Steps in the ICH Process for Guideline Development

Step 1 - Consensus Building Step 2 - a. ICH Parties consensus on Technical Document b. Draft guideline adoption by regulators - Endorsement by A. assembly, B. regulators Step 3 - Regulatory consultation and discussion - Sign-off by regulatory topic leaders Step 4 - Adoption of an ICH Harmonised Guideline - Adoption by regulators Step 5 - Implementation