The Electronic Common Technical Document (eCTD) is the standard format
for electronic regulatory submissions to FDA (see FDA eCTD).
Since 5th May 2017 eCTD format became mandatory for New
Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics
License Applications (BLAs).
For commercial Investigational New Drug Applications (INDs) and
Drug Master Files (DMFs) the deadline for submitting in eCTD format is
coming up next year, on 5 May 2018.
Remember that eCTD submission (sizes of 10 GB or less) for NDAs, BLAs,
ANDAs and master files must be submitted byFDA Electronic Submissions Gateway (ESG) as of May 5, 2017. Likewise, beginning May 5, 2018 the ESG must
be used for eCTD submission (sizes of 10 GB or less) for commercial INDs.
Submissions that do not fulfill the requirements stated in the eCTD
Guidance will not be filed or received.
Important annual
reporting periods:
–Self-Identification
of Generic Drug Facilities, Sites, and Organizations for fiscal year 2018:
The reporting period is between May 1st and June 1st of 2017.
–Drug
Establishments Current Registration Site: Establishments must renew
registration annually, between October 1st and December 31st of each
year.
Self-Identification and Drug Registration reports must use Extensible Markup
Language (XML) files in the Structured Product Labeling (SPL)format. To transmit the SPL formatted
submission the FDA’s Electronic Submission Gateway (ESG) must be used.
If you want to get the latest information about FDA, please register for
our FDA Open Seminar, 1-2 June in Barcelona: https://www.asphalion.com/openseminar/
Asphalion can help you to be compliant with FDA requirements!
Do not hesitate to contact us: [email protected]
