5/6 June 2024
The European Medicines Agency (EMA) published the ICH M11 (CeSHarP) draft Guideline for comments in October last year. ICH's new M11 Guideline is intended to provide a comprehensive clinical protocol organization with standardized content. The Guideline consists of the following three individual documents:
Following the end of comment period in February 2023, the EMA has now updated the website to include overviews of comments received on these three documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template (more than 100 pages).
More information is provided under ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline published on the EMA website.