10 January 2019

In November 2018, the ICH Assembly met in Charlotte, NC, USA for their bi-annual meeting. To ensure transparency in the ICH process, minutes from this meeting are made publicly available so that all stakeholders can be informed on important decisions and real-time progress of the development of ICH Guidelines.

The minutes of the ICH Assembly meeting provide an overview of the actions and decisions of the ICH Assembly as well as the topics discussed, which include items such as the progress made by each technical working group and their expected timeframes for reaching Step 2b / Step 4 of the ICH process. Furthermore, it also provides a summary of the ICH MedDRA Management Committee’s report to the Assembly.

Further information is provided in the Assembly page.