Update on the ICH M11 CeSHArP Technical Specification

Extractables & Leachables - Live Online Training

Recommendation

6/7 May 2025

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging / Devices & Single Use Systems

The ICH M11 Expert Working Group (EWG) has completed the M11 Technical Specification (TS), incorporating the refinements needed to ensure its alignment with the updated template. The updated version of the template reflects public feedback from the 2022 consultation and additional input from the EWG’s ongoing work. However, a second public consultation on the TS is being conducted to provide the public with an opportunity to review and comment on the updated version. The comment period ends on 22 April 2025.

Role of the M11 Protocol Template

To facilitate the review and public comment of the completed TS, the updated template is being provided as a reference document. It is important to emphasise that the purpose of this consultation is to seek public comment on the TS only. The template is included solely to aid in the review and understanding of the TS and is not open for public comment during this consultation, as it has been thoroughly reviewed during the 2022 public consultation period.

The purpose of the new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent manner and provided in a harmonised data exchange format acceptable to the regulatory authorities. The ICH M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) Template provides comprehensive organization of clinical protocols with standardised content, including both mandatory and optional components. The Technical Specification (TS), acceptable to all regulatory authorities in the ICH regions, presents the conformance, cardinality and other technical attributes that enable interoperable electronic exchange of protocol content, with the goal of developing an open, non-proprietary standard to enable electronic exchange of clinical protocol information.

More information is available on The EMA Website ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline.