FDA move to only accept eSubmissions

FDA LogoWith the progress of technology we are bit by bit transitioning to working paperlessly in a range of different industries. In the pharmaceutical industry, this has been evident since 2003 when the US Food and Drug Administration (FDA) started accepting submissions using electronic common technical document (eCTD) specifications. So far the transition to eSubmissions to the FDA has been optional. However, most pharmaceutical companies have already adopted the use of eSubmissions.

By May 2017, the submission of eCTD will be mandatory for New Drug Applications, Abbreviated New Drug Applications and Biologics Licence Applications. In May 2018, Commercial Investigational New Drug applications are also to become compulsory, with a start in May 2018.

By having manufacturers submitting their applications electronically, the workload of the FDA is eased. Submissions by paper are not only daunting in physical size with page numbers sometimes ranging in the tens of thousands, but the searchability of those papers is also virtually nil – leaving the reviewer to riffle through the pages to find a referenced document.

Here at Debenu we are paying close attention to the changes in the eCTD requirements, constantly working to improve Debenu PDF Aerialist Pharma so that it meets the demands for preparing documents for eSubmissions.

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