EU ASMF Submission Requirement Updates

From July 1st 2016 all the centralised procedure human ASMF submissions will become mandatory in eCTD.
The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA).
An eCTD baseline should be provided for ASMFs currently in NeeS format.
The mandatory format for ASMF submissions for human medicines is now eCTD or structured NeeS. The use of eCTD will become mandatory for all for centralised procedure human ASMF submissions from 1 July 2016. If an on-going application dossier started in eCTD format, all subsequent submissions should be in eCTD format in order to maintain the lifecycle (once eCTD it is not possible to revert to NeeS). The relevant guidance should be followed & the applicable technical validation criteria has to be passed (eCTD validation criteria and NeeS validation criteria).
So to have an up-to-date solution for eCTD submission becomes a necessity for pharmaceuticals for an easy and quick ASMF submissions in electronic format.
Solution to create ASMF/DMF for electronic submission, should have certain capabilities which would help the clients to file ASMF/DMF in electronic format in a simpler manner
Capabilities like:
  • Module 1 document mapping and granularity management
  • Creating eCTD package with XML backbone and validating the package.
  • Creating Baseline submissions for paper DMFs.
  • DMF life cycle management including the amendments and annual report
  • DMFs that cover multiple items, e.g., container closure systems (Type III) or Flavors (Type IV) in eCTD
  • Electronic Signatures in DMFs
  • Navigation Aid Management including the table of contents and hyperlinks
  • Dossier assembly and compilation in eCTD format
Written by:
Riddhi Doshi
Sr. Consultant – Regulatory Affairs Specialist and Submission Publisher at Sarjen Systems Pvt. Ltd.