Notice2026-10295
M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
Primary source
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Published
May 22, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)" issued on December 22, 2022 (87 FR 78696), and "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol" issued on June 6, 2025 (90 FR 24146).
Full Text
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<title>Federal Register, Volume 91 Issue 99 (Friday, May 22, 2026)</title>
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[Federal Register Volume 91, Number 99 (Friday, May 22, 2026)]
[Notices]
[Pages 30310-30312]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-3054]
M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP);
International Council for Harmonisation; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``M11
Clinical Electronic Structured Harmonised Protocol (CeSHarP).'' The
guidance was prepared under the auspices of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH). The guidance includes three documents: a guidance, a
template, and a technical specification document. The guidance provides
the rationale and recommendations for implementing a harmonized digital
clinical trial protocol. The template features standardized content
structure and formatting, including headers and common text elements.
The technical specification document contains harmonized terminologies
and standardized data fields to enable electronic exchange of clinical
protocol information. The intent of the guidance is to create an
internationally harmonized standard for the content and exchange of
clinical trial protocol information, facilitating the review and
assessment by regulators, sponsors, ethical oversight bodies,
investigators, and other stakeholders. This guidance finalizes the
draft guidances ``M11 Clinical Electronic Structured Harmonised
Protocol (CeSHarP)'' issued on December 22, 2022 (87 FR 78696), and
``M11 Technical Specification: Clinical Electronic Structured
Harmonised Protocol'' issued on June 6, 2025 (90 FR 24146).
DATES: The announcement of the guidance is published in the Federal
Register on May 22, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the
[[Page 30311]]
instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-D-3054 for ``M11 Clinical Electronic Structured Harmonised
Protocol (CeSHarP).'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Y. Veronica Pei, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6462, Silver Spring, MD 20993-0002, 240-402-7091,
<a href="/cdn-cgi/l/email-protection#154c747b724370677a7b7c76743b45707c557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="2b724a454c7d4e59444542484a057b4e426b4d4f4a05434358054c445d">[email protected]</span></a>; or Phillip Kurs, Center for Biologics
Evaluation and Research, Food and Drug Administration, 240-402-7911.
Regarding the ICH: Brooke Dal Santo, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6304, Silver Spring, MD 20993-0002, 301-348-1967,
<a href="/cdn-cgi/l/email-protection#abe9d9c4c4c0ce85efcac7f8cac5dfc4ebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="e6a49489898d83c8a2878ab587889289a6808287c88e8e95c8818990">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``M11 Clinical Electronic Structured Harmonised Protocol
(CeSHarP).'' The guidance was prepared under the auspices of ICH. ICH
seeks to achieve greater regulatory harmonization worldwide to ensure
that safe, effective, high-quality medicines are developed, registered,
and maintained in the most resource-efficient manner.
By harmonizing the regulatory requirements in regions around the
world, ICH guidelines enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
The six Founding Members of the ICH are the FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to <a href="https://www.ich.org/">https://www.ich.org/</a>).
ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and consensus-driven process that results in
the development of ICH guidelines. The regulators around the world are
committed to consistently adopting these consensus-based guidelines,
realizing the benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
In the Federal Register of December 22, 2022 (87 FR 78696), FDA
published a notice announcing the availability of a draft guidance
entitled ``M11 Clinical Electronic Structured Harmonised
[[Page 30312]]
Protocol (CeSHarP).'' The notice gave interested persons an opportunity
to submit comments by February 21, 2023.
In the Federal Register of June 6, 2025 (90 FR 24146), FDA
published a notice announcing the availability of a revised draft
guidance entitled ``M11 Technical Specification: Clinical Electronic
Structured Harmonised Protocol.'' The notice gave interested persons an
opportunity to submit comments by July 7, 2025.
After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in November 2025.
This guidance finalizes the draft guidances issued on December 22,
2022, and June 6, 2025. The guidance provides harmonized and
comprehensive technical recommendations for clinical trial protocol
through three key documents: the guidance, which provides the rationale
and recommendations for implementing a harmonized digital clinical
trial protocol; a standardized protocol template featuring standardized
content structure and formatting, including headers and common text
elements; and a technical specification document containing harmonized
terminologies and standardized data fields to enable electronic
exchange of clinical protocol information. Revisions were made to all
documents addressing public comments and providing greater clarity to
key terms and scope.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``M11 Clinical Electronic Structured
Harmonised Protocol (CeSHarP).'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 pertaining to clinical trial design and protocols
have been approved under OMB control number 0910-0014.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10295 Filed 5-21-26; 8:45 am]
BILLING CODE 4164-01-P
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