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Andrew Marr, PhD ICH M2 Rapporteur & EFPIA Topic Leader

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, PhD ICH M2 Rapporteur & EFPIA Topic Leader. Disclaimer :.

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Andrew Marr, PhD ICH M2 Rapporteur & EFPIA Topic Leader

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  1. 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, PhD ICH M2 Rapporteur & EFPIA Topic Leader

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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 2005 • ICH M5 guideline released for consultation at step 2 of the ICH process • Including a List of Routes of Administration and Units and Measurements 6

  7. 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

  8. 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 • Therefore: ICH needs standards issued by ISO/CEN & HL7 • But: ICH must be able to define how standards are used for ICH purposes

  9. ISO TC215 CEN TC251 Liaising Organisation HL7 Joint Initiative – Initial Membership ICH ISO TC 215 = Health Informatics

  10. 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 )

  11. 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 )

  12. ISO TC215 CEN TC251 Liaising Organisation HL7 Joint Initiative – Current Membership ICH IHTSDO CDISC GS1

  13. ISO balloting stages • Standards are following ISO process • Other SDO have their own ballots but feed into common process • Stages • Committee Draft • DraftInternational Standard (DIS) • Ballot addresses technical and editorial issues • Final DraftInternational Standard (FDIS) • Ballot addresses editorial issues only • Publication of International Standard (IS)

  14. 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 14

  15. ICH Use of ISO Standard • ICH Implementation Guide • Based upon E2B(R3) requirements • Detailed 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

  16. Current status • 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 planned from about mid-June 2010 • Shorter 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.htm • FDIS expected late 2010/early 2011

  17. ICH Step 3 Consultation • To be conducted early 2011 • Exact timing to be discussed in Tallinn • Step 3 document: detailed Implementation Guide • Specifies how ICH will use the International Standard

  18. ISO IDMP Standards (1) 18 Five Draft International Standards to be issued • prEN ISO 11615Health informatics — Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal products • prEN ISO 11616Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

  19. ISO IDMP Standards (2) prEN ISO 11238Health 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 onsubstances prEN ISO 11239Health 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 11240Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement 19

  20. Main IDMP Concepts Package Description Package Description Package Description Regulated Medicinal Product – by jurisdiction Package Description Regulated Medicinal Product Regulated Medicinal Product Regulated Medicinal Product Package Description Regulated Medicinal Product Pharmaceutical Product – common across jurisdictions Pharmaceutical Product Pharmaceutical Product Pharmaceutical Product Pharmaceutical Product Substance Substance Substance Substance Substance Strength Strength Strength Strength Strength Standard Terminology Dose Form Dose Form Dose Form Pharmaceutical Dose Form Dose Form 20

  21. Current status • Initial CD Ballot – June 2009 • Large number of comments • DIS Ballot should commence August 2010 • 5 months duration • ICH is developing an Implementation Guide • ICH will conduct testing internally • It will not make the Implementation Guide public at this stage • It will release a revised version later in the year • Step process and timings to be confirmed in Tallinn • FDIS expected mid-2011

  22. Combination of ICSR and IDMP • When 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 increased • Wider pool of reports to analyse

  23. Summary • ICH Message Standards now developed with wider input • Partnership with SDO • ICSR currently being updated & improved • IDMP being created • Improved support for safety monitoring & evaluation • Data clarity • Interoperability • Enhancement for international exchange

  24. Thank you for your attention! Questions Contact : andrew.p.marr@gsk.com

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