New TGA OTC consultation
November 29, 2013
The Therapeutic Goods
Administration is inviting
comments from interested
parties on draft OTC medicine
monographs, covering topical
imidazole antifungals, topical nasal
decongestants and pholcodine.
The documents are part of the
new N2 application route for
registration of OTC medicines
which aims to enable faster, more
efficient approval to market for
well-established lower risk OTC
medicines which are compliant
with an applicable monograph.
A 12 month trial of the N2
application route was launched
on 01 Oct 2013, with the process
involving shorter evaluation times
because of less requirements for
data assessment by the TGA.
The new monographs add to
the three previously published,
covering aspirin, paracetamol and
ibuprofen, with the documents all
developed in collaboration with NZ
regulator Medsafe.
Consultation responses are
sought by Fri 10 Jan 2014, with the
items now online at tga.gov.au.
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