July and August have been busy months for FDA, EMA and Health Canada.

On July 15 the FDA’s CDER posted their 2026 guidance agenda.  The FDA uses this agenda to tell industry what guidance they plan to publish in 2026.

One of these new guidance documents is: Computer Software Assurance for AI-Based Systems in Drug Manufacturing and Clinical Investigations; Supplemental Guidance.

This document appears to be a separate document from the current draft guidance titled: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.

Some other planned guidance of interest to data managers include:

• Engaging with FDA to Discuss the Use of Digital Health Technologies in Clinical Investigations of Drug and Biological Products
• Master Protocols for Drug and Biological Product Development; Revised Draft4
• Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA Regulated Medical Products; Revised Draft

View CDER agenda here: https://acdmglobal.org/wp-content/uploads/2026/08/CDER-2026-Guidance-Agenda_07.2026.pdf

EMA continues their work to provide guidance on use of real-world data. This includes the creation of a Questions and Answers (Q and A) page. The Q and A page provides clarification on topics such as data quality, feasibility assessments and RWD source identification. View here: https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence#guidance-on-use-of-real-world-data-questions-and-answers-85590

Health Canada (HC) continues to publish new guidelines to support their modernization of the framework for clinical trials.  On August 14, 2026 HC published Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100).  GUI-0100 applies to any party involved in the conduct of clinical trials of drugs in human participants in Canada.  The guidance is meant to provide additional clarification to ICH E6, which HC adopted in April 2026.

The guidance specifies that “Health Canada has recognized a need to provide guidance in the interpretation of Part C, Division 5 of the Regulations, and specifically in terms of its relationship to ICH E6. This guidance document is intended to fulfill this need, as well as to provide additional guidance where is necessary or when ICH E6 does not apply.” The guidance includes sections on records retention and management, good clinical practices and serious unexpected adverse drug reaction reporting. You can view the guidance online or download a PDF document here.

It is also worth noting that in Dec 2025 Health Canada published their Draft guidance on decentralized clinical trials.  This is part of Health Canada’s effort to modernize clinical trial regulation to allow for new trial types and designs.  The guidance applies to phase I-IV trials involving pharmaceuticals, biologics and radiopharmaceuticals intended for human use.  It does not apply to medical devices, natural health projects or foods for special dietary purposes. You can view the draft guidance online. View the PDF.

The DMEG will be reviewing both Health Canada guidance documents in the next few weeks and evaluating the impact on data managers.