eCTD, eCTD 4, FDA

eCTD 4 — A Love/Hate Relationship

Joel Finkle, Director Regulatory Innovation & IDMP Strategy, ACUTA

Don’t get me wrong: I definitely love eCTD 4 for all the things it’s been designed for. However, we’ve been working on it since 2005, and we’re still years away from its full implementation.  So, I thought I’d make a love and hate list to show what’s good, and what’s going to be trouble.

Love

Hate

  • The eCTD 4 schema is in many ways much simpler: there are fewer elements, because instead of a different XML element for every TOC heading, there’s just contextOfUse.
  • The eCTD 4 schema is built on the very verbose HL7 architecture, which uses a sort of verb/noun structure which is only useful for HL7 data tools that regulators and sponsors are unlikely to use for submissions.

Whose idea was this mess?

  • eCTD software updates will be fewer, and further apart, because the standard is data driven, and won’t need new DTDs (Data Type Definitions) or schemas to add a new document type.
  • The benefits of eCTD 4 will really only be seen once everyone adopts eCTD 4 and stops using eCTD 3.2, which does not have even a hint of a deadline.
  • The common structure also means there’s no need for a separate regional backbone file for module 1.
  • The eCTD 4 backbone isn’t hierarchical, meaning that every TOC entry needs to carry its own metadata, making the backbone file bigger.
  • Documents can be reused more easily because the path to the document isn’t needed: the TOC entries only need to reference the identifier for the document.
  • That same reference system makes the backbone file not particularly human-readable, and validation is somewhat more difficult because there will be references outside of the existing submission sequence.
  • ICH and US FDA have a good handle on the standard, and appear to have a clear route to implementation, including the US pilot in 2018.
  • The European implementation guide is two years old (March 2015) and has some wrong assumptions about the use of some parts of the standard.
  • It should be possible for ACUTA (and other vendors) to amortize their costs of development with the use of the HL7 RPS standard for other industries including Medical Devices, Food Additives, etc.
  • Although IMDRF (sort of the Medical Device equivalent of ICH) worked on the RPS standard, there isn’t much motion toward implementation.
  • There’s still opportunity to influence how it’s used.
  • It’s not here yet.

 

While there’s certainly a lot to love (and I didn’t even mention universal support for grouped submissions, ability to fix misspelled metadata, ability to change granularity and the stake in the heart to the “append” operation), there’s going to be some challenges.  Stay with us at ACUTA, and we’ll show you the path down that thin line between love and hate.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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