FDA Requires Pharma Firms to File Electronically

Feb. 13, 2017

The countdown begins starting May 5, pharmaceutical, biologic and generic manufacturers will have to submit to the U.S. FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) all New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) using the electronic Common Technical Document (eCTD).

Drug Master Files (DMFs), Biological Product Files (BPFs) and other master files also have to meet the May 5th deadline for transitioning to the eCTD. The only exemptions that will be allowed will be for single patient compassionate use investigational new drug applications (INDs) and academic-initiated INDs, according to Regulatory Affairs Professionals Society.

The eCTD is designed to make regulatory submissions easier and more efficient by requiring a common global standard for companies to electronically submit the quality, safety and efficacy information required for approval to the regulatory agencies in the United States, EU, Canada and Japan, says RAPS.

Internationally, the eCTD has been required for Centralized Procedure applications to the European Medicines Agency (EMA) since 2010.

Read the RAPS story