The ICH E6(R3) Guideline reaches Step 4 of the ICH Process

The ICH E6(R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. The guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. The Guideline comprises of Principles and Annexes that expand on the principles, with specific details for different types of clinical trials. The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial. Annex 1, including its Appendices, is intended to provide information on how the Principles can be appropriately applied to clinical trials.

Additional annexes may be developed to respond to interested parties' needs and address emerging innovations in trial design and conduct. This guideline should be read in conjunction with other ICH guidelines relevant to the design and conduct of clinical trials, including multiregional trials. 

Pls download click here:https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf

plastic pharmaceutical packaging