ICH GUIDELINES                 1
Flow of presentation1   • Mission2   • History3   • Organization of ICH4   • Process of harmonization5   • ICH guidelines6...
What is ICH?"International Conference onHarmonisation of TechnicalRequirements for Registrationof Pharmaceuticals forHuman...
A Unique Approach• International Conference on Harmonisation  (ICH) was created in 1990• Agreement between the EU, Japan a...
Mission“make recommendations towards achievinggreater harmonisation in the interpretationand application of technical Guid...
Purpose of ICH• Harmonisation of technical requirements• Ensure safety, efficacy and quality of  medicines• Prevent duplic...
HistoryNeed to harmonise?  – Industry becoming global  – Duplicate test procedures     • Time consuming     • Expensive  –...
History contd…• Initiation of ICH  – 1980s: European Community  – 1989: WHO conference on Drug Regulatory    Authorities, ...
History contd…• Evolution of ICH     1990                   1999                                2004                      ...
Organisation of ICH                      10
ICH StructureRegion   Regulatory Body   Research Based IndustryJapan        MHLW                  JPMAEurope         EU   ...
Steering Committee                 WHO        Health                        EU        CanadaEFTA                          ...
Global Cooperation Group• Formed in 1999• Sub-committee of SC• Participants:  – APEC  – ASEAN  – EAC  – GCC  – PANDRH  – S...
GCG Contd…• Expansion of GCG: 2007  – Australia  – Brazil  – China  – Chinese Taipei  – India  – Korea  – Russia  – Singap...
MedDRA Management Board• Oversees the activities of the MedDRA  “Maintenance and Support Services  Organisation” (MSSO)• M...
Secretariat– Located in Geneva– Working of ICH               Coordinators– Smooth running of ICH– Nominated by each of 6 p...
ICH Working Groups• EWG: developing a harmonised guideline that  meets the objectives in the Concept Paper and  Business P...
Process of Harmonisation• 4 categories:  1.   Formal ICH Procedure  2.   Q&A Procedure  3.   Revision Procedure  4.   Main...
Formal ICH ProcedureConsensus building    Confirmation of 6 party consensus        Regulatory consultation and discussion ...
WorkProducts       20
Work Products1.   ICH Guidelines2.   MedDRA3.   CTD4.   Electronic Standards5.   Consideration Documents6.   Open Consulta...
ICH Guidelines  • Stability  • Impurities testing  • GMP  • Carcinogenicity  • Genotoxicity  • Reprotoxicity  • Clinical t...
MedDRA• Medical dictionary of regulatory activities• Prepared by ICH and owned by IFPMA• Used for registration, documentat...
CTD      24
Benefits of ICH Process•   More than 50 harmonised guidelines•   Streamline R&D process•   Rapid access to new medicines• ...
Concerns about ICH• Non-ICH members not considered in the  decision making process• Lack of sufficient consultation with a...
Future• The continued success and relevance of ICH  will in large part depend on a much broader  use of ICH guidelines and...
Future Contd…• More important role of WHO and non-ICH  members in the decision making process• Recognition of challenges f...
“If you want to go fast, go alone. Ifyou want to go far, go together”                                    29
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ICH GUIDELINES

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  1. 1. ICH GUIDELINES 1
  2. 2. Flow of presentation1 • Mission2 • History3 • Organization of ICH4 • Process of harmonization5 • ICH guidelines6 • Benefits and concerns of ICH7 • Future 2
  3. 3. What is ICH?"International Conference onHarmonisation of TechnicalRequirements for Registrationof Pharmaceuticals forHuman Use" 3
  4. 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. 5. Mission“make recommendations towards achievinggreater harmonisation in the interpretationand application of technical Guidelines andrequirements for pharmaceutical productregistration” 5
  6. 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. 7. HistoryNeed to harmonise? – Industry becoming global – Duplicate test procedures • Time consuming • Expensive – Increasing R&D costs – Meeting public demand 7
  8. 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. 9. History contd…• Evolution of ICH 1990 1999 2004 2008 ICH GCG RHI Expanded GCG 9
  10. 10. Organisation of ICH 10
  11. 11. ICH StructureRegion Regulatory Body Research Based IndustryJapan MHLW JPMAEurope EU EFPIA US FDA PhRMA 11
  12. 12. Steering Committee WHO Health EU CanadaEFTA EFPIAIFPMA MHLW PhRMA JPMA FDA 12
  13. 13. Global Cooperation Group• Formed in 1999• Sub-committee of SC• Participants: – APEC – ASEAN – EAC – GCC – PANDRH – SADC 13
  14. 14. GCG Contd…• Expansion of GCG: 2007 – Australia – Brazil – China – Chinese Taipei – India – Korea – Russia – Singapore 14
  15. 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. 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. 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. 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. 19. Formal ICH ProcedureConsensus building Confirmation of 6 party consensus Regulatory consultation and discussion Adoption of ICH harmonised tripartite guideline Implementation 19
  20. 20. WorkProducts 20
  21. 21. Work Products1. ICH Guidelines2. MedDRA3. CTD4. Electronic Standards5. Consideration Documents6. Open Consultations 21
  22. 22. ICH Guidelines • Stability • Impurities testing • GMP • Carcinogenicity • Genotoxicity • Reprotoxicity • Clinical trials • Pharmacogenomics • MedDRA • CTD • Electronic Standards 22
  23. 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. 24. CTD 24
  25. 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. 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. 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. 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. 29. “If you want to go fast, go alone. Ifyou want to go far, go together” 29
  30. 30. 30

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