30 September 2010

The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents.

The documents have undergone a beginning-to-end rewrite to address document format issues, to update information, to improve readability, and to generally streamline the document. In addition, examples in both updated documents reflect changes based on MedDRA Version 13.1.