1. Michelle Limoli, Pharm.D.
Conference of the Pan American Network for Drug Regulatory Harmonization September 5, 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

2. 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

3. Three Regions, Six Parties
Europe
EU EFPIA
Japan
MHLW JPMA
United States of America
FDA PhRMA
Observers: Canada, EFTA, WHO
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in 1990.
It is a unique initiative involving both regulators and industry from the EU, Japan and the US as equal partners.

4. Monitors and Facilitates EWGs
Expert Working Groups
SAFETY EFFICACY
QUALITY REGULATORY
COMMUNICATIONS
STEERING COMMITTEE
Monitors and Facilitates EWGs

5. 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
The five steps the ICH process represent joint initiatives between regulators and industry and agreement between the European Union, Japan, and the USA. In the last decade, the ICH has published more than 50 guidelines in the areas of animal testing, drug quality, and clinical testing.
STEP 1--Building Scientific Consensus

6. 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

7. 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

8. 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

9. Evolution of ICH
Success of ICH and uptake of work products => catalyst for modifications:
Expanded participation
Outreach to other countries
Governance changes
Increased transparency

10. 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

11. 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)

12. 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

13. Expanded Participation
November 2005 RHIs invited to observe ICH Experts Working Group meetings. 13

14. 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

15. Expanded Participation
June 2008
Regulators from individual countries invited to ICH meeting and joined the Global Cooperation Group:
Australia India
Brazil Korea
China Russia
Chinese Taipei Singapore 15

16. 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

17. 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

18. Expanded Participation
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

19. 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

20. 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

21. Increased Transparency
November 2005 Decision to publish summary of SC actions and decisions (summarized report) on ICH website 21

22. 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

23. 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

24. 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

26. 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

27. Thank you for your attention