ICH GUIDELINES
1. ICH GUIDELINES 1
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 2
3. What is ICH? "International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use" 3
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 4
5. Mission “make recommendations towards achieving greater
harmonisation in the interpretation and application of technical Guidelines and
requirements for pharmaceutical product registration” 5
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 6
7. History Need to harmonise? – Industry becoming global – Duplicate test
procedures • Time consuming • Expensive – Increasing R&D costs – Meeting
public demand 7
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 8
9. History contd… • Evolution of ICH 1990 1999 2004 2008 ICH GCG RHI
Expanded GCG 9
10. Organisation of ICH 10
11. ICH Structure Region Regulatory Body Research Based Industry Japan
MHLW JPMA Europe EU EFPIA US FDA PhRMA 11
12. Steering Committee WHO Health EU Canada EFTA EFPIA IFPMA MHLW
PhRMA JPMA FDA 12
13. Global Cooperation Group • Formed in 1999 • Sub-committee of SC •
Participants: – APEC – ASEAN – EAC – GCC – PANDRH – SADC 13
14. GCG Contd… • Expansion of GCG: 2007 – Australia – Brazil – China –
Chinese Taipei – India – Korea – Russia – Singapore 14
15. MedDRA Management Board • Oversees the activities of the MedDRA
“Maintenance and Support Services Organisation” (MSSO) • Members: – EU –
EFPIA – MHLW – JPMA – FDA – PhRMA 15
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 16
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 17
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 18
19. Formal ICH Procedure Consensus building Confirmation of 6 party
consensus Regulatory consultation and discussion Adoption of ICH harmonised
tripartite guideline Implementation 19
20. Work Products 20
21. Work Products 1. ICH Guidelines 2. MedDRA 3. CTD 4. Electronic Standards
5. Consideration Documents 6. Open Consultations 21
22. ICH Guidelines • Stability • Impurities testing • GMP • Carcinogenicity •
Genotoxicity • Reprotoxicity • Clinical trials • Pharmacogenomics • MedDRA •
CTD • Electronic Standards 22
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 23
24. CTD 24
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 25
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 26
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 27
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 28
29. “If you want to go fast, go alone. If you want to go far, go together” 29
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