8 February 2017

In November 2016, the ICH Assembly and Management Committee met in Osaka, Japan, for their biannual meeting.

Main decisions taken at the ICH Assembly meeting are reflected in a report including the key progress made at this meeting by each technical working group, including expected timeframes for reaching Step 2b / Step 4 of the ICH process. This report also contains the ICH MedDRA Management Board report to the Assembly on main decisions taken at its meeting in Osaka, Japan, in November 2016.

Main decisions taken at the ICH Management Committee meeting are reflected in a report, and are in relation to its responsibilities for oversight of ICH operational aspects, including administrative and financial matters and oversight of ICH Working Groups.

To ensure transparency in the ICH process, reports from both meetings are made publically available so that all stakeholders can be informed on important decisions and real-time progress of ICH Guideline development.

More details under the Assembly and Management Committee page.