TGA details cost recovery
July 2, 2012
THE Therapeutic Goods
Administration has released details
of the impact of its ‘Blueprint
Reforms,’ with all TGA fees and
charges for all industry sectors to
increase by 5.6% in 2012/13.
The information is contained in an
‘Addendum to cost recovery impact
statements’ which was posted on
the TGA website on Fri.
The Blueprint Reforms follow a
series of consultations and reviews
over recent years as part of a
commitment to openness and
transparency at the TGA, and
include a wide range of activities
including refined regulatory
processes, improvement of post
marketing processes for OTC
medicines, alignment of business
processes and legislation, providing
more information on the regulatory
framework, online tracking of
applications and much more.
The TGA says that
implementation of the Blueprint
Reforms over the next four years is
expected to cost around $11.7
million - of which $2.3 million will
be incurred this financial year.
“In order to fund these costs, an
increase of 2% across TGA’s fees
and charges will be required in
2012/13” the TGA said, on top of a
further 3.6% inflation-based increase.
The lion’s share of the Blueprint
costs this year relate to
prescription medicines, amounting
to $1.171m of the total, compared
to $150,000 for non-prescription
medicines; $178,000 for
complementary medicines;
$536,000 for devices; $266,000 for
Good Manufacturing Practice;
$42,000 for Blood and just $11,000
for Biologicals.
The document details the total
TGA budget which in 2012/13 is
forecast to amount to $126.7m in
revenue which will be spent on
employee expenses ($84.6m),
Committees ($1.6m), Consultants
($2.1m), Travel ($2.2m), External
Evaluators ($4.96m), Advertising
Regulation ($1.56m), Other
Suppliers ($2.2m) plus a further
$27.2m in Corporate Overheads.
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