The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electro
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The Electronic Common Technical Document (eCTD): An International Pro/Con Analysis of the Pharmaceutical Product Electronic Submission Process
Drug Information Journal 46(1) 124-139 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511427871 http://dij.sagepub.com
Andreas Suchanek1,2 and Herwig Ostermann, Prof., PhD3
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. Keywords electronic Common Technical Document (eCTD)/(CTD), drug regulatory affairs, drug registration process, eCTD advantages and disadvantages
Introduction For several decades, paper-based submissions have been the method of choice for the drug registration process in the pharmaceutical industry. However, changing information technology trends, the extensiveness of data, consistently decreasing reviewing times, and nearly nonexistent paper archiving capacities at regulatory authorities’ facilities make electroniconly submissions necessary.1,2 The electronic Common Technical Document (eCTD)3 has been defined by the European Medicines Agency (EMA) in this manner: ‘‘an eCTD is the submission of (mostly) PDF leaf documents, stored in the eCTD directory structure, crucially accessed through the XML backbone (index.xml) and with the files’ integrity guaranteed by the MD5 Checksum.’’4 It is more succinctly described as the defined electronic transfer format of the paper-based CTD, and it strives to become the most important pharmaceutical electronic submission format. Nonetheless, after 8 years of being defined through the International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH),3,5 discussions of its use generate more questions than answers in the industry. ‘‘However, there are immense value and benefits of ICH to regulators as well. The CTD and the eCTD have
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