An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents come from peer-reviewed scholarly literature.
Obtaining, assembling, transmitting, and managing this volume of materials— before and after any initial submission—is a major task for any pharmaceutical or biotech company. This is true regardless of whether an electronic submission is submitted to a regulatory agency or if traditional paper documents are submitted in those countries where the option still exists. Regulatory affairs professionals who have submission experience know firsthand how time consuming, expensive, and downright exhausting it can be.
In 2008, the FDA mandated that all electronic submissions adhere to the electronic common technical document (eCTD) format. The eCTD standard poses distinct challenges as scientific literature is not typically published in this format but needs to be reformatted to fit the FDA standard.
Even though it has been two years since the electronic system was implemented, many pharmaceutical companies are still struggling to navigate the approval process effectively. Help is available though. Acquiring the necessary published literature for the regulatory approval process can be standardized and facilitated by a CRO, specialized software supplier, or a document-preparation service.
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.