Transcript Lessons Learned - Michele Limoli - US FDA

Conference of the Pan American Network for
Drug Regulatory Harmonization
September 5, 2013
Overview of ICH Governance:
Lessons Learned
Michelle Limoli, Pharm.D.
International Programs/OSP
Center for Drug Evaluation and Research
US Food and Drug Administration
The views expressed in this presentation are those of the author and do not
necessarily represent the views of the U.S. Food and Drug Administration
ICH: A Unique Approach
• ICH was created in 1990
• Agreement between the European Union,
Japan and the United States to harmonize
technical requirements for registration of
pharmaceuticals for human use
• Joint effort by regulators and associated
trade associations
Three Regions, Six Parties
Europe
EU
EFPIA
Japan
MHLW
JPMA
United States of America
FDA
PhRMA
Observers: Canada, EFTA, WHO
Expert Working Groups
SAFETY
QUALITY
EFFICACY
REGULATORY
COMMUNICATIONS
STEERING COMMITTEE
Monitors and Facilitates EWGs
Steps of ICH Harmonization
STEP 5--Implementing
Guidelines in ICH Regions
STEP 4--Adopting
Harmonized Guidelines
STEP 3--Consulting Regional
Regulatory Agencies
STEP 2--Agreeing on Draft Text
STEP 1--Building Scientific Consensus
Steering Committee
• Governs ICH
• Determines ICH policies, procedures and
direction
• Decides on adoption of new
topics/projects
• Monitors & facilitates progress of Expert
Works Groups (EWGs)
• Signs off ICH documents
ICH Products
•
•
•
•
•
60 Guidelines on technical requirements:
Quality - 21 Guidelines
Safety - 14 Guidelines
Efficacy - 20 Guidelines
Multidisciplinary - 5 Guidelines
•
Electronic Standards for the Transfer of Regulatory Information
(ESTRI, E2B)
Common Technical Document (CTD & eCTD)
Medical dictionary for adverse event reporting and coding of clinical
trial data (MedDRA)
Consideration documents
•
•
•
Keys to ICH Success:
• Well-defined process and procedures
• Effective management and administration
(permanent Secretariat)
• Limited number of participants with common
focus
• Science-based and consensus driven
• Frequent, concurrent meetings of SC and WGs
that are outcomes based
• Comparable regulatory, technical and financial
capacity
• Commitment of all parties to implementation
Evolution of ICH
Success of ICH and uptake of work products
=> catalyst for modifications:
•
•
•
•
Expanded participation
Outreach to other countries
Governance changes
Increased transparency
Expanded Participation
May 1996
• Generic industry experts included in
Quality Expert Working Groups (EWGs)
• OTC industry experts included in Quality
and appropriate Efficacy topics EWGs
10
Expanded Participation
November 2003
Regional Harmonization Initiatives (RHIs)
invited to ICH mtg & included in the Global
Cooperation Group
•
•
•
•
•
•
APEC
ASEAN
GCC
PANDRH
SADC
EAC (2011)
11
Expanded Participation
May 2005
Definition of Interested Parties created
(those that regulate by or are regulated by
ICH guidelines) to assure that they were
included in appropriate ICH discussions and
EWG meetings.
(OTC, generics, API, biotech industry)
12
Expanded Participation
November 2005
RHIs invited to observe ICH Experts
Working Group meetings.
13
Expanded Participation
October 2006
SC Decides to collaborate with Standards
Development Organizations (SDOs) to take
advantages of their open, consensus based
process in the development of electronic
standards associated with the eCTD
14
Expanded Participation
June 2008
Regulators from individual countries invited
to ICH meeting and joined the Global
Cooperation Group:
Australia
Brazil
China
Chinese Taipei
India
Korea
Russia
Singapore
15
Expanded Participation
April 2011
ICH SC opens Expert Working Groups to
RHIs, DRAs, DoH as expert members (not
only as observers), with following criteria:
– Demonstrated support for the use of ICH guidelines
– Experts possess appropriate knowledge
– Commitment to participate in all discussions over life
of topic development
– Self-financed travel
16
Expanded Participation
June 2013
The ICH Global Cooperation Group was
integrated into sessions of the ICH Steering
Committee in order to promote greater
involvement of global regulators.
17
Expanded Participation
2013 - Ongoing
The ICH SC is currently discussing options
to increase the opportunity for more active
engagement of regulators & industry
stakeholders beyond the “founding” regions:
• Preserving/increasing the efficiency & accountability of
ICH process
• Controlling costs
• Increasing transparency of the process
18
Revised Governance
June 2012
ICH SC creates new Regulatory Chair
position for EWGs, to ensure regulatory
oversight & integrity of the entire process:
•
•
•
•
Must be from a regulatory ICH party
Oversees EWG work at Steps 1-4
Monitors timeframes, scope adherence and process
Work closely with Rapporteur and reports to the SC
19
Revised Governance
June 2012
In order to better define the roles of the
regulatory and industry parties, the SC
revised the harmonization process by
separating Step 2 into Step 2a & Step 2b.
This distinguishes and separates technical
standards work from regulatory policy
decisions.
20
Increased Transparency
November 2005
Decision to publish summary of SC actions
and decisions (summarized report) on ICH
website
21
Increased Transparency
June 2006
SC decides to post Concept Papers and
Business Plans for all new ICH topics. This
provided for earlier notice of new topics
under discussion (instead of at Step 3 when
documents were posted for public comment)
22
Increased Transparency
June 2013
SC decides to post on the ICH website:
• Agenda
• Report of SC meetings
• Work plans of active EWGs
• ICH Procedures document
23
Increased Transparency
• Newly revised ICH Website
– User Friendly
– All guidelines, draft & final, press releases, meeting information
– Educational modules
• Anyone can comment on ICH Guidelines
–
–
–
–
ICH Website
PANDRH rep
ICH Coordinators
Public Consultations
• Help to Shape the ICH Guidelines
24
www.ich.org
Continuing Evolution of ICH
• Given the global environment in which we now
operate, the continued success & relevance of
ICH will depend upon broader use of ICH
guidelines and standards
• ICH must evolve to meet the changing global
paradigm
• Expanded participation in ICH is expected to
benefit, industry, regulators and patients
• => Faster access to innovative medicines
Thank you
for your
attention