The FDA ICH M15 guidance sets out harmonised principles for model-informed drug development, known as MIDD, and the US Food and Drug Administration scheduled a stakeholder webinar on it for 29 October 2026. The International Council for Harmonisation adopted the guideline in February 2026, and the FDA implemented it in June 2026 by issuing final guidance. The webinar was designed to explain the concepts, work through a case example and gather feedback. This explainer covers what the guidance is, who it affects, what the FDA has said and what we do not yet know about the discussion.
FDA ICH M15 guidance: key takeaways
- ICH adopted M15, General Principles for Model-Informed Drug Development, in February 2026.
- The FDA implemented it in June 2026 as final guidance.
- It gives general recommendations for planning, evaluating and documenting evidence from model-informed drug development.
- A free virtual webinar for stakeholders was scheduled for 29 October 2026, 8:30 to 10:00 a.m. ET, with no registration required.
- The webinar was to explain concepts, work through a case example, answer common questions and gather feedback for training materials.
What the FDA ICH M15 guidance covers
Model-informed drug development uses mathematical and statistical models, such as those describing how a drug moves through the body or how dose relates to effect, to support decisions in development and regulatory review. According to the FDA, M15 gives general recommendations on planning, model evaluation and documenting evidence, and it sets a harmonised assessment framework with shared terminology. The aim is for sponsors and regulators in different regions to use common language and expectations. The final document is available from the FDA, and the International Council for Harmonisation publishes the harmonised guideline.
The FDA ICH M15 guidance webinar: what was planned
The FDA’s event page lists the webinar as a virtual webcast streamed on YouTube, free of charge and without registration. Its stated objectives are to explain the concepts in the final guideline, to encourage timely adoption to streamline drug development and regulatory interactions, to answer common questions about applying the principles, and to gather feedback to help develop further training materials and case examples. Pre-recorded presentations are described as coming soon. The page names no individual speakers, and we have not seen a report of what was said in the session, so we do not describe its content. Details are on the FDA webinar page.
Who is affected by the FDA ICH M15 guidance
Pharmacometricians, clinical pharmacologists, statisticians, regulatory-affairs teams and drug developers are the main audiences. Companies that submit models as part of applications, or use them to justify doses, trial designs or populations, would be expected to consider the framework. The guidance is not a law, but FDA guidance documents describe the agency’s current thinking. Teams outside the United States should check how their own regulators have implemented the ICH text. See our Pharmaceutical coverage.
Common uses of models behind the FDA ICH M15 guidance
In general terms, models are used to choose starting doses for first-in-human studies, to predict how a drug behaves in children or in people with kidney or liver impairment, to test whether a trial design has enough statistical power, and to explore how different dosing schedules might perform. They can also help interpret drug interactions. These examples describe the field broadly and are not drawn from the M15 text, which we have summarised only as the FDA describes it. The shared framework is intended to make the planning and evaluation of such work more consistent.
Why the FDA ICH M15 guidance matters for development
Models can reduce uncertainty when trials are small or difficult, for example by supporting dose selection or extrapolation to different populations. A shared framework can reduce back-and-forth with regulators if everyone agrees how model evidence should be planned, assessed and documented. The practical effect depends on how consistently agencies apply it, which will only become clear through experience. This is a general reading of the stated aims and not a prediction of regulatory outcomes.
How the FDA ICH M15 guidance fits wider regulatory science
Regulators have been encouraging the use of quantitative methods for years, including through programmes that let sponsors discuss modelling approaches with the agency. M15 adds a common international reference to that effort. It sits alongside other ICH guidelines that cover quality, safety, efficacy and multidisciplinary topics, and it will be read together with them. The FDA page does not discuss how M15 interacts with specific programmes, so we do not describe those links.
Market context from Acumen Research and Consulting
Acumen Research and Consulting’s Computer-Aided Drug Discovery Market report is related context and not a measure of MIDD itself. It values that market at USD 2,845 million in 2021 and projects USD 7,232 million by 2030, a CAGR of 11.3% for 2022 to 2030. The growth implied by those endpoints is about 10.9% a year by our own calculation, so the figures do not fully match. The page was last updated in June 2022, so the numbers may be out of date.
Timeline of the FDA ICH M15 guidance
- February 2026: ICH adopts M15.
- June 2026: FDA implements the final guidance.
- 29 October 2026: stakeholder webinar scheduled.
- Not dated: pre-recorded presentations and further training materials.
General background: what a model does in drug development
A pharmacokinetic model describes how concentration changes over time, and an exposure-response model links concentration to effect or side effects. These tools help choose doses and design trials but depend on assumptions and data quality.
Our analysis of the FDA ICH M15 guidance
In our assessment, the FDA ICH M15 guidance webinar is part of a rollout: the guidance exists, and the agency is now helping the community apply it. The value will show in clearer submissions and fewer disputes about model evidence, which will take time to observe.
What is not disclosed about the FDA ICH M15 guidance webinar
- Speakers and the content of the live discussion.
- The case example to be worked through.
- Dates for the pre-recorded presentations.
Risks and caveats
This article is based on the FDA’s event page and published guidance information, not on the webinar itself. It is news reporting and not regulatory or legal advice.
What to watch next for the FDA ICH M15 guidance
- Release of pre-recorded presentations.
- Additional case examples.
- Implementation by other regulators.
FAQ
What is ICH M15?
A harmonised guideline on general principles for model-informed drug development.
When did the FDA implement it?
In June 2026.
Was registration needed for the webinar?
No. It was free, with no registration required.
How we reported this: we relied on the FDA event page and guidance information, the ICH website and the Acumen Research and Consulting report cited above. Our calculation is labelled. Last updated 30 October 2026. This is news reporting and not advice.