eCTD Mandate to Follow 2-Year Implementation Timeline

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During the opening session of the recent DIA Electronic Submissions Conference in San Diego, Gary Gensinger, Deputy Director, Office of Business Informatics at CDER spoke about the not-too-distant future at the FDA when electronic submissions will become mandatory. Under the draft PDFUA V bill, electronic submissions will be mandated and Gary provided us a timeline for the implementation under the proposed mandate.

In December 2012, the FDA will release draft guidance for this new era, which, among other things, will require electronic submission. The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.

There is another important take-away from this presentation. In the future, the FDA will use this same pattern for implementation of new requirements and guidance. We can expect when the FDA alters its requirements the following timeline will be used:

  • Draft guidance released for public comment
  • Six-month comment period
  • Revision and release of the final version
  • Implementation of the changes 2 years later

With this pattern in place, the process of iterative improvement of FDA standards should be much more consistent going forward. For sponsors, this means greatly improved predictability which allows for greatly improved preparedness

Update: The US FDA will require eCTD format submissions for NDAs, BLAs and ANDAs on May 5, 2017. IND submissions will be mandatory eCTD format on May 5, 2018. 

Author: GuestPost

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