Complementary reform
March 16, 2012
THE listing of evaluated registered
complementary medicines (CMs)
on the TGA website is just the “first
step” in a much-needed reform of
the sector, according to the
Australian Self-Medication Industry.
Speaking in the wake of the public
release of the list of AUST R
(Registered) CMs (PD yesterday),
Executive Director of ASMI, Dr
Deon Schoombie, said that other
measures are now needed to sureup
public confidence in the use of
evidence-based CMs.
“It is pleasing that we have
greater transparency, and that
consumers are now aware of
products which have been fully
evaluated for quality, safety and
efficacy,” Schoombie said.
“However, reform is also needed
to address the lack of data
protection on the evidence
required to support applications for
registration,” Schoombie added.
ASMI also called for the
implementation of data protection
measures which would encourage
research that will in turn help to
generate more evidence necessary
to build confidence and rigour in
the CM sector.
The implementation of the
remaining industry reforms from
the Expert Committee on
Complementary Medicines in the
Health System, including increased
post-market surveillance, together
with penalties and sanctions as
deterrents against non-compliance,
is also a priority, ASMI said.
“Unfortunately, the publication of
this list by the TGA does nothing to
shift us to where we need to be
with respect to strengthening the
regulatory framework for “listed”
CMs, given that the vast majority of
CMs are listed products,” said
Schoombie.
“This system requires genuine
reform, where consumers have
adequate information about
evidence and health claims for
medicines, and where the degree
of regulation is commensurate with
the risk posed by the medicines,”
Schoombie added.
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