The International Conference on Harmonisation (ICH) was created in 1990 as a unique effort between regulators and industry from the EU, Japan, and US to harmonize technical requirements for pharmaceutical registration. ICH aims to ensure safety, efficacy, and quality of medicines while preventing duplicative trials and minimizing animal testing. Through guidelines developed via consensus building among members, ICH has harmonized requirements for drug development and approval processes. However, some concerns remain regarding inclusion of non-members in the decision making and implications for developing countries.

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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