and Message Specification; Appendix I (B)
to the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs):
Backwards and Forwards Compatibility Recommendations; Conversions for E2B(R2)-E2B(R3) compatibility;
Appendix I (C) ICH ICSR schema files; Appendix I (D) Reference Instances; Appendix I (E) Example
Instances; Appendix I (F) ICH OID list and ICH code lists; Appendix I (G) to the Implementation Guide for
Electronic Transmission of Individual Case Safety Reports (ICSRs): Technical Information; E2B(R3) Data
Element Structure in ICSR messages; Appendix I (H) BFC conversion. Clarifying information for
implementation is included in a an E2B(R3) Question and Answer (Q&A) document, which is updated on a
periodic basis.
2 ISO 11239:2012 Health informatics -- Identification of medicinal products -- Data elements and structures
for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of
presentation, routes of administration and packaging
Page 3 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
guideline, ICH E2B(R3) adopted a suite of five ISO/HL7 standards for Identification of
Medicinal Products (IDMP) in the IG.
The IDMP standards describe requirements for standardised data elements, formats, and
terminologies for the unique and unambiguous identification of medicinal products and
their constituent components. These standards enable international interoperability and
global exchange of information on medicines, at required levels of granularity, across the
regulatory and health care communities. In addition, ISO has produced a technical
specification for implementation of the standards for pharmaceutical dose forms, units of
presentation, routes of administration and packaging3.
Standardized terms for DF and RoA are included in the ISO IDMP standards and ICH
selected EDQM as the maintenance organization for the DF and RoA terms for human
medicinal products used in ICSRs. The DF and RoA terms in the EDQM Standard Terms
database comply with ISO 11239 and ISO TS 20440.
EDQM DF and RoA terms are included in the EDQM Standard Terms database (see
https://standardterms.edqm.eu/).
Note that the EDQM Standard Terms database contains terms and definitions to describe
pharmaceutical dose forms, routes and methods of administration, containers, closures,
administration devices, and units of presentation. It also contains agreed combinations of
terms, for example, to describe where two or more items are packaged together, or where
a pharmaceutical dose form and a container are described using a single term. In addition,
it contains patient-friendly terms, which are generally shorter terms that, where justified
and authorized by the competent authority, may be used on certain product labels where
space is limited.
In 2016 an updated version was released, introducing additional features such as units of
presentation, mapped terms and APIs (application programme interfaces, or web services).
In 2017 a further update was released in the form of the current database, which
introduced the tagging system that allows the inclusion of ‘non-traditional’ Standard Terms
that are intended only for specific uses such as adverse-event reporting.
For additional information, including details on change requests, consult the EDQM
website.
Should the maintenance organization for either DF or RoA change in the future, further
instruction will be provided.
1.4. Regional use
The ICH information provided here may be supplemented by regional requirements, as
further specified in regional documents. See websites of regional regulators for additional
regional considerations, as appropriate.
2. Versions/releases
3 ISO/TS 20440:2016 Health informatics -- Identification of medicinal products -- Implementation guide for
ISO 11239 data elements and structures for the unique identification and exchange of regulated information
on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
Page 4 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
Content of the EDQM Standard Terms database is updated on a continuous basis, with
new or revised terms available to users as soon as they are available (see
https://standardterms.edqm.eu/). To access Standard Terms, an account with the EDQM
Publications registration website is required (www.edqm.eu/register/).
The long term strategy of ICH is to use DF and RoA terms directly from EDQM as
published. In the near term, E2B messages should continue to use the ICH code list 14
for RoA. In the transition from the ICH code list 14 to EDQM terms, ICH will publish a
snapshot of EDQM DF and RoA terms. It is recommended that E2B adopters begin
transitioning to the ICH snapshot within twelve months from its first publication. It is
anticipated the snapshot will be refreshed twice a year and published on the ICH website
in accordance with EDQM’s Conditions of use. The ICH website should be referenced for
the current version. Note that any new E2B(R3) submission should not use deprecated
terms. Terms that have a status of “pending” should be treated as “current” terms and
are accepted.
Figure 1: Recommended Timeline for EDQM Adoption
3. Pharmaceutical Dose Forms
3.1. Data elements for EDQM TermID and version
The E2B(R3) fields are G.k.4.r.9.2a (Pharmaceutical Dose Form TermID Version
Date/Number) and G.k.4.r.9.2b (G.k.4.r.9.2b Pharmaceutical Dose Form TermID).
3.2. Term selection
Select the term that most closely captures the concept provided by the primary reporter.
If an appropriate term is unavailable, then populate G.k.4.r.9.1 (Pharmaceutical Dose
Form (free text)) as free text.
3.3. Migrating E2B(R2) Pharmaceutical Dose Form text to EDQM terms
While free text in E2B(R2) field B.4.k.7 (Pharmaceutical form [Dosage form]) may be
mapped to E2B(R3) field G.k.4.r.9.1 (Pharmaceutical Dose Form (free text)), it is
Page 5 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
recommended that a termID be selected from the EDQM Standard Terms list for
E2B(R3) field G.k.4.r.9.2b, even if free text is provided in E2B(R2).
3.4. Details of ICH E2B(R3) Data Elements for DF
G.k.4.r.9.2a Pharmaceutical Dose Form TermID Version Date/Number
User Guidance This data element provides the version date/number for the
Pharmaceutical Dose Form TermID.
Conformance Optional, but required if G.k.4.r.9.2b is populated.
Data Type 25 AN
OID None
Value Allowed Refer to ICH E2B(R3) web page for the latest information on the
appropriate version date/number of EDQM DF list.
Business Rule(s)
G.k.4.r.9.2b Pharmaceutical Dose Form TermID
User Guidance The pharmaceutical dose form should be provided using EDQM
Pharmaceutical Dose Form controlled vocabulary. If the
appropriate EDQM Pharmaceutical Dose Form TermID is not
available, free text in G.k.4.r.9.1 should be used.
Conformance Optional
Data Type 15 AN
OID
Value Allowed Refer to ICH E2B(R3) web page for the latest information on the
appropriate OID and list of EDQM DF.
Business Rule(s)
4. Routes of Administration
4.1. Data elements for EDQM TermID and version
The E2B(R3) fields are G.k.4.r.10.2a (Route of Administration TermID Version Date /
Number) and G.k.4.r.10.2b (Route of Administration TermID). Additional RoA data
elements are G.k.4.r.11.2a (Parent Route of Administration TermID Version Date /
Number) and G.k.4.r.11.2b (Parent Route of Administration TermID).
4.2. Term selection
Select the term that most closely captures the concept provided by the primary reporter.
4.3. Migrating E2B(R2) Routes of Administration text to the EDQM Standard terms
Page 6 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
The relevant E2B(R2) data are captured in field B.4.k.8 (Route of administration) and
B.4.k.9 (Parent route of administration (in case of a parent child/fetus report)) with User
Guidance that indicates use of a code list. The relevant E2B(R3) data elements
(G.k.4.r.10.2b (Route of Administration TermID) and G.k.4.r.11.2b (Parent Route of
Administration TermID)) will be coded with the EDQM Standard terms. For conversion of
legacy E2B(R2) data, see Mapping of E2B(R2) Routes of Administration terms to EDQM
terms.
4.4. Details of ICH E2B(R3) Data Elements for RoA
G.k.4.r.10.2a Route of Administration TermID Version Date/Number
User Guidance This data element provides the version date/number for the Route of
Administration TermID.
Conformance Optional, but required if G.k.4.r.10.2b is populated.
Data Type 25 AN
OID None
Value Allowed Refer to ICH E2B(R3) web page for the latest information on the
appropriate version date/number of EDQM RoA list.
Business
Rule(s)
G.k.4.r.10.2b Route of Administration TermID
User The route of administration should be provided using EDQM Route of
Guidance Administration controlled vocabulary. If the appropriate EDQM Route
of Administration TermID is not available, free text in G.k.4.r.10.1
should be used.
For a parent-child/foetus report, this data element indicates the route of
administration for the child/foetus (patient). This is usually an indirect
exposure, such as transmammary, but can include more usual routes of
administration for other drugs given to the child. The parent’s route of
administration should be provided in G.k.4.r.11.
Conformance Optional
Data Type 15 AN
OID
Value Allowed Refer to ICH E2B(R3) web page for the latest information on the
appropriate OID and list of EDQM RoA.
Business
Rule(s)
G.k.4.r.11.2a Parent Route of Administration TermID Version Date/Number
User Guidance This data element provides the version date/number for the Route of
Administration TermID.
Conformance Optional
Data Type 25 AN
OID None
Value Allowed Refer to ICH E2B(R3) web page for the latest information on the
appropriate version date/number of EDQM RoA list.
Page 7 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
INTERNATIONAL COUNCIL FOR HARMONISATION OF
TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
Business
Rule(s)
G.k.4.r.11.2b Parent Route of Administration TermID
User Guidance This data element captures the known route of administration of the
drug as taken by the parent for the dosage described in G.k.4.r.1 to
G.k.4.r.3. The parent’s route of administration should be provided as
TermID using EDQM Route of administration controlled vocabulary.
If the appropriate EDQM Route of Administration TermID is not
available, free text in G.k.4.r.11.1 should be used.
Conformance Optional
Data Type 15 AN
OID
Value Allowed Refer to ICH E2B(R3) web page for the latest information on the
appropriate OID and list of EDQM RoA.
Business
Rule(s)
Further resources
1. References to EDQM
EDQM, Standard Terms: Introduction and Guidance for Use –Version 2.1.0, 21 August
2017
2. References to relevant ISO IDMP documents
IDMP standard for pharmaceutical dose forms, units of presentation, routes of
administration and packaging: ISO 11239:2012 Health informatics -- Identification of
medicinal products -- Data elements and structures for the unique identification and
exchange of regulated information on pharmaceutical dose forms, units of presentation,
routes of administration and packaging
IDMP technical specification for implementation: ISO/TS 20440:2016 Health informatics -
- Identification of medicinal products -- Implementation guide for ISO 11239 data
elements and structures for the unique identification and exchange of regulated
information on pharmaceutical dose forms, units of presentation, routes of administration
and packaging
Page 8 of 8
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30
[email protected], http://www.ich.org
