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International Conference on Harmonisation (ICH) – ICH M11 updated Technical Specification document and Step 2 presentation now available

The ICH M11 (on clinical electronic structured harmonised protocol) updated version of the Technical Specification (TS) document, which incorporates comments received during the first public consultation, has reached Step 2b of the ICH process and now enters the second round of public consultation. The updated template will not open for public comment. The M11 Expert Working Group has also prepared a Step 2 informational presentation which clarifies information on the TS that was included in the initial Step 2 presentation, ensuring alignment with the updated TS. The updated TS Step 2 document, template and presentation are available for download on the M11 page.

News reported on the 2nd of April 2025 in Catapult’s regulatory round-up, read the entire report here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (26 mai 2025). International Conference on Harmonisation (ICH) – ICH M11 updated Technical Specification document and Step 2 presentation now available. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/140go


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