The eCTD format was designed by the International Conference on Harmonization, it represents a common organization structure for the submission of regulatory information to worldwide health authorities such as the FDA.
An eCTD document is composed of five modules: Administrative Information and Prescribing Information, Common Technical Document Summaries, Quality, Nonclinical Study Reports, and Clinical Study Reports. The reason this format was chosen is because it is optimized for copying/pasting, viewing/printing, annotating, facilitating the export of information to databases, searching within and across applications, and navigating through the document.
As with all electronic submissions, delays can arise when last-minute requests for FDA-quality documents are made. It is no longer acceptable to have documents with anything but clean text. Making sure these documents are acceptable can be a complex process that involves a number of parties. Currently, workflow at many companies is decentralized with multiple insourcing and outsourcing providers.
A pharmaceutical company’s information center might bear responsibility for the task of removing any stray marks, while regulatory affairs professionals might ensure that the documents are formatted, modified, and assembled in a manner consistent with a regulatory agency’s specifications. It involves a great deal of management and juggling before, during, and after any submissions are made.
Companies need a centralized workflow system with standards in place. The eCTD format requires enhanced and specific digital document formatting and the inclusion of key navigation aids, making last-minute requests even more problematic and delaying the drug approval process even further.
When the authorities reading a submittal encounter noncompliant PDF files, they can stop the review until the pharmaceutical or biotech company supplies them with corrected versions—a seemingly finite detail that can cost companies huge sums in lost revenue by impacting time to market and stock prices. As the adage goes, time is money, and this is particularly applicable when it comes to getting a drug through the regulatory approval process and successfully to market.