Is your organization planning for the transition to electronic submissions using the eCTD specification? In September 2006,
the FDA announced the withdrawal of the guidance for electronic submission of the following three submission types:
- Providing Submissions in Electronic Format—NDAs (eNDAs)
- Providing Regulatory Submissions in Electronic Format—ANDAs (eANDAs)
- Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs (2003)1
Currently, applicants have three choices when submitting a marketing application electronically: Use the eNDA/eANDA format,
use the eCTD format, or use what is called a hybrid submission (the older eNDA format with the table of contents organized
using the newer CTD headings).2
The variety of choices can be confusing and frustrating for the life sciences industry, which is not receiving consistent
recommendations about how to electronically submit marketing applications. It is also confusing and frustrating for the agency
review staff and has forced the agency to maintain expensive, duplicative processes and systems for receiving and archiving
these various application types.2
(PHOTOGRAPHY: COMSTOCK ILLUSTRATION: JENNIFER FOLEY )
|
With the recent guidance withdrawal, FDA has simplified the guidance maze by exclusively condoning the use of the guidance:
Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using
the eCTD Specifications. So, now the eCTD specification has taken center stage at both the FDA and within the industry.
eCTD Capabilities
The eCTD guidance sets itself apart technically from the eNDA and eANDA guidance in that the submission's table of contents
is no longer submitted as a PDF file. With the new eCTD standard, the FDA and the international life sciences standards entity,
the ICH (International Conference on Harmonization), introduce a major change to the fundamental structure of the submission
by using an XML file as the underlying backbone, which in turn defines and contains the table of contents.
Breakdown of the Five Modules
|
The basic architecture that the eCTD standardizes is a five-module approach adapted from the Common Technical Document (CTD)
originally developed by the ICH. This five-module architecture is used to organize the vast amount of information that is
included within a submission.
Within the sections, the eCTD specification also limits the file formats an applicant can use within an electronic submission.
Among those supported are PDF files for reports and forms; SAS XPORT (version 5) transport files for datasets; ASCII text
files for SAS program files and NONMEM control files; MS Word (RTF) for draft labeling; as well as growing support for the
CDISC SDTM data standard.
XML benefits
Capitalizing on the acceptance and adoption of XML technology, the eCTD specification allows reviewers and submitters to easily
browse submissions using a common Internet browser. Leveraging the power of the XML standard as it is applied to the eCTD
specification, dossiers can be viewed comprehensively with each amendment layered against the original submission, rendering
the life cycle and documentation of a product as it changes over time in an easily viewable and understandable format.
Specifically, using the XML file allows an applicant to update the application's table of contents automatically as new amendments
are filed. This enables sponsors and reviewers access to a real-time, up-to-date, cumulative table of contents and immediate
access to all files included in an application, regardless of when they were included or in what submission they are located.
This type of flexibility and efficiency has never been previously possible at either the applicant or reviewer levels. Applying
the eCTD specification to the XML standard also provides for reusability of the applicant's submission documents for different
regional markets.
