ICHGuideline.docVIP

Quality Guidelines? In November 2005, the ICH Steering Committee adopted a new codification system for ICH Guidelines.? The purpose of this new codification is to ensure that the numbering / coding of ICH Guidelines is more logical, consistent and clearer.? Because the new system applies to existing as well as new ICH Guidelines a history box has been added to the beginning of all Guidelines to explain how the Guideline was developed and what is the latest version. 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 and 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. ?New Codification as per November 2005?Previously coded: StabilityQ1A(R2) HYPERLINK /cache/compo/363-272-1.html \l Q1A(R2)#Q1A(R2) Stability Testing of New Drug Substances and ProductsQ1A(R2)Q1B HYPERLINK /cache/compo/363-272-1.html \l Q1B#Q1B Stability Testing : Photostability Testing of New Drug Substances and ProductsQ1BQ1C HYPERLINK /cache/compo/363-272-1.html \l Q1C#Q1C Stability Testing for New Dosage FormsQ1CQ1D HYPERLINK /cache/compo/363-272-1.html \l Q1D#Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsQ1DQ1E HYPERLINK /cache/compo/363-272-1.html \l Q1E#Q1E Evaluation of Stability DataQ1EQ1F HYPERLINK /cache/compo/363-272-1.html \l Q1F#Q1F Stability Data Package for Registration Applications in Climatic Zones III and IVQ1FAnalytical ValidationQ2(R1)New title:  HYPERLINK /cache/compo/363-272-1.htm