Electronic Submission for Changes to OTC Monographs?

6th September 2017

The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review process and finalise pending monographs as quickly as possible. To that end, they are seeking passage by Congress of The OTC Monograph User Fee Programme (OMUFA).

Similar to The Prescription Drug User Fee Act (PDUFA), the programme would require fees from industry for FDA reviews. In the case of ITC monograph order requests (OMOR), the FDA has declared that "all monograph submissions from industry are to be electronic rather than paper.

"Industry may submit monograph electronic submissions to FDA starting on 1 October, 2017."

Below are additional statements relating to submissions:

  • "If the submission is not electronic, each item in the reference list and all in-text references should provide specific location data for the full copy of the referenced material."
  • "The FDA encourages electronic submissions… FDA recommends that the generally recognised as safe and effective (GRASE) data submission be organised using the general structure and table of contents (TOC) described in the common technical document (CTD) in effect at the time of the submission."
  • "Whether the submission is electronic or paper, it should include navigation aids. If the submission is electronic, the TOC should include hyperlinks to each section. An electronic document that references another document in the submission should contain hyperlinks to the cross-referenced document or relevant part of the document. If a submission is not electronic, the submission should also be organised using the electronic CTD (eCTD) TOC."

The FDA plans to issue additional draft guidance addressing electronic submissions by 1 October, 2019 and a final guidance for electronic submissions for the monograph by 1 April, 2021. In the meantime, the recommendation is to utilise the instructions provided in the previously noted sunscreen guidance.

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