Inevitably, eCTD has changed the way individuals and teams work, reducing bottlenecks and increasing accuracy by facilitating collaboration and parallel working, guided by clever software and even more clever business practices. In time, investments in compliant systems and processes will turn out to have been well worth it—especially when once-lengthy timescales for submission processing, reviewing, and approval are reduced.
In the same spirit, then, organizations should not be too alarmed to learn that there’s another new submission standard on the horizon.
The new Regulated Product Submission (RPS) standard—or eCTD version 4—aims to take eCTD to the next level. The goal is to introduce greater flexibility and more-robust capabilities, because the original specification has certain limitations. For example, it is limited to human pharmaceuticals.
This has created inefficiencies for the FDA. Currently, there are different electronic standards for each division, and not every division even has an electronic standard. The situation is expensive for the FDA, which must allocate staff to manage and maintain each of those systems. A single system, covering everything from food additives and medical devices to human therapeutics and veterinary medicines, should simplify things considerably.
There are technical limitations with the existing standard as well. For example, there are differences between Europe and the U.S.—such as the way study data and reports are assembled—despite the standards having been designed to be international in scope. The eCTD also cannot handle all the ways documents are managed across the lifecycle of a product, as amendments get made and old information gets superseded.
The new RPS standard has been in development for some time. The next release is now being honed with input from the International Conference on Harmonisation, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the European Medicines Agency (EMA), and the FDA. It has undergone extensive testing by major user groups—sponsors, agencies, and software vendors—to ensure it will fulfill everyone’s needs. The current goal is to approve Release 2 as a formal standard in late 2013.
The enhancements offered by RPS make it easier to expand eCTD’s capability. This is good news for pharma, because it establishes the ability to handle bundled supplements, to correct attributes, and to cross-reference with previously submitted information (such as Master Files). With RPS, a sponsor with a supplement affecting, say, five applications would need to make only one submission.
One of the primary benefits of RPS is the opportunity for two-way communication, which would enable the regulator to communicate back to the applicant by using the same standard in the applicant’s correspondence, preferably through electronic gateways such as those currently at the FDA and those being developed at the EMA.
For most users, RPS will look much the same as the current version of eCTD. Fears that there will be broad changes in the format or the table of contents or how the submission is structured are unwarranted. While RPS will look different at the back end, it will provide greater flexibility and expandability. When the format undergoes changes, as it inevitably will, the changes will require simple updates to a table of codes rather than a major software change. There will be fewer software cycles, and fewer updates will be required to meet regulatory requirements. As a result, companies will be subject to less demand on time and personnel, leading to reduced costs.
The FDA expects to begin accepting RPS messages in late 2013. As with the original eCTD standard, there will be a transition period, during which the agency will accept both the current version of eCTD and eCTD version 4. Although pharma companies may initially find that their systems have to handle multiple different formats in place at the major regulatory bodies, software solutions are in development to simplify those processes. What’s more, the human processes involved in RPS will be almost identical compared with those for the current eCTD.
Help will be at hand, too, as regulatory information systems and service specialists do all they can to ease the transition, while making sure pharma organizations feel the benefits of new systems and processes sooner rather than later. Ultimately, the benefits of an enhanced eCTD standard will be well worth any additional investment. •
Joel Finkle is senior strategist, Regulatory Informatics At CSC Regulatory Solutions Group. Email: firstname.lastname@example.org