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The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process

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Abstract

The International Conference on Harmonisation’s electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, the goal is the electronic transfer of drug applications and their review across submission formats, procedures, and regions. However, it is still unclear whether implementing eCTD really brings more advantages than disadvantages and, if so, for what kind of companies. After an expert interview was conducted in 2009, this research study was formed as an international survey officially supported by the European Medicines Agency in 2010. Overall, 963 responses were received, and 397 were used for the subsequent study analysis. Although a three-fourths majority of those with eCTD experience reported disadvantages in implementing eCTD, an overwhelming majority of the same group reported advantages that outweighed the disadvantages, some of them significantly. More than three-quarters of individuals with eCTD experience were able to shorten their total time to approval, and more than 90% of this group was able to demonstrate cost savings relative to paper submissions, regardless of their company kind, size, or number of submissions.

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Authors and Affiliations

  1. Department of Human and Economic Sciences, UMIT—The Health & Life Sciences University, Hall/Tyrol, Austria

    Andreas Suchanek

  2. Ascapex GmbH, Jetzendorf, Germany

    Andreas Suchanek

  3. Department of Public Health and Health Technology Assessment, UMIT—The Health & Life Sciences University, Hall/Tyrol, Austria

    Herwig Ostermann Prof., PhD

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  1. Andreas Suchanek
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  2. Herwig Ostermann Prof., PhD
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Correspondence to Andreas Suchanek.

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Suchanek, A., Ostermann, H. The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process. Ther Innov Regul Sci 46, 124–139 (2012). https://doi.org/10.1177/0092861511427871

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