With the new codification revisions to an ICH Guideline are shown as (R1), (R2), (R3) depending on the number of revisions. Annexes or Addenda to Guidelines have now been incorporated into the core Guidelines and are indicated as revisions to the core Guideline (e.g., R1).
For implementation reasons, the Regulatory Authorities working within the ICH Regions (European Commission, Food band Drug Administration and Ministry of Health, Labor and Welfare) may not change the codification retrospectively.
The tables below are intended to clarify the old/new ICH Guidelines codification, with effect November 2005.
IRB Submission Creteria