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Process of Harmonisation
- About ICH
ICH harmonisation activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision Procedure and Maintenance Procedure, depending on the activity to be undertaken (see below).
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New topic for harmonisation of ICH?
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Concept Paper & Business Plan required
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Clarification needed for an existing ICH Guideline?
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Concept Paper required (Business Plan may be required in certain cases)
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Content of an existing ICH Guideline out of date or no longer valid?
New information to be added to an existing ICH Guideline?
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Concept Paper required
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Change to be made to elther Q3C Guideline or M2 Recommendations?
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Proposal/Concept Paper required for Q3C maintenance. No Concept Paper required for M2 Recommendations maintenance
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Each harmonisation activity is initiated by a Concept Paper which is a short summary of the proposal. Depending on the category of harmonisation activity a Business Plan may also be required. The Business Plan outlines the costs and benefits of harmonising the topic proposed by the Concept Paper.
Only when the ICH Steering Committee endorses a Concept Paper, and where appropriate a Business Plan, can the harmonisation activity be initiated.
Celebration
Two decades of groundbreaking work in harmonising