Electronic Submissions—A Guide for Electronic Regulatory Submissions to FDA

Since the last edition of this book, there have been numerous new developments

in the electronic submissions (e-submissions) arena across the world, specifically

in the International Conference on Harmonization (ICH) regions (United States,

European Union, Japan, and Canada). Several initiatives, some independent and

some directly related to e-submissions, have been either implemented or are at

the point of being finalized for implementation.