HL7 Standards Enhance Electronic CTD Capabilities

While the current electronic common technical document (eCTD) holds "a ton of value" for FDA-regulated life science companies, leveraging the Health Level Seven (HL7) standards can vastly improve eCTD benefits, said Ken VanLuvanee, president and CEO of Apyx.

HL7 is one of several American National Standards Institutes (ANSIs) -- accredited standards-developing organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards for a particular healthcare domain such as pharmacy, medical devices or imaging. HL7's domain is clinical and administrative data. It is produced by an international community of healthcare subject matter experts, including VanLuvanee, and information scientists who collaborate to create standards for the exchange, management and integration of electronic healthcare information.

But to better understand how HL7 can enhance eCTDs, it is important to understand the current eCTD model, VanLuvanee said. He listed some weaknesses of the current version:

It is focused on "snapshots" rather than on submissions or applications; It provides limited or no support for common paper-submission practices; It can't include documents submitted to other applications by references or hyperlinks; and It leaves open some areas where documents must be resubmitted upon marketing application, rather than being included by reference.

Even so, the HL7 model will "make fuller use of the advantage provided by XML for management of submissions" on multiple levels by identifying "containers" that can be referenced. It also enables the easy navigation of esubmissions with the referencing ability of paper submissions. It works by using XML to uniquely identify and relate submission components in a hierarchy. That allows for more information to be compiled about a component and its section in the submission, as well as the submission overall, he said. But new tools will be needed to allow submission readers to capture and interpret this additional data, VanLuvanee noted.

HL7 will also provide built-in version controls to support document granularity -- the ability to change one cell rather than the whole document -- and change management, he said. In addition, documents can be identified and referenced by a unique ID that would clarify both the document (or component) and its correct version.

Using HL7, eCTD sections will also be identified uniquely so they can be referenced from anywhere. This means that additional documents or components supplied to the investigational new drug application during drug product development won't need to be resubmitted for approval, VanLuvanee said.

For more information on HL7 and XML-related tools, contact VanLuvanee at ken.vanluvanee@apyx.com (mailto:ken.vanluvanee@apyx.com). -- Michael Causey