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ICH Update: Developments and Future Directions

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ICH Update: Developments and Future Directions IV Pan American Conference on Drug Regulatory Harmonization Boca Chica, Dominican Republic 2-4 March, 2005 – PowerPoint PPT presentation

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Title: ICH Update: Developments and Future Directions


1
ICH Update Developments and Future Directions
  • IV Pan American Conference on Drug Regulatory
    Harmonization
  • Boca Chica, Dominican Republic
  • 2-4 March, 2005
  • Mike Ward
  • Health Canada

2
A Unique Approach
  • International Conference on Harmonisation (ICH)
    was created in 1990
  • Agreement between the EU, Japan and the USA to
    harmonize different regional requirements for
    registration of pharmaceutical drug products
  • Unique because joint effort by regulators and
    associated pharmaceutical industry trade
    associations

3
ICH Objectives
  • Identification and elimination of the need to
    duplicate studies to meet different regulatory
    requirements
  • More efficient use of resources in the RD
    process, as a consequence
  • Quicker access for patients to safe and effective
    new medicines

4
Working Groups
SAFETY EFFICACY QUALITY
MULTIDISCIPLINARY
STEERING COMMITTEE Endorses topics, guidelines
and monitors progress
5
Retrospective
  • ICH a mature harmonization initiative
  • Over 50 technical guidelines, a dictionary of
    medical terms, electronic standards and a common
    format for drug registration
  • Six ICH conferences to date, including ICH 6 in
    Osaka, Japan, November 2003
  • Witnessing increased interest in and use of ICH
    guidelines globally
  • Formation and evolution of Global Cooperation
    Group (GCG)

6
Time to Reflect
  • Following over a decade of significant
    achievements in the harmonization of quality,
    safety and efficacy requirements for the
    registration of new drugs in the three ICH
    regions, is the work of ICH mostly done? Will ICH
    become a maintenance-only organization?

7
No, however
  • Appropriate time to evaluate the future of ICH to
    ensure
  • Proper balance between maintenance and new
    activities
  • New topics are of high value and objectives are
    achievable
  • Most efficient use and management of resources
  • Flexible enough to deal with evolving science and
    technologies
  • More transparent

8
ICH Output since 3rd Pan-Am Conference, April 02
(1)
  • New products
  • Five technical guidelines
  • 3 Quality Stability (Q1E, Q1F), Biotech
    comparability (Q5E)
  • 2 Efficacy post-approval safety (E2D) and
    pharmacovigilance planning (E2E)
  • Specifications established for electronic
    submissions eCTD
  • Four Considerations documents 3 on gene
    therapy, 1 on gender and clinical trials

9
ICH Output since 3rd Pan-Am Conference (2)
  • Responding to user needs and new data
    maintenance, improvement, clarification
    activities
  • Introduction of question and answers documents
    (M4-CTD/eCTD, E5-ethnic factors,
    E2B(M)-transmission of safety case reports)
  • Revision of Quality guidelines on stability (Q1A)
    and impurities (Q3B)
  • Maintenance of limits for residual solvents (Q3C)
  • New addendum to periodic safety update reports
    (E2C) granularity annex to Common Technical
    Document (CTD) guidance

10
ICH Output since 3rd Pan-Am Conference (3)
  • MedDRA
  • Continual improvement MedDRA version 8.0
    scheduled for release March 2005
  • Now available in 8 languages, including Spanish
    and Portuguese
  • New draft Points to Consider documents on term
    selection and data retrieval/presentation
  • Release of first Standardized MedDRA Queries
    (SMQs) collaboration with Council for
    International Organization of Medical Services
    (CIOMS)

11
ICH Developments and Future Directions
  • Themes
  • New topics facilitating innovation
  • New topics promoting safety/public health
  • Regulatory communication
  • Maintenance/implementation
  • Mechanics of ICH
  • Transparency and communication

12
New Topics Facilitating Innovation
  • Examples
  • Q5E comparability of biotech/biological products
    subject to manufacturing changes
  • Q8 pharmaceutical development
  • Q9 risk management application to quality
    requirements and practices
  • Serve to facilitate innovation and improvement
  • More informed, risked-based approach to
    regulation
  • Consistent with FDAs GMPs for the 21st Century
    initiative

13
New TopicsPromoting Safety/Public Health
  • Examples
  • E2E pharmacovigilance planning (completed)
  • E14/S7B QT prolongation (draft)
  • Topics identified by regulators
  • Considered important in contributing to drug
    safety and public health
  • Potential new pharmacovigilance topics to be
    considered by ICH following gap analysis of
    current regional guidelines

14
New Topics Other projects
  • Q4B regulatory acceptance of (Japanese, European
    and US) pharmacopeial interchangeability
  • Process established
  • Piloting
  • S8 immunotoxicology
  • Nonclinical test methods and decision tree for
    assessing immunosuppression caused by
    non-biologic pharmaceuticals

15
Regulatory Communication (1)
  • ICH has sought to enhance regulatory
    communication through the development of
  • Standardized data elements, example E2B
  • Controlled vocabularies, example MedDRA
  • Common format for drug registration CTD
  • Electronic specifications and standards for the
    transmission of such information, example ESTRI
    and eCTD

16
Regulatory Communication (2)
  • Benefits
  • Speak same language promotes communication
  • Quality, accuracy and consistency of information
  • Improve timeliness of communications (electronic
    transmission)
  • CTD/eCTD reduces delays and costs associated with
    registration of drug applications

17
Regulatory Communication (3)
  • Status of CTD/eCTD implementation
  • As of July 2003 CTD mandatory in EU and Japan,
    highly recommended in US and Canada
  • Integration of CTD in existing regulatory
    frameworks
  • No significant difficulties encountered
  • New era eCTDs now being submitted in all ICH
    regions

18
Regulatory Communication (4)
  • New M5 Data elements and standards for drug
    dictionaries
  • For use in describing medicinal products and
    active ingredients
  • Controlled vocabulary includes units, routes of
    administration, pharmaceutical forms
  • Electronic message specifications to be developed

19
Maintenance/Implementation (1)
  • Critical aspects of the ICH harmonization process
    considering need to ensure
  • continued relevance and improvement of an
    ever-growing number of guidelines
  • consistent and intended use by regulators and
    industry
  • Tools/mechanisms
  • Qs and As, addenda, revisions, points to consider
  • Change control and maintenance processes eCTD,
    E2B(M) and Q3C
  • New maintenance of ICH controlled terminology
    lists

20
Maintenance/Implementation (2)
  • Tools/mechanisms
  • MedDRA maintenance and support service
    organization (MSSO)
  • Creation of implementation working groups (e.g.,
    for CTD/eCTD, E2B(M)) and implementation tool
    (new)
  • Implementation standing item on ICH Steering
    Committee agenda
  • General procedures and roles/responsibilities
    under development

21
Mechanics of ICH
  • Given costs involved in harmonization activities,
    it is important that effective structure and
    procedures are in place to ensure maximum benefit
    is derived
  • Periodic reassessment of mandate, procedures
    within context of Future of ICH
  • Most recent review in progress June 03 May
    2005 focus includes
  • selection of new topics business case now
    required
  • streamlining of procedures
  • clarifying roles and responsibilities
  • means of assessing implementation of guidelines
  • Transparency and communication

22
Transparency and Communication
  • Reviewing current practices at regional and ICH
    level
  • Options to be considered to strengthen
    transparency and communication
  • GCG seen as increasingly important mechanism for
    communication and engagement with non-ICH regions
    and parties

23
Global Cooperation Group (GCG)
  • Established March 1999 as sub-committee of ICH
    Steering Committee
  • Formed to respond to this growing interest in ICH
    guidelines
  • Name reflective of desire to establish links with
    non-ICH regions
  • Membership
  • 6 ICH parties
  • 2 Observers (WHO and Health Canada)
  • ICH secretariat

24
Initial Mandate
  • Initial focus on information-sharing
  • Soon became clear that more active engagement
    necessary to respond to increasing interest in
    ICH and ICH guidelines

25
Evolution In GCG Activities and Thinking
  • Series of joint meetings with regional
    representatives in preparation for ICH6 satellite
    session
  • Parallel discussions within GCG on need to be
    more relevant through establishing closer ties
    with regional harmonisation initiatives

26
Osaka, Nov. 2003 An Important Milestone
  • Endorsement by ICH SC of new Mandate and Terms of
    Reference that call for
  • the ongoing participation of regional
    harmonization initiatives
  • Greater transparency

27
Regional Harmonization Initiatives
  • APEC
  • Asia-Pacific Economic Cooperation
  • ASEAN
  • Association of the Southeast Asian Nations
  • GCC
  • Gulf Cooperation Council
  • PANDRH
  • Pan American Network for Drug Regulatory
    Harmonization
  • SADC
  • Southern African Development Community

28
PANDRH Representation
  • Initial selection during PANDRH Steering
    Committee meeting in Madrid (February 2005)
  • Dr. Carlos Chiale (ANMAT)
  • Dr. Davi Rumel (ANVISA)
  • Review scheduled for next Steering Committee
    meeting (March 2005)

29
GCG Meeting 16 November 2004, Yokohama, Japan
  • GCG Co-chairs
  • Dr. Yves Juillet (European Industry)
  • Mr. Mike Ward (Health Canada)

30
GCG Role and Procedures
  • Definition of GCG membership
  • Maximum of 2 permanent representatives per
    regional harmonization initiative
  • Representatives should solicit/present views of
    regional initiatives
  • Criteria for harmonization initiative to
    participate in GCG
  • GCG principles openness and transparency

31
GCG Reflections Paper Mission, Activities and
Operations of GCG
  • Issue While new terms of reference provide
    authority, tools and rules (the means), they do
    not define the mission of the new GCG (the ends)
  • Mission/vision necessary to guide and validate
    future activities

32
Considerations (1)
  • Moving beyond bounds of ICH
  • Serve as unique forum for harmonization
    initiatives to discuss
  • Best practices, lessons learned and innovative
    approaches to harmonization and regulation
  • ICH topics of interest
  • Technical guidelines beyond scope of ICH

33
Considerations (2)
  • Managing expectations resources, realistic
    objectives
  • GCG not a technical body
  • Funding issues
  • Stepwise approach build on successes

34
Draft Mission Statement
  • To promote a mutual understanding of regional
    initiatives in order to facilitate harmonisation
    processes related to ICH guidelines regionally
    and globally and to strengthen the capacity of
    drug regulatory authorities and industry to
    implement them.

35
Areas of work
  • ICH technical guidelines
  • Harmonization/regulation
  • Training and capacity building

36
Identified Topics of Interest
  • CTD implementation and e-submission
  • GCP implementation
  • E5 implementation
  • Pharmacovigilance guidelines and MedDRA
    implementation
  • Interest also expressed in
  • - technical assistance expressed
  • - review process and data assessment
  • - joint GCP inspections

37
Regional Meetings Identified
  • SADC January 05 implementation of ICH
    guidelines, including CTD
  • ASEAN February 05 pharmacovigilance

38
Next Steps Regional Input
  • Comments on draft ICH guidelines (Q8, S8, then
    Q9)
  • Proposals for pharmacovigilance plenary session
    (May 05)
  • Identification and presentation of guideline
    implementation and technical difficulties (formal
    presentations at GCG Brussels meeting)
  • GCG teleconference organized for April 7, 2005
  • Next GCG meeting May 10, 2005 in Brussels

39
Summary
  • ICH continues to balance development of important
    new topics with maintenance and implementation
    activities
  • New procedures and business case templates -
    meant to improve efficiency and value of ICH
    process
  • Transparency, communication and engagement
    through GCG seen as increasingly important
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