Professional Documents
Culture Documents
ICSR IDMP and Standards Development 1 Nov 2010
ICSR IDMP and Standards Development 1 Nov 2010
ICSR IDMP and Standards Development 1 Nov 2010
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Outline of Presentation
Why is a new version of the ICSR
needed?
What is the added value of IDMP?
Approach to standards development
Status of programmes
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Why update the ICSR message?
ICH adopted E2B(R2) in February 2001
Past experience shows that E2B can be improved to take account of
Advancements in pharmacovigilance practice
Changing regulatory requirements
Improving consistency of use, accuracy & detail of information
Simplifying exchange of information across regions
Changes proposed include
Additional fields
Greater granularity in some fields
Greater use of terminologies
Different/clearer usage instructions for the same field
Consultation for enhancements (E2B(R3)) took place in 2005
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Why is IDMP needed?
Identification of the medicinal product involved in the adverse event
report is critical
Unique and unambiguous identification of :
Active substance
Units of measure
Ingredients
Dosage form
Units of presentation
Route of administration
Specificity within an ICSR report
Clear and accurate communication across jurisdictions (countries &
regions)
More specificity leads to more accuracy in analysis and improved
quality of the science
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ICH M5
November 2003
TheICH Steering Committee (SC) approved a
Concept Paper for the development of a new tripartite
guideline:
ICH M5 Data Elements and Standards for Drug Dictionaries
May 2005
ICH M5 guideline released for consultation at step 2
of the ICH process
Including a List of Routes of Administration and Units of
Measurement
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ICH approach to development
2006: ICH decides to no longer internally
develop its own technical specifications
Key drivers
Interoperability
Robustness
Resources & expertise
Options for inclusiveness & collaboration with
other stakeholders
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Constraints
FDA
Interoperable with other healthcare standards used in US
Single standard for all product types regulated by FDA
Standards should be HL7
EU
Standards must be ISO or CEN in order to include in legislation
Also applicable in Canada (ISO only)
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Joint Initiative – Initial Membership
ICH
ISO TC 215
Liaising ISO CEN = Health Informatics
HL7
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ISO TC215 Participating Countries
(Designated representative organisation in parenthesis)
Armenia ( SARM ) Japan ( JISC )
Australia ( SA ) Kenya ( KEBS )
Austria ( ASI ) Korea, Republic of ( KATS )
Belgium ( NBN ) Malaysia ( DSM )
Brazil ( ABNT )
Netherlands ( NEN )
New Zealand ( SNZ )
Canada ( SCC )
Norway ( SN )
China ( SAC )
Russian Federation ( GOST R )
Czech Republic ( UNMZ ) Serbia ( ISS )
Denmark ( DS ) Slovakia ( SUTN )
Finland ( SFS ) Spain ( AENOR )
France ( AFNOR ) Sweden ( SIS )
Germany ( DIN ) Turkey ( TSE )
Ireland ( NSAI ) United Kingdom ( BSI )
Italy ( UNI ) USA ( ANSI )
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ISO TC215 Observing Countries
(Designated representative organisation in parenthesis)
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Joint Initiative – Current Membership
ICH
Liaising ISO CEN
Organisation TC215
IHT TC251
CDISC SDO GS1
HL7
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ISO balloting stages
Standards are following ISO process
Other
SDO have their own ballots but feed into
common process
Stages
Committee Draft
Draft International Standard (DIS)
Ballot addresses technical and editorial issues
Final Draft International Standard (FDIS)
Ballot addresses editorial issues only
Publication of International Standard (IS)
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ISO ICSR Standards
Two Draft International Standards
ISO/DIS 27953-1
Health informatics -- Pharmacovigilance --
Individual case safety report -- Part 1: The
framework for adverse event reporting
ISO/DIS 27953-2
Health informatics -- Pharmacovigilance --
Individual case safety report -- Part 2: Human
pharmaceutical reporting requirements for ICSR
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ISO standard based upon HL7
Model
HL7 had ICSR standard
Wide scope – general details
FDA desired wider scope to deal with detail of veterinary
medicines, medical devices, food additives etc
ICH had new requirements for ICSR (E2B(R3))
EU had additional requirements – beyond scope of ICH
product types
Some countries eg. Korea had additional requirements
HL7 standard would be super-set
Specific uses would then constrain this super-set
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Constrained Message for ISO/ICH
use
HL7
ISO
Regional
ICH requirements
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ICH Use of ISO Standard
ICH Implementation Guide
Based upon E2B(R3) requirements
Detailed description for use of all relevant fields
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Current status (1)
Initial DIS Ballot – April 2009
Public awareness via ICH
Provided ability to comment on (and test) standard and ICH Implementation
Guide
Very few comments received
Draft did not pass ballot
Did not fully meet requirements
Re-run of DIS Ballot – June 2010
Shorter duration (2 months)
One month consultation within ICH for new version of Implementation Guide
Only minor comments received
Passed ballot unanimously
Details can be found on the ICH pages via
http://estri.ich.org/new-icsr/index.htm
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Current status (2)
Some minor technical changes required
FDIS ballot expected February 2011
International Standard expected early 3Q 2011
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ICH Step 3 Consultation
The target for Step 2 for the ICH Implementation
Guide is February 2011 followed by a Step 3
consultation of about 6 months duration.
Comments will be sought on how ICH will use
the International Standard – not on the standard
itself
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ISO IDMP Standards (1)
Five Draft International Standards
prEN ISO 11615 Health informatics — Identification of
medicinal products - Data elements and structures for
the unique identification and exchange of regulated
medicinal products
prEN ISO 11616 Health informatics — Identification of
medicinal products — Data elements and structures
for the unique identification and exchange of regulated
pharmaceutical product information
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ISO IDMP Standards (2)
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Main IDMP Concepts
Regulated Medicinal Product – by jurisdiction
Package
Package Description
Description
Pharmaceutical
Regulated Product
Medicinal Product
– common across jurisdictions
Pharmaceutical Product
Substance Substance
Strength Strength
Pharmaceutical
DoseDose
Form Form
Standard Terminology
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Current status
Initial CD Ballot – June 2009
Large number of comments
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Combination of ICSR and IDMP
When MPID information is included within the
ICSR the definition of the product involved will
be unambiguous
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Summary
ICH Message Standards now developed with
wider input
Partnershipwith SDOs
ICSR currently being updated & improved
IDMP being created
Contact : andrew.p.marr@gsk.com
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