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Full Implementation Of The Common Technical Document (CTD) Format #11191

November 20, 2019,

The Director General (NAFDAC) has approved June 1st, 2020 for full implementation of the Common Technical Document (CTD) format requirement for submission of product dossiers in support of Marketing Authorization (MA) applications in line with the Agency’s transition policy to CTD dossier submissions.

This is an extension of 28 months from the previous deadline of February 18, 2018

Stakeholders should note the following:-

  1. On-going applications for new registration and applications for renewal of marketing authorization at different stages of processing for registration submitted before November 18, 2019 will be processed.
  2. Considering the review time for the applications already going through the registration and renewal process, all new applications from November 18, 2019 (yet to be uploaded) are expected to meet requirements for CTD; dossiers found acceptable before applications for Marketing Authorization can be progressed.

NAFDAC MANAGEMENT