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A History of eSubmission

The pharmaceutical industry has been aware of the value of eSubmissions for some time. However, as we all know, the regulatory filings in the industry are large, complex and sophisticated. The technology and procedures to meet these challenges have evolved significantly over the years.

We have gone from routinely shipping pallets of paper and experimenting with arcane computer formats, to using established tools to prepare DVDs for the courier pouch, or even just uploading files directly to the authority concerned. This article will review some of these evolutions and highlight the current issues and trends for the filings of tomorrow.

EARLY DAYS: AD HOC APPROACHES

Starting in the 1980s, some of the earliest approaches to eSubmissions were typified by Computer Aided New Drug Applications (CANDAs) in the US and similar initiatives in other regions. A sponsor would provide electronic materials to the reviewer on a sponsor-owned computer. A reviewer working on multiple filings might have many computers on the desk, all using different review systems. While this approach was obviously very cumbersome, it still demonstrated the value of having electronic review materials and systems.

 


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Charles Mathis is a Director of the LORENZ Life Sciences Group. He has worked with LORENZ since 2004 and now heads the Quality Department. Charles participates in standards related activities for LORENZ, working with HL7, FDA, Health Canada and other industry organisations. Charles has been developing electronic regulatory filing systems since 1995, including leading a successful initiative which allowed users to create, submit and access structured SGML/XML documents in a secure environment.
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