By Ann Neuer
June 22, 2009 | Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions (Learning to Embrace the eCTD, Bio-IT World May/June 2009), the Food and Drug Administration (FDA) is changing the game. FDA is planning to implement an agency-wide standard known as Regulated Product Submission (RPS) that is expected to replace eCTD.
Jason Rock, Chief Technical Officer of GlobalSubmit, an eCTD provider, says, “With the advent of RPS, eCTD will eventually go away. In fact, the next version of eCTD is RPS.”
RPS is a standard put forth by Health Level 7 (HL7), an accredited standards organization, and is being developed in response to performance goals that FDA is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). Currently, the second release of RPS is in development.
This new standard will offer two clear advantages over eCTD. First, RPS will establish two-way communication between the submitter and all FDA-regulated product centers within the agency, such as pharmaceuticals, biologics, medical devices and radiologics, veterinary medicines, and foods. Second, RPS will manage the life cycle of submissions by allowing cross-referencing of previously submitted information. This means that for electronic investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs), information need only be submitted once and previously submitted electronic documents can be applied to marketing applications. As part of this process, archived electronic IND, NDA, and BLA submissions will be retrievable through standardized automated links.
With this expanded agency-wide capability, the scope of eCTD seems limited by comparison as it offers only one-way communication, and is used for submissions to only two centers within the agency—the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). In addition, eCTD lacks cross-referencing capability.
According to Peggy Leizear, program analyst in the Office of the Commissioner, Office of Planning at FDA, RPS will be implemented first at CDER and CBER in late 2011, before being rolled out to the other centers using a yet-to-be-determined schedule. Both centers will implement Release 2 of RPS, which is slated to be “balloted” (voted on) by HL7 as a Draft Standard for Trial Use (DSTU) in January 2010. At that time, testing will officially begin by FDA and by the industry. “Once DSTU happens, we expect to get more engagement from vendors interested in testing the standard,” comments Leizear.
Jason Rock explains that the transition to RPS is not cause for alarm, as the concept behind eCTD and RPS is the same—the use of a standardized format for regulatory submissions, including PDF documents and SAS datasets. “For companies using a software vendor, there should be minimal impact. The impact will be on the vendor. However, if your company built its own program, it will have to be completely re-written as the output is very different. Although document contents are the same for eCTD and RPS, the internal XML (extensible markup language) structures are very different,” Rock says.
When RPS is implemented, FDA will offer a training program for reviewers, which will include hands-on training classes, drop-in clinics where reviewers can receive additional training, and hands-on support. In addition, FDA will provide industry support.
RPS is being developed as an international standard. In addition to the U.S., regulatory agencies from Europe, Canada, and Japan are at varying levels of interest and participation.