Regulatory Considerations DMEG Update – June 2026
Date: June 25, 2026
Please read the following update from the Regulatory Considerations DMEG:
Regulators have been busy in 2026. Several new publications and initiatives reinforce expectations for quality, oversight, and data reliability across traditional clinical trials, decentralized and pragmatic trial approaches, and trial strategies that include real-world data (RWD) and Artificial Intelligence (AI).
As a result, the ACDM’s Data Management Expert Group (DMEG) has also been busy. The DMEG focuses on regulatory considerations for data managers. Our DMEG reviews new guidelines, position statements, and guidance documents to assess their impact on data management activities. Our recent reviews include the MHRA’s Clinical Trials for Medicines: Guidance on Quality and Risk Proportionality.
Between December 2025 and March 2026, the Medicines and Healthcare Products Regulatory Agency (MHRA) released multiple guidance documents supporting its update to the Clinical Trials Regulations.
Our DMEG reviewed the most recent release, “Clinical trials for medicines: guidance on quality and risk proportionality”, effective as of April 28, 2026, and identified areas specifically impacting datamanagers. Main points include applying Good Clinical Practice (GCP), evaluating the proportionality of quality and risk, retaining records, and annotating ICH E6 and ICH E8. DMEG has published these highlights and impact assessments on the ACDM DMEG website. A link to the ACDM DMEG website is available here: https://acdmglobal.org/regulatory-considerations-dmeg/
ICH released ICH E6 R3 Annex 2 on June 3, 2026. The DMEG will be reviewing Annex 2 in detail. Followingour review, we will publish a summary of the key considerations for data management, along with an impact assessment, on the ACDM DMEG website. In the meantime, we are sharing the published document for awareness. You can access the document using the link below and read about expectations that may apply to data managers when decentralized elements, pragmatic components, or real-world data (RWD) are incorporated into clinical research: https://lnkd.in/eqG4wxWR
The DMEG frequently monitors regulatory publications related to AI. The FDA’s draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” remains in draft form and has not yet been issued as a final version; however, this area is evolving.
In January 2026, the FDA and EMA also published their joint “Guiding Principles of Good AI Practice in Drug Development” guidance. This document draws attention to the need for human-centric design, governance, life-cycle management, and risk-based performance assessment as essential principles for the responsible use of AI in drug development.
Our DMEG will continue to monitor regulatory updates in the AI space and share pertinent updates.
