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ICH/EMA – ICH E6 (R3) Guideline for good clinical practice (GCP) has reached Step 5

ICH E6(R3) introduces innovative provisions designed to apply across various types and settings of clinical trials, 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, technology, and operational approaches. It encourages a risk-based and proportionate approach to conducting clinical trials, 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.

The third revision of the ICH E6(R3) GCP Guideline has been adopted the 12 December 2024 and will come into effect the 23 July 2025.

More information on the ICH E6 Guideline, including previous versions, on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (25 mars 2025). ICH/EMA – ICH E6 (R3) Guideline for good clinical practice (GCP) has reached Step 5. ELSIBI. Consulté le 15 mars 2026 à l’adresse https://doi.org/10.58079/13kga


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