How should a regulator judge a mathematical model that supports a drug dose? That is the territory of the FDA ICH M15 guidance, which sets harmonised general principles for model-informed drug development, or MIDD. The International Council for Harmonisation adopted the guideline in February 2026, and the FDA implemented it as final guidance in June 2026. A stakeholder webinar was scheduled for 29 October 2026 to explain the concepts and take questions. This article explains MIDD in plain terms, describes what the guideline is for and sets out what has and has not been made public about the webinar.
FDA ICH M15 guidance: the essentials
- Scope: general recommendations for planning, evaluating and documenting evidence from model-informed drug development.
- Aim: a harmonised assessment framework with shared terminology across regions.
- Status: adopted by ICH in February 2026; implemented by the FDA in June 2026.
- Webinar: scheduled for 29 October 2026, free and virtual, with a case example and question time.
- Unknown: the content of the live discussion and the timing of pre-recorded presentations.
What model-informed drug development means under the FDA ICH M15 guidance
MIDD refers to using quantitative models to inform decisions during drug development. Pharmacokinetic models describe how a drug is absorbed, distributed and eliminated. Exposure-response models connect drug levels to benefits or side effects. Disease-progression models describe how a condition changes over time with or without treatment, and trial-simulation models test how a study design might perform before it is run. These are general descriptions of the field; the FDA page summarises M15 as covering planning, model evaluation and documentation of evidence.
A hypothetical illustration of the FDA ICH M15 guidance in use
Imagine, purely as a teaching example and not a real case, that a company has trial data in adults and wants to propose a dose for adolescents. A model built on the adult data might predict drug levels in younger patients given their body size and how their bodies handle the drug. A reviewer would then ask whether the question being answered was clearly stated, whether the data support the assumptions, how the model was tested and how uncertain the prediction is. A harmonised framework helps both sides use the same questions and the same words. No part of this example comes from the guideline text or the webinar.
Why harmonisation matters in the FDA ICH M15 guidance
Drug developers submit similar evidence to several regulators. If each region used different terms and expectations for model evidence, companies would have to prepare separate packages. The harmonised framework and shared terminology in M15 are intended to reduce that duplication and to make assessments more predictable. The guideline text is published by the International Council for Harmonisation, and the FDA version is available at fda.gov. Harmonisation does not remove regional differences in how reviews are conducted.
The scientific questions the FDA ICH M15 guidance helps frame
- Is the model suitable for the decision it is meant to support?
- Are the data and assumptions behind it adequate and documented?
- How was the model evaluated, and how were uncertainties handled?
- Is the evidence presented in a way a reviewer can reproduce?
The webinar behind the FDA ICH M15 guidance rollout
According to the FDA’s event page, the webinar ran from 8:30 to 10:00 a.m. Eastern time on 29 October 2026, streamed on YouTube, with no fee or registration. It was to explain the concepts of the final guideline, work through a case example and answer common questions, and the agency also wanted feedback to develop further training materials and case examples. Pre-recorded presentations were listed as coming soon. We have not seen a report of what was discussed, so we cannot say which questions were raised. See the FDA event page and our Pharmaceutical section.
Limits of models highlighted by the FDA ICH M15 guidance context
Models simplify reality. They depend on the quality and representativeness of the data used to build them, and predictions outside the studied range are less certain. Different teams may build different models from the same data and reach different conclusions. Transparent documentation and evaluation, which the guideline addresses, help reviewers judge how far to rely on a model. Model-informed evidence usually supports, and does not replace, clinical trial data. This is general scientific context and not a summary of M15’s detailed text.
Market context from Acumen Research and Consulting
Acumen Research and Consulting’s Computer-Aided Drug Discovery Market report is adjacent to MIDD, not a measure of it. 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. By our own calculation, the endpoints imply about 10.9% a year, so the page is internally inconsistent, and it was last updated in June 2022.
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.
General background: from concept to guidance
ICH guidelines are developed by regulators and industry experts and then implemented by member regions in their own frameworks. The M series addresses multidisciplinary topics.
Our analysis of the FDA ICH M15 guidance
In our assessment, the FDA ICH M15 guidance gives developers a common vocabulary, and the webinar is an outreach step. Its scientific impact will depend on how reviewers and sponsors apply it in practice.
What is not disclosed about the FDA ICH M15 guidance webinar
- Speakers and discussion content.
- The worked case example.
- Training material timelines.
Risks and caveats
This article describes the FDA’s event page and general scientific context and does not summarise the guideline’s full text. It is news reporting and not regulatory advice.
What to watch next
- Pre-recorded presentations.
- New case examples.
- Regulator feedback on submissions.
FAQ
What does MIDD stand for?
Model-informed drug development.
When was the guideline adopted?
By ICH in February 2026.
Can I watch the webinar?
The FDA said it would stream on YouTube and that recorded presentations would follow.
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.
