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1 OA ICH Background
The document discusses the importance of harmonization in pharmaceutical regulatory sciences, emphasizing the need for regulations to ensure the safety, efficacy, and quality of drugs amidst globalization and increasing complexity. It highlights the role of the International Conference on Harmonization (ICH) in streamlining drug registration processes between the US, EU, and Japan while identifying the value of collaboration and transparency in regulatory practices. The document also concludes with a vision for continued global cooperation and the evolution of guidelines to cater to emerging scientific advancements.
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1 OA ICH Background
- 1. ICH, Globalization &Drive of Pharmaceutical Regulatory Sciences Dr. Obaid Ali Civil Service Officer, Member, ISPE, PDA 26 March 2017
- 2. Not the view of DRAP Current judgment No obligation onDRAP Regulatory experience D I S C L A I M E R References US-FDA WHO ICH NRAs
- 3. Lets think What willhappen if Pharmaceutical Industry does not exist or stop working in world?
- 4. Who Cares? It isPharmaceutical Industry … Science … Research ..
- 5. Safe, efficacious &have correct identity Deliver the same performance as claimed Perform consistently over shelf life Made in a manner that ensure quality Will be available when needed Patient and Doctor assume that Drugs are
- 6. Lets think What willhappen if Pharmaceutical Industry is not regulated in the world?
- 8. Typically Consumer Cannot see Quality
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- 10. Pre Market Manufacturing & Supply PostMarket Translational Science
- 12. Constitution Act Regulations PoliciesInitiatives
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- 16. Emerging Science &Innovation Increasing Disease Burden Expanding Regulatory Complexity
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- 20. Unique Approach International Conferenceon Harmonization (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
- 21. ICH Philosophy Identification andelimination of the need to duplicate studies to meet different regulatory requirements More efficient use of resources in the R&D process, as a consequence Quicker access for patients to safe and effective new medicines
- 22. Lets align andkeep it clear …. that ICH is neither a forum of global politics nor a trade negotiation, but a scientific forum mainly covers “new drugs” guidelines provide “how to collect data scientifically for marketing authorization”
- 23. Step by StepMoving Approach Regulatory Implementation Adoption of GL by Regulators/Publishing ICH GL Regulatory Consultation/Consolidation of Comments SC Agrees to Releasing Draft GL Consensus Building/Drafting of GL
- 24. Working Groups Safety EfficacyQuality Multidisciplinary Steering Committee Endorses topics, guidelines, and monitors progress
- 25. The way leadingAgencies work 1 • Amending Existing GLs 2 • Issuing New GLs 3 • Law Amendment Formal Vehicles Q&A Seminars Publications Etc.
- 26. Implementation Process Flow TopicSelection Dissemination Publication Training Implementation Management Good guideline topic selection Formal communication process Active distribution Educating users Putting guideline „theory‟ into „practice‟ Active monitoring of utilization Guideline must be value- added and ‘implementable’ Use multiple avenues Targeted; via meetings; also to non-ICH groups ‘Early, often, all’; within and across organizations Integrated process; address questions/issues Feedback to ICH SC Implementation StepProcess Actions
- 28. A „mature‟ harmonizationinitiative A series of technical guidelines emerging, a dictionary of medical terms, electronic standards and a common format Multiple ICH conferences Witnessing increased interest in and use of ICH guidelines globally Formation and evolution of Global Cooperation Group (GCG) ICH Today
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- 30. Following over a decadeof significant achievements in the harmonization of Q, S, E requirements for the registration of new drugs in the three ICH regions, Is the work of ICH mostly done? Will ICH become a maintenance-only organization?
- 31. Proper balance b/wmaintenance and new activities New topics of high value & objectives are achievable Most efficient use and management of resources Flexible enough to deal evolving science/technologies ….. More transparent Appropriate time to evaluate the future of ICH to ensure: NO
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- 34. Opening new Horizonscontinued • Review Current Practice at regional and ICH level • Options Strengthen transparency and communication • GCG Communicat ion & engagement with non- ICH regions & parties
- 35. Global Cooperation Group EstablishedMarch 1999 as sub- committee of ICH Steering Committee Formed to respond to this growing interest in ICH guidelines Name reflective of desire to establish links with non-ICH regions InformationSharing JointMeetings
- 36. Regional Harmonization Initiatives APECASEAN GCC PANDRH SADC A Bridge from ICH to the world beyond Openness and Transparency
- 37. Yesterday Dream isa Reality Today Moving beyond bounds of ICH Serve as unique forum for harmonization initiatives to discuss Best practices Lessons learned Innovative approaches to harmonization and regulation
- 38. Road where trafficis moving ahead ICH technical guidelines Harmonization/ regulation Training and capacity building
- 39. There is noharm to have a Dream One world One patient One drug One quality One time
- 40. Harmonization & JointWorking Initiatives I G D R P
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- 43. Harmonization & JointWorking Initiatives P I C S
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- 45. Membership of Pharmaceutical InspectionCo-operation Scheme (PIC/S) A gate way towards best protection and promotion of public health and Pharmaceutical industries
- 46. Purpose Cooperation …mutual confidence Exchange of information & experience Mutualtraining & Technical Expertise Improvement & Harmonization Continuity of common efforts for GMP Equivalent standard for global harmonization
- 47. Closing Message We canbe blind to the obvious, and we are also blind to our blindness Daniel Kahneman