The Pharmaceutical Industry's Transition To Electronic ProcessesSource: MasterControl
Any account, however brief, of the pharmaceutical industry’s transition to electronic processes would be incomplete without first mentioning the International Conference on Harmonisation (ICH). The ICH was formed in 1989 to standardize formats for new drug applications in the U.S., Europe, and Japan (at that time, the majority of new medicines were developed by these countries). The ICH not only established the common technical document (CTD) format, but, as early as 1994, began developing the Electronic Standards for the Transfer of Regulatory Information (ESTRI) to meet the requirements of both pharmaceutical companies and regulatory agencies.
This planted the seed for what, a few years later, would blossom into a full-fledged effort on the part of the FDA (and other regulatory agencies) to encourage pharmaceutical companies to abandon their manual, paper-based processes in favor of modern technology. This hoped for transformation held the promise of revolutionizing the development of new drugs. Although many pharmaceutical companies were quick to see the benefits and initiate change, others, for reasons that seem short-sighted, chose to look the other way.