ICH Adopted the M11 Structured Clinical Protocol Standard in November 2025

On 19 November 2025 the Regulatory Members of the ICH Assembly adopted the M11 package at Step 4 of the ICH process. The package has three linked parts: a harmonised guideline, which explains the principles and intended use; a protocol template, which sets out the common structure, headings and content for clinical trial protocols; and a technical specification, which defines how protocol content is represented for electronic exchange.

The name CeSHarP, for Clinical Electronic Structured Harmonised Protocol, describes the aim. Protocols are currently written in many sponsor-specific formats, which makes it hard for regulators, ethics committees, investigators and downstream systems to find the same information in the same place. M11 provides one structure that can be used across sponsors and regions, and a technical specification that allows the content to be exchanged as structured data rather than only as a document.

The ICH M11 Expert Working Group has also issued a final overview presentation to support training and implementation.

In the European Union, an EMA Step 5 document records final adoption of M11 by the Committee for Medicinal Products for Human Use (CHMP) on 11 December 2025. Secondary sources state that the guideline has applied in the EU since 11 June 2026; that date was not confirmed in an EMA document seen for this brief.

In the United States, FDA published a notice of availability in the Federal Register on 22 May 2026 announcing M11 as final guidance for industry (docket FDA-2022-D-3054). The FDA guidance includes all three parts of the ICH package. As FDA guidance, it contains nonbinding recommendations, and secondary sources note that FDA does not require protocols to be submitted in the M11 format.

Some commentary has suggested that FDA and EMA intend to make the M11 format a default for new IND and clinical trial applications from 2028, or that FDA offers procedural advantages for M11 protocols. Those statements were not found in the FDA or Federal Register materials reviewed, and sponsors should not rely on them without official confirmation. The implementation status in Japan and other ICH member regions was not confirmed for this brief.

Taken together, the key dates are as follows: Step 4 adoption by ICH on 19 November 2025; CHMP adoption on 11 December 2025; and publication of FDA’s notice of availability for the final guidance on 22 May 2026. Sponsors operating in both regions can therefore treat the M11 template and technical specification as current regulatory guidance in the EU and the US, while recognising that the regional documents should be checked for any implementation notes specific to each region.

For medical writers, M11 changes the starting point for protocol authoring. Instead of adapting a company template, authors can work to a common internationally agreed structure, with defined sections and content expectations. Sponsors that adopt it will need to map their existing templates and standard text to the M11 structure and train authors and reviewers.

For data and systems teams, the technical specification is the more significant part. Because protocol content can be exchanged in a structured form, information such as objectives, endpoints, populations and schedules can in principle be reused in other systems, such as trial registries, electronic data capture builds and statistical analysis planning, without being re-keyed. Commentators have highlighted this reuse as the main efficiency gain, although the extent of the benefit depends on how sponsors and vendors implement the specification.

M11 is a format and exchange standard. It does not alter what a protocol must contain to meet ICH good clinical practice or regional clinical trial rules, which continue to apply in full.

Sponsors should obtain the three Step 4 documents from ICH and the regional versions from EMA and FDA, compare their current protocol templates with the M11 template, and decide when new protocols will be written in the M11 structure. Early adoption on a small number of new protocols allows teams to test authoring tools and review processes before wider use.

Technology owners should assess whether authoring tools, document management systems and clinical data systems can produce and consume protocol content according to the technical specification. Because use is currently recommended rather than required in the regions reviewed, sponsors have time to plan a phased transition, but should monitor ICH and regional regulators for any change in status.