If a semi-trailer truck filled with thousands of documents consistently showed up at your office for review, no one would question your sanity if you tried to put a stop to the practice. The U.S. Food and Drug Administration, the powerful government agency that controls the pharmaceutical industry, has decided to do just that by ending the practice of paper-based regulatory submission, which, in recent times, has generated a continuous tsunami of paper.
To do so, the FDA has mandated the electronic Common Technical Documents (eCTD) specification as the standard format for the submission of all new drug applications and supplements. The agency's decision, which went into effect at the beginning of this year, has increased pressure on life sciences and drug companies to comply by automating and streamlining their operations. U.S. drug manufacturers are scrambling to modify their document publishing and submission processes for compiling new drug submission data — originally designed for paper — so that they can submit product regulatory filings electronically to the FDA.
eCTD submissions simplify the FDA's evaluation process while taking into consideration the creation, review, lifecycle management, and archival of new drug submission data.
"The new electronic standards for the exchange of regulatory filings increases the consistency of the documentation and, hence, the transparency of information," says Hans van Bruggen, president of The Netherlands-based eCTD Consultancy, a firm that advises pharmaceutical and biotech companies on time-to-submission strategies. "Further, using the same exchange standards and structure of information, drug companies can work internally to gradually increase the amount of information and detail in their filings throughout the submission process."