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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
- 30. 30