The International Council for Harmonization guidelines on Good Clinical Practices will be brought into effect by the European Medicines Agency on July 23, 2025.
The new guideline emphasizes proportionality more than the previous version two. Version two of the text stated that measures taken to manage quality and decrease risk should be proportionate to the challenges a study faces. Version three expands upon that idea by motivating sponsors to create trials that are fit for purpose and sufficient to give confidence in the trial’s results.
“Clinical trial processes and risk mitigation strategies implemented to support the conduct of the trial should be proportionate to the importance of the data being collected and the risks to trial participant safety and the reliability of trial results,” ICH said.
ICH has also introduced the concept of quality by design, which was absent from version two, and linked it to the pursuit of proportionality. Version three recommends sponsors implement quality by design “to identify the factors (i.e., data and processes) that are critical to ensuring trial quality and the risks that threaten the integrity of those factors and ultimately the reliability of the trial results.”
Sponsors need to identify the key factors in advance, as per ICH, and use them to guide a balanced and risk-based approach to quality management. The approach is part of a push to incorporate quality into the scientific and operational design and conduct of clinical trials.
The focus on proportionality and the introduction of quality by design were part of the for draft ICH released consultation in 2023. The draft text is unchanged in the final version. The two versions have been modified by adding sections that discuss how to handle informed consent and determine the level of investigator supervision for the drug.
Masuu Global offers expertise in the implementation of ICH GCP guidelines. With the European Medicines Agency set to enforce the updated ICH E6(R3) GCP guideline on July 23, 2025, Masuu Global will guide sponsors through risk-based quality management, proportionality, and quality-by-design strategies to ensure clinical trial success.