What’s in store for the TGA
December 12, 2011
A COMPREHENSIVE package of
reforms is set to sweep across the
Therapeutic Goods Administration
in stages, to enhance the
TGA’s current processes and ensure
that its regulatory framework
remains able to adapt to new
scientific developments and
community expectations.
The reforms are the result of major
reviews across various regulatory
areas including: communications
and stakeholder engagement;
advertising of therapeutic
products; complementary
medicines; medical devices; and
promotion of therapeutic goods.
Under the Blueprint, reforms to
the TGA’s communications and
stakeholder engagement will see
the TGA give priority to actively
engaging with the community and
providing improved information
and education materials over the
next 12 to 18 months, as well as
establishing an Australian
Therapeutic Goods Advisory Council.
Improvements to the advertising
of therapeutic goods will include
the creation of a central point for
all complaints about advertising; as
well as the development of
options for broadening the current
arrangements for pre-approval of
ads to include medical devises and
therapeutic goods on TV; and
developing a more effective
approach to sanctions and
penalties for advertising breaches.
To reduce the level of
non-compliance by complementary
medicines sponsors, the Blueprint
has said the TGA will (in
consultation with stakeholders)
update, and include in the
regulations, the Guidelines for the
levels and kinds of evidence to
support indications and claims.
Other complementary medicines
regulatory changes include the
amendment of the Electronic
Listing Facility to provide increased
guidance and cautionary notes for
sponsors about the potential
consequences of providing
misleading or unsubstantiated
claims, and eliminate sponsors’
access to free text.
In terms of medical devices the
TGA has said it will increase the
rigor of pre-market regulatory
assessment of higher risk medical
devices, and ensure an appropriate
level of evidential review is
undertaken to assure safety, quality
and efficacy of these devices.
Changes will also see
amendments to the way in which a
kind of medical device is included
in the ARTG with the requirement
for sponsors to nominate product
names under each ARTG entry for
each kind of medical device,
improving the ability of the TGA to
facilitate medical device recalls.
Lastly in terms of advertising, the
Blueprint said that Government’s
preference is to maintain an
emphasis on self-regulation and
that the TGA strongly supports
industry’s initiative to harmonise
codes of conduct to incorporate the
industry-led working group’s new
framework of high level principles.
For more details see www.tga.gov.au.
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