The Challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry

Abstract

The international drug development environment is characterized by tremendous pressure to reduce health care costs, increasing government regulations, longer product development time, and shorter marketing exclusivity. Throughout the 1980s and 1990s many pharmaceutical companies and regulatory agencies have shown a commitment to the exploration and implementation of new technologies and to the establishment of open systems for the electronic exchange and review of regulatory information. The major electronic standards initiatives, Drug Application Methodology with Optical Storage (DAMOS), Multi Agency Electronic Regulatory Submission (MERS), Market Authorization by Network Submission and Evaluation (MANSEV), Electronic Submission for Market Authorization (SEDAMM), and the ICH Multidisciplinary Group (ICH-M2) on Electronic Standards for the Transfer of Regulatory Information, have very similar goals. There are very few differences among the standards initiatives at the highest level of the submission structure, and it is only at the detailed document or data structure level that a particular technology (eg, SGML, PDF, or ASCII) may be more appropriate than another. The International Conference on Harmonization, working with the standards initiatives, should be the mechanism for effecting convergence, harmonization, and maintenance of the global electronic submission standards.

Keywords

Electronic standards Electronic submissions Electronic NDA ICH CANDA

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