• By ICR Secretariat
  • Posted Monday, June 19, 2017

ICH Expands MedDRA's Uptake Globally

http://raps.org/Regulatory-Focus/News/2017/06/12/27888/ICH-Expands-MedDRAs-Uptake-Globally/

This week The International Council for Harmonization (ICH) touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA). MedDRA, which was initially developed to provide standardized medical terminology for regulatory purposes, is available to regulators at no cost and to drugmakers on a sliding scale based on the company's annual revenue.

ICH also said its M1 Points to Consider (PtC) Working Group has developed "condensed versions" of its documents that will be translated into nine MedDRA languages other than English and Japanese, as full versions of the document are already available in those languages. According to ICH, these condensed translations will be available later this year.