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ICH GUIDELINES
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.
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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 2
- 3. What is ICH? "InternationalConference 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 towardsachieving 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… • Initiationof 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… • Evolutionof ICH 1990 1999 2004 2008 ICH GCG RHI Expanded GCG 9
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- 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… • Expansionof 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 inGeneva – 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 Consensusbuilding Confirmation of 6 party consensus Regulatory consultation and discussion Adoption of ICH harmonised tripartite guideline Implementation 19
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- 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 dictionaryof 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 ICHProcess • 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 continuedsuccess 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… • Moreimportant 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 wantto go fast, go alone. If you want to go far, go together” 29
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