FDA to Postpone Major Electronic Initiatives

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The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.

Submissions in eCTD v3.2.2 format for New Drug Applications (NDA), Biologic License Applications (BLA) and Abbreviated New Drug Applications (ANDA) will not be mandatory until at least Q4 2016, and could very well carry into early 2017. The mandate will then apply to Investigational New Drug Applications in late 2017 or early 2018.

The rollout of the FDA’s new Module 1, considered the biggest change in the history of eCTD, is currently slated for release in June 2014. Using that date as a reference point, the FDA is expecting a delay of 2-3 months according to dialogue GlobalSubmit has had with Agency officials. A more conservative estimate of Q4 2014 was given during a recent webinar presentation to update industry on various eInitiatives.

While formal announcements on the schedule shifts are still forthcoming, Agency officials emphasized the delays would allow for careful planning and further comment by industry.

Postponement of the eCTD mandate is largely due to the FDA’s decision to reissue draft guidance for NDA, BLA and IND submissions in the eCTD format to industry. Final guidance was expected in March 2014, but that release is on hold as the Agency revisits the language. Officials remained “purposely vague” during an online conference Thursday, Dec. 5, but noted that they were conferring with the FDA’s legal department and working toward final approval.

Implementation of the new Module 1, which is currently being tested by the FDA in conjunction with GlobalSubmit, is on hold to ensure that internal migrations being performed by the Agency do not interfere with the transition. Officials indicated that an update with a revised target date would be posted to the FDA’s website in in early or mid-January.

The introduction of a Regulated Product Submissions (RPS) pilot program could now coincide with the mandate of eCTD v3.2.2, but FDA officials stressed that requiring the current version is the primary objective.

Agency representatives noted that eCTD v3.2.2 will be the standard for the foreseeable future and required much sooner than eCTD v4.0.

CDISC data standards were also discussed during the online conference. FDA officials said any type of final guidance or requirements related to this initiative, which is already two decades in the making, were 4-5 years into the future.

The complete slideshow of the FDA’s eCTD update presentation is available at GlobalSubmit’s website.

Author: GS

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