Action on indications urged
June 27, 2014
The Australian Self-Medication
Industry says it’s disappointed that
legislative reform of Permitted
(coded) indications for Listed
Medicines has stalled (PD Wed),
after the Therapeutic Goods
Administration confirmed it would
not be progressing the required
legislation at this stage.
The TGA had proposed removing
the “free text” option for sponsors
listing a medicine on the Australian
Register of Therapeutic Goods,
which it said had resulted in a
large number of inappropriate
indications and other statements
being entered on the ARTG.
Earlier this week the TGA
published submissions to a
consultation on the proposals,
with the Office of Complementary
Medicines (OCM) announcing that
implementation would be delayed
pending broader consideration of
the implications of the deregulation
agenda for the TGA.
ASMI Regulatory and Scientific
Affairs Director, Steve Scarff, said
the organisation and its members
had put a substantial amount of
work into the reform.
“We urge the TGA to press
ahead,” he said.
Scarff said the OCM had noted
that part of the Permitted
Indications reform can be
implemented within the existing
regulatory framework or increased
regulation.
In particular, the updating of the
indications list in the Electronic
Listing Facility will be progressed,
which will make it easier for
sponsors to select indications
which are both eligible for listing
and compliant with advertising
requirements.
Scarff said that ASMI was
reviewing the draft Permitted
Indications list, including for
traditional medicine indications,
and would work with members
and the TGA “to ensure a
comprehensive list is developed.”
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