FDA new published documents

FDA new published documents

eCTD and electronic submission in North America

Both in USA and Canada, eCTD and electronic submission will become mandatory on short future.
If you need help with eCTD publishing for FDA or HC, Asphalion has experience and can support you with creating baselines, preparing IND/NDA/ANDA/DMFs and submit through the Gateway.

The Food and Drug Administration released a simple one page document on what you need to know for eCTD requirements and new requirements for DMF.

  • NDAs, ANDAs, BLAs, and master files:  From 5 May 2017 must be submitted using the eCTD standard.
  • INDs: From 5 May 2018 must be submitted using the eCTD standard.
Health Canada
Health Canada announced that from 1st January 2017 the Electronic Submission Gateway will be mandatory format for filing of all regulatory activities.

In addition HC released an advanced notice that it is being considered to have eCTD as mandatory format from 1st January 2018 for mandatory filing of all New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abreviated New Drug Submission (ANDS) , and Supplement to an Abreviated New Drug Submission (SANDS) regulatory activities (for human drugs).
In case you need support for either set-up of the Electronic Submission Gateway or implementation of an eCTD publishing tool, please let us know: info@asphalion.com
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