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Evaluating the Process of the Pattern Change from Paper based to Electronic Submissons of Medicinal Products

Scientifically based analysis of the advantages and disadvantages of the electronic Common Technical Document (eCTD) in Europe and North America

Andreas Suchanek and Dr. Herwig Ostermann

University for Healthcare Sciences, Medical Informatics and Technology (UMIT), Department of Human and Economic Sciences Hall/Tyrol (Austria)

This article is a summary of an empirical social research in form of an e-mail expert interview regarding the change from a paper based to an eCTD based electronic-only submission process in Europe and North America.
Eight international experts were asked about the advantages and disadvantages of eCTD submissions, and they were consolidated in eight different categories each.
Additionally potential reasons for or against an implementation of new eCTD processes were analyzed. The article ends with a short summary and conclusion and a remarkable expert statement regarding the consistency of eCTD for industry and authorities.