European Medicines Agency (EMA)

Annex 1 and Annex 2 has been published. The overarching principlesand Annex 1 adopted by ICH and CHMP came into effect on 23 July 2025. Annex 2 reached Step 4 following ICH adoption on 3 June 2026 and CHMP adoption on 25 June 2026 and will come into effect on 15 January 2027. ICH E6(R3) guideline builds on key concepts outlined in ICH E8(R1) Revision of General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning， using a proportionate risk-based approach.​ Keywords :Good clinical practice(GCP)。

pragmatic， sponsor， as well as those trials that incorporate real world data sources. The goal of Annex 2 is to offer GCP considerations for clinical trials with various design elements and data sources，clinical trials， investigator。

design，proportionality，。

statistics。

including its Appendices， ICH E6(R3)introduces innovative provisions designed to apply across various types and settings of clinical trials， and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials， is intended to provide information on how the principles can be appropriately applied to clinical trials.​ This Annex has been developed alongside the principles and objectives document to ensure consistency and to offer stakeholders a comprehensive package that can serve as a replacement for ICH E6(R2). Annex 2 covers designs such as pragmatic clinical trials and decentralized clinical trials， ethics committee， ensuring continued relevance in the face of ongoing technological and methodological advancements. This guideline provides a new language to facilitate innovations in clinical trial design， ICHE6(R3) ， trial design。

decentralised， safety reporting， technology。

clinical study/trial report， identifying factors critical to trial quality， and engaging interested parties， informed consent， real-world， promoting fit-for-purpose solutions. It fosters transparency through clinical trial registration and result reporting and offers additional guidance to enhance the informed consent process.​ To provide clarity and better readability ICH E6(R3) has a new structure and is composed of:​ An overarching principles and objectives document;​ Annex 1 (interventional clinical trials);​ Annex 2 (additional considerations for non-traditional interventional clinical trials).​​ The principles are intended to support efficient approaches to trial design and conduct. They are interdependent and should be considered in their totality to assure ethical trial conduct and reliable results.​ Annex 1 。

investigator's brochure， protocol， innovation， ensuring that they are fit for their intended purpose.​ This Annex should be read in conjunction with the Principles and Annex 1. A consolidated version of the principles， as appropriate。