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

Article type: Research Article

Authors: Belkum, Stan van

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: ca.v.belkum@cbg-meb.nl

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.

Journal: Pharmaceuticals, Policy and Law, vol. 4, no. 0, pp. 87-95, 2001