TGA CM reforms rolling on
March 21, 2012
THE Therapeutic Goods
Association is examining the
sanctions and penalties associated
with repeated breaches of its
regulations, with Parliamentary
Secretary for Health and Ageing,
Catherine King, telling a
Complementary Medicines Industry
Leaders’ reception at Parliament
House last night the move will
“provide extra incentive to those
sponsors who have not quite been
at the level we require”.
King outlined the current major
reform process for the TGA, which
will aim to increase compliance
with regulatory requirements.
She said the TGA was also looking
at amending labelling of
complementary medicine products,
including clear explanation of the
‘AUST L’ number on these items.
“It is the Government’s view that
greater explanation of the
regulatory arrangements for
complementary medicines,
including this labelling change, will
enhance public faith in the
regulator and be a positive step
towards greater transparency,” King
told the reception.
A key part of the reforms will be
close collaboration with the
industry, and King confirmed that
she had asked the TGA to establish
the Therapeutic Goods Advisory
Council which will oversee the
implementation and evaluation of
recommendations resulting from
the transparency review.
King said that the government
“realises the importance of the
complementary medicines industry
to Australians, to our economy, and
to the growing numbers of
Australians who choose
complementary medicines for their
health and wellbeing”.
Regulatory and cost recovery
impact assesssment as well as
amendments to the regulations will
be required in some cases.
“Increased compliance will reduce
the criticism levelled at your
industry and improve trust,” she said.
The above article was sent to subscribers in Pharmacy Daily's issue from 21 Mar 12To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 21 Mar 12
