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ICH ICSR Implementation Guide 12 April 2013
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Table 1: E2B (R3) data elements and IDMP OIDs
Element id Element Name OID Reference10
D.8.r.2b Medicinal Product Identifier (MPID) ISO11615 MPID
D.8.r.3b Pharmaceutical Product Identifier (PhPID) ISO11616 PhPID
D.10.8.r.2b Medicinal Product Identifier (MPID) ISO11615 MPID
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) ISO11616 PhPID
G.k.2.1.1b Medicinal Product Identifier (MPID) ISO11615 MPID
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID) ISO11616 PhPID
G.k.2.3.r.2b Substance/Specified Substance TermID ISO11238 IDMP
Substance
G.k.4.r.9.2b Pharmaceutical Dose Form TermID ISO11239 IDMP Dosage
Forms &Routes of Admin
G.k.4.r.10.2b Route of Administration TermID ISO11239 IDMP Dosage
Forms &Routes of Admin
G.k.4.r.11.2b Parent Route of Administration TermID ISO11239 IDMP Dosage
Forms &Routes of Admin
3.2.1.2 MedDRA -the Medical Dictionary for Regulatory Activities
MedDRA® -the Medical Dictionary for Regulatory Activities -is a medical terminology used to
classify adverse event information associated with the use of biopharmaceuticals and other
medical products (e.g. medical devices and vaccines). Coding these data to a standard set of
MedDRA terms allows health authorities and the biopharmaceutical industry to more readily
exchange and analyze data related to the safe use of medical products11.
MedDRA trademark is owned by the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) on behalf of ICH, and MedDRA was developed by
the ICH. The MSSO -Maintenance and Support Services Organization -serves as the
repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date
information regarding MedDRA and its application within the biopharmaceutical industry and
regulators. MedDRA subscribers submit proposed changes to the terminology. The MSSO
includes a group of internationally based physicians who review all proposed subscriber
changes and provide a timely response directly to the requesting subscriber.
The ICH ICSR utilises MedDRA to code a number of medical concepts, such as adverse
reactions or events, indications for drug use, medical history, etc. The following elements
require MedDRA coding at the Lowest Level Term (LLT).Please note that only one version of
MedDRA can be used in a single ICSR.
10These will be replaced with the registered OID reference when it is available.
11This description of MedDRA is taken from the webpage of the MSSO at
http://www.meddramsso.com/. For more information please see webpage for ICH.
ICH ICSR Implementation Guide 12 April 2013
-25-
Table 1: E2B (R3) data elements and IDMP OIDs
Element id Element Name OID Reference10
D.8.r.2b Medicinal Product Identifier (MPID) ISO11615 MPID
D.8.r.3b Pharmaceutical Product Identifier (PhPID) ISO11616 PhPID
D.10.8.r.2b Medicinal Product Identifier (MPID) ISO11615 MPID
D.10.8.r.3b Pharmaceutical Product Identifier (PhPID) ISO11616 PhPID
G.k.2.1.1b Medicinal Product Identifier (MPID) ISO11615 MPID
G.k.2.1.2b Pharmaceutical Product Identifier (PhPID) ISO11616 PhPID
G.k.2.3.r.2b Substance/Specified Substance TermID ISO11238 IDMP
Substance
G.k.4.r.9.2b Pharmaceutical Dose Form TermID ISO11239 IDMP Dosage
Forms &Routes of Admin
G.k.4.r.10.2b Route of Administration TermID ISO11239 IDMP Dosage
Forms &Routes of Admin
G.k.4.r.11.2b Parent Route of Administration TermID ISO11239 IDMP Dosage
Forms &Routes of Admin
3.2.1.2 MedDRA -the Medical Dictionary for Regulatory Activities
MedDRA® -the Medical Dictionary for Regulatory Activities -is a medical terminology used to
classify adverse event information associated with the use of biopharmaceuticals and other
medical products (e.g. medical devices and vaccines). Coding these data to a standard set of
MedDRA terms allows health authorities and the biopharmaceutical industry to more readily
exchange and analyze data related to the safe use of medical products11.
MedDRA trademark is owned by the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) on behalf of ICH, and MedDRA was developed by
the ICH. The MSSO -Maintenance and Support Services Organization -serves as the
repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date
information regarding MedDRA and its application within the biopharmaceutical industry and
regulators. MedDRA subscribers submit proposed changes to the terminology. The MSSO
includes a group of internationally based physicians who review all proposed subscriber
changes and provide a timely response directly to the requesting subscriber.
The ICH ICSR utilises MedDRA to code a number of medical concepts, such as adverse
reactions or events, indications for drug use, medical history, etc. The following elements
require MedDRA coding at the Lowest Level Term (LLT).Please note that only one version of
MedDRA can be used in a single ICSR.
10These will be replaced with the registered OID reference when it is available.
11This description of MedDRA is taken from the webpage of the MSSO at
http://www.meddramsso.com/. For more information please see webpage for ICH.