Process of Harmonization

The ICH harmonization process follows a structured five-step approach:

Step 1: Consensus Building:

• Experts from different regions discuss and draft a harmonized guideline.

Step 2: Official Draft:

• The draft is approved by the ICH Steering Committee.

Step 3: Regulatory Consultation:

• Public and regulatory authorities review and comment on the draft.

Step 4: Final Adoption:

• The guideline is formally adopted by regulatory bodies.

Step 5: Implementation:

• Countries incorporate the guideline into their regulatory framework.

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