8 April 2016

In April 2016, further to the update of the Regulatory Notice Document (RND) in January 2016, the S1 Expert Working Group has completed a Prospective Evaluation Period Status Report. This Status Report which provides a brief overview of the study‚Äôs progress and actions taken by the EWG to ensure successful completion of the study is now made available on the ICH website.

For more details, see the S1 Status Report on the Safety Guideline page.