If you choose more them one country, prepare separate subsections and/or an overview table like the one below for each ICH region and other countries targeted for registration according to the current project plan; if not, only fill in information on the US. Provide information on the format of planned electronic submissions (e.g., eCTD US or EU format, Asian eCTD, NEES). Provide information on the data exclusivity period gained per region/country