The Challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry
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0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
THE CHALLENGE OF GLOBAL ELECTRONIC SUBMISSION STANDARDS IN THE BIOPHARMACEUTICAL INDUSTRY RONALDD. FITZMARTIN, PHD, MBA Executive Director, Biostatistics and Clinical Data Management, Purdue Pharma L.P., Norwalk, Connecticut
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., PDE or ASCII) may be more appropriate than another. The International Conference on Hamnization, working with the standards initiatives, should be the mechanism for effecting convergence3 hamnization, and maintenance of the global electronic submission standards.
Key Words: Electronic standards; Electronic submissions; Electronic NDA; ICH; CANDA
INTRODUCTION
shorter and shorter due to the increased complexity and costs associated with clinical triPHARMACEUTICAL COMPANIES, as als, shortened patent exclusivity, rapid availwell as many other multinational corpora- ability of generic competition, and managed tions, have realized that product development healthcare demands for cheaper products. and marketing must be on a global scale. In One way to increase the life cycle of a prodthe current competitive environment, the life uct is to expand the available market beyond cycles of drugs and biologics are getting the United States. Commercial success today depends on the development of new products and bringing them to global markets much more quickly than ever before (1). Reprint address: Ronald D. Fitzmartin, PhD. MBA, meever-increasing time and to bring Executive Director, Biostatistics and Clinical Data new drug products through the clinical proManagement, Purdue Pharma L.P., 100 Connecticut cess provides a powerful incentive to pursue A ~ Norwalk, ~ ~06850,~ email:~rfi&m&n@pha, a program of simultaneous multinational dema.com 745 Downloaded from dij.sagepub.com at University of New England on June 1, 2015
Ronald D. F i t m r t i n
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velopment. The obvious benefit is that data collected in one country can be used t
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