As recently as the 1940s, submissions to support the marketing of medicines were small single-volume dossiers containing fewer than 100 pages of data, most of which was manufacturing information.
An interesting article written by Tim Felgate explores how these simple paper submissions evolved into today's electronic Common Technical Document (eCTD). The article explores the factors that have brought the eCTD to where it is today, as well as examining the issues that the pharmaceutical industry face. It concludes by highlighting some of the future developments that will impact the business.
Categories: pharmaceuticals, regulatory, XML
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