Electronic submission of regulatory information in support of marketing applications for medicinal products. The eCTD: Work in progress

Abstract

The present situation with respect to the use and acceptance of electronic submissions for marketing applications for medicinal products in the United States, Europe and Japan is presented. The activities of the International Conference on Harmonisation (ICH) towards a global standard for electronic submissions are described and the expected impact for the regulatory agencies and the pharmaceutical industry of such a global standard is reviewed.