The history of electronic regulatory submissions technologies

Abstract

The year 2009 marked the 10th Anniversary of electronic regulatory submissions within the pharmaceutical industry. Typically new technologies are introduced to meet business needs of industry and regulatory agencies, which in turn benefits the consumers. However, in many cases implementing new technologies does not necessarily initiate improvements, but has a far greater effect on the processes and people involved. These changes can be beneficial in one area, but pose numerous challenges in others. The purpose of this study is to analyze electronic regulatory submission trends and to gather information on the benefits and challenges to the life sciences industry and regulatory agencies; through the analysis of existing studies and the execution of an independent study. Previous studies concluded that the benefits of eCTD far outweighed its challenges; however, this study reveals that the margin between the benefits and challenges is not as large as purported.