the re-development of the individual case safety report ... · pdf filewhy is idmp needed?...
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International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use
The re-development of the Individual Case Safety Report (ICSR) standard (ICH E2B(R3)) and the development of standards for the Identification of Medicinal Products (IDMP) (ICH M5)
Andrew Marr, PhDICH M2 Rapporteur& EFPIA Topic Leader
Disclaimer :
The information within this presentation is based on the
presenter's expertise and experience, and represents the views of the
presenter for the purposes of a training workshop.
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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 2001Past experience shows that E2B can be improved to take account of
Advancements in pharmacovigilance practiceChanging regulatory requirementsImproving consistency of use, accuracy & detail of informationSimplifying exchange of information across regions
Changes proposed includeAdditional fieldsGreater granularity in some fieldsGreater use of terminologiesDifferent/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 substanceUnits of measureIngredientsDosage formUnits of presentationRoute of administration
Specificity within an ICSR reportClear 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
The ICH 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 2005ICH M5 guideline released for consultation at step 2 of the ICH process
Including a List of Routes of Administration and Units and Measurements
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ICH approach to development2006: ICH decides to no longer internally develop its own technical specifications
Key driversInteroperabilityRobustnessResources & expertiseOptions for inclusiveness & collaboration with other stakeholders
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ConstraintsFDA
Interoperable with other healthcare standards used in US Single standard for all product types regulated by FDAStandards should be HL7
EU Standards must be ISO or CEN in order to include in legislationAlso applicable in Canada
Therefore: ICH needs standards issued by ISO/CEN & HL7But: ICH must be able to define how standards are used for ICH purposes
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Joint Initiative – Initial Membership
ICH
HL7
ISOTC215
CENTC251
LiaisingOrganisation
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ISO TC 215= Health Informatics
ISO TC215 Participating Countries(Designated representative organisation in parenthesis)
Armenia ( SARM ) Australia ( SA ) Austria ( ASI ) Belgium ( NBN ) Brazil ( ABNT ) Canada ( SCC ) China ( SAC ) Czech Republic ( UNMZ ) Denmark ( DS ) Finland ( SFS ) France ( AFNOR ) Germany ( DIN ) Ireland ( NSAI ) Italy ( UNI )
Japan ( JISC ) Kenya ( KEBS ) Korea, Republic of ( KATS ) Malaysia ( DSM ) Netherlands ( NEN ) New Zealand ( SNZ ) Norway ( SN ) Russian Federation ( GOST R ) Serbia ( ISS ) Slovakia ( SUTN ) Spain ( AENOR ) Sweden ( SIS ) Turkey ( TSE ) United Kingdom ( BSI ) USA ( ANSI )
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ISO TC215 Observing Countries (Designated representative organisation in parenthesis)
Argentina ( IRAM ) Bulgaria ( BDS ) Croatia ( HZN ) Cyprus ( CYS ) Ecuador ( INEN ) Hong Kong, China ( ITCHKSAR ) Hungary ( MSZT ) India ( BIS ) Iran, Islamic Republic of ( ISIRI ) Israel ( SII )
Mongolia ( MASM ) Poland ( PKN ) Portugal ( IPQ ) Romania ( ASRO ) Singapore ( SPRING SG ) South Africa ( SABS ) Switzerland ( SNV ) Thailand ( TISI ) Ukraine ( DSSU ) Zimbabwe ( SAZ )
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Joint Initiative – Current Membership
ICH
HL7
ISOTC215
CENTC251
CDISC
LiaisingOrganisation IHT
SDO GS1
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ISO balloting stagesStandards are following ISO process
Other SDO have their own ballots but feed into common process
StagesCommittee 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 27953-2Health informatics -- Pharmacovigilance --Individual case safety report -- Part 2: Human pharmaceutical reporting requirements for ICSR
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ICH Use of ISO StandardICH Implementation Guide
Based upon E2B(R3) requirementsDetailed description for use of all relevant fields
Description of backwards and forwards compatibility
Significant differences between model for E2B(R2) and E2B(R3)
Thorough testing of standards and of implementation guide by ICH
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Current statusInitial DIS Ballot – April 2009
Public awareness via ICHProvided ability to comment on (and test) standard and ICH Implementation GuideVery few comments receivedDraft did not pass ballot
Did not fully meet requirements
Re-run of DIS Ballot planned from about mid-June 2010Shorter duration (2 months)One month consultation within ICH for new version of Implementation Guide
Details can be found on the ICH pages viahttp://estri.ich.org/new-icsr/index.htmFDIS expected late 2010/early 2011
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ICH Step 3 Consultation
To be conducted early 2011
Exact timing to be discussed in TallinnStep 3 document: detailed Implementation Guide
Specifies how ICH will use the International Standard
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ISO IDMP Standards (1)
Five Draft International Standards to be issued
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)
prEN ISO 11238 Health Informatics — Identification of medicinal products — Data elements and structures Health informatics —Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
prEN ISO 11239 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
prEN ISO 11240 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement
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Main IDMP Concepts
Package Description
Regulated Medicinal Product
Pharmaceutical Product Substance
Dose Form
Strength
Package Description
Regulated Medicinal Product
Pharmaceutical Product Substance
Dose Form
Strength
Package Description
Regulated Medicinal Product
Pharmaceutical Product Substance
Dose Form
Strength
Package Description
Regulated Medicinal Product
Pharmaceutical Product Substance
Dose Form
Strength
Regulated Medicinal Product – by jurisdiction
Package Description
Pharmaceutical Product – common across jurisdictions
Substance
Pharmaceutical Dose Form
Strength
Standard Terminology20
Current statusInitial CD Ballot – June 2009
Large number of comments
DIS Ballot should commence August 20105 months duration
ICH is developing an Implementation Guide
ICH will conduct testing internallyIt will not make the Implementation Guide public at this stageIt will release a revised version later in the year
Step process and timings to be confirmed in Tallinn
FDIS expected mid-2011
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Combination of ICSR and IDMPWhen MPID information is included within the ICSR the definition of the product involved will be unambiguous
MPIDs will be clearly connected to a PhPID
Value of pharmacovigilance reports circulated between jurisdictions will be increased
Confidence of correct product identification increasedWider pool of reports to analyse
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SummaryICH Message Standards now developed with wider input
Partnership with SDOICSR currently being updated & improvedIDMP being created
Improved support for safety monitoring & evaluation
Data clarityInteroperabilityEnhancement for international exchange
