Affiliations: Agency for the Medicines Evaluation Board in the
Netherlands, The Hague, The Netherlands
Note: [] Agency for the Medicines Evaluation Board, PO Box 16229, 2500 BE
Den Haag, The Netherlands. Tel.: +31 70 3567469; Fax: +31 70 3567515; E-mail:
[email protected]
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.