RPS: The Next Phase of eCTD (Regulated Product Submission Standard Increases Flexibility, Capabilities) By Joel Finkle

RPS: The Next Phase of eCTD


Regulated Product Submission standard increases flexibility, capabilities.

By Joel Finkle

June 8, 2011 | Guest Commentary | Today, almost two-thirds of all drug license application and renewal submissions are provided in the approved electronic Common Technical Document (eCTD) format. That figure rises to over 90 percent for electronic submissions to the U.S. Food and Drug Administration (FDA). This makes the job of the FDA much easier, allowing staff to call up and navigate their way through submissions quickly and logically. Applications are put together using meta tags and hyperlinks to attach related content in a way that makes the applications easily searchable.

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.

For More Information Please use the link: BioIT World eCTD