OVERVIEW OF ICH GUIDELINES

1. ICH GUIDELINES
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2. Flow of presentation
1 • Mission
2 • History
3 • Organization of ICH
4 • Process of harmonization
5 • ICH guidelines
6 • Benefits and concerns of ICH
7 • Future
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3. What is ICH?
"International Conference on
Harmonisation of Technical
Requirements for Registration
of Pharmaceuticals for
Human Use"
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4. 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
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5. Mission
“make recommendations towards achieving
greater harmonisation in the interpretation
and application of technical Guidelines and
requirements for pharmaceutical product
registration”
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6. Purpose of ICH
• Harmonisation of technical requirements
• Ensure safety, efficacy and quality of
medicines
• Prevent duplication of clinical trials in humans
• Minimize the use of animal testing without
compromising safety and effectiveness
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7. History
Need to harmonise?
– Industry becoming global
– Duplicate test procedures
• Time consuming
• Expensive
– Increasing R&D costs
– Meeting public demand
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8. History contd…
• Initiation of ICH
– 1980s: European Community
– 1989: WHO conference on Drug Regulatory
Authorities, Paris
– 1990: Birth of ICH, Brussels
• Europe
• Japan
• US
– Topics for harmonisation divided into: Safety,
Efficacy and Quality
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9. History contd…
• Evolution of ICH
1990
1999
2004
2008
ICH GCG RHI Expanded
GCG
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10. Organisation of ICH
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11. ICH Structure
Region Regulatory Body Research Based Industry
Japan MHLW JPMA
Europe EU EFPIA
US FDA PhRMA
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12. Steering Committee
WHO
Health
EU
Canada
EFTA EFPIA
IFPMA MHLW
PhRMA JPMA
FDA
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13. Global Cooperation Group
• Formed in 1999
• Sub-committee of SC
• Participants:
– APEC
– ASEAN
– EAC
– GCC
– PANDRH
– SADC
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14. GCG Contd…
• Expansion of GCG: 2007
– Australia
– Brazil
– China
– Chinese Taipei
– India
– Korea
– Russia
– Singapore
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15. MedDRA Management Board
• Oversees the activities of the MedDRA
“Maintenance and Support Services
Organisation” (MSSO)
• Members:
– EU
– EFPIA
– MHLW
– JPMA
– FDA
– PhRMA
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16. Secretariat
– Located in Geneva
– Working of ICH
Coordinators
– Smooth running of ICH
– Nominated by each of 6 parties
– Acts as the main contact point with the ICH
Secretariat
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17. ICH Working Groups
• EWG: developing a harmonised guideline that
meets the objectives in the Concept Paper and
Business Plan
• IWG: develop Q&As to facilitate
implementation of existing guidelines
• InWG: developing/finalizing a Concept Paper,
as well as developing a Business Plan
• DG: discuss specific scientific considerations or
views
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18. Process of Harmonisation
• 4 categories:
1. Formal ICH Procedure
2. Q&A Procedure
3. Revision Procedure
4. Maintenance Procedure
• Each harmonisation activity is initiated by a
Concept Paper and a Business Plan
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19. Formal ICH Procedure
Consensus building
Confirmation of 6 party consensus
Regulatory consultation and discussion
Adoption of ICH harmonised tripartite
guideline
Implementation
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20. Work
Products
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21. Work Products
1. ICH Guidelines
2. MedDRA
3. CTD
4. Electronic Standards
5. Consideration Documents
6. Open Consultations
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22. ICH Guidelines
• Stability
• Impurities testing
• GMP
• Carcinogenicity
• Genotoxicity
• Reprotoxicity
• Clinical trials
• Pharmacogenomics
• MedDRA
• CTD
• Electronic Standards
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23. MedDRA
• Medical dictionary of regulatory activities
• Prepared by ICH and owned by IFPMA
• Used for registration, documentation and
safety monitoring of medical products
• MSSO is responsible to maintain, develop and
distribute MedDRA
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24. CTD
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25. Benefits of ICH Process
• More than 50 harmonised guidelines
• Streamline R&D process
• Rapid access to new medicines
• Benefits for the regulators
• Reference and educational material for non-
ICH members
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26. Concerns about ICH
• Non-ICH members not considered in the
decision making process
• Lack of sufficient consultation with academic
scientists, health professionals and patient
groups
• Role of WHO
• Role of IFPMA
• Implications in developing countries
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27. Future
• The continued success and relevance of ICH
will in large part depend on a much broader
use of ICH guidelines and standards
• Expanded participation in the development
and implementation of ICH products will play
a key role in promoting a more globally
consistent approach to drug development and
oversight
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28. Future Contd…
• More important role of WHO and non-ICH
members in the decision making process
• Recognition of challenges faced by developing
countries trying to use ICH guidelines
• As more countries embrace ICH guidelines,
promotion of a common regulatory language
will facilitate further interactions among
global drug regulatory authorities
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29. “If you want to go fast, go alone. If
you want to go far, go together”
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