Action required: The FDA withdraws support for eCTD Module 1 US Regional DTD 2.01.

FDA’s eCTD end of life? Not quite, but it looks like we are getting there. In October last year, the FDA announced the end of support for eCTD Module 1 US Regional DTD 2.01 for marketing applications. By 1st March 2022, the FDA requires all submissions to be compliant with eCTD Module 1 US regional DTD 3.3. Although the new format has been around for some time, the deadline is in less than a year from now!

But that seems just to be the beginning of the move to more structured automated data driven assessment. The FDA is doing more and has launched new initiatives such as KASA (Knowledge-aided Assessment and Structured Application) for a more data driven approach to Marketing Application (MA) assessment. In particular, the KASA system has been designed to

  1. Capture and manage knowledge during product life cycle.
  2. Establish rules and algorithms for risk assessment, control and communication.
  3. Perform computer aided analysis of applications to compare regulatory standards and quality risks across applications and facilities.
  4. Provide a structured assessment that minimises text-based narratives and summarises provided information.

KASA will modernise the process of MA assessment via the use of structured data. We will come back to KASA in more detail in a future blog.

So what about eCTD 4.0?

But what about some kind of middle ground between eCTD 3.2.2 and KASA? What about eCTD 4.0? Any mileage in that? Although no firm dates have been set yet for eCTD 4.0 to become mandatory, checking on the ICH website the following timelines are revealed:

Source: ICH

With most agencies planning to go into pilot during 2022, not much time is left for Marketing Authorisation Holders (MAHs) to get ready. So what is eCTD 4.0 all about?

Advantages of eCTD 4.0

eCTD 3.2.2 has served the industry and regulators well over the years, but it is showing its limitations with the limited ability of changing meta data assigned to eCTD nodes being one of them. Another limiting factor is document granularity that, without major effort, is fixed for the entire life cycle of a document. Both of these have been addressed in eCTD 4.0.

There are other advantages of moving to eCTD 4.0:

  1. All content from Module 1 to 5 is contained in one exchange message, harmonising the submission units.
  2. Documents can be referenced via unique IDs from the same or different submission units.
  3. Allows reuse and life cycle of meta data.
  4. Ability to apply changes to keywords that further define the submission content.
  5. Introduction of controlled vocabularies, a method the IDMP SPOR project is already benefiting from.

The move from eCTD 3.2.2 to eCTD 4.0 comes at a price though, as without a Transition Mapping Message (TMM) sponsors will not be able to move to eCTD 4.0. The TMM requirement is for all submission content in ‘current view’, which is to be referenced in the new format. Just a few weeks back in January 2021 the FDA released the eCTD v4 Technical Conformance Guide version 1.1, containing updates mainly made following comments during the comment period. One major change is the removal of two-way communication. I will come back to the eCTD 4.0 itself in a future blog.

In summary

So is this indeed the end of life of eCTD? Probably not yet. At least for now, regulators in Europe, North America, Australia and elsewhere require MAHs to submit MA in eCTD 3.2.2 format with eCTD 4.0 approaching fast. Additional meta data together with further flexibility on document granularity and attribute life cycle will ease the assessment process somewhat, but a more structured data driven approach such as KASA is desirable.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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