Complementary matters
March 15, 2012
THE Therapeutic Goods
Administration’s decision to publish
a list of evaluated Registered
complementary medicines on its
website, has been welcomed by the
Complementary Healthcare Council
(CHC) of Australia, who said it is a
further positive step towards a
more transparent regulatory process.
“We’re pleased to see the TGA
working towards their goal of
becoming more transparent,” said
CHC Executive Director, Dr Wendy
Morrow.
“Customers are at the heart of
the complementary medicines
industry so the more information
that is made available to them
about the products the better,
whilst at the same time respecting
‘commercial in confidence’
matters,” Morrow added.
The list of Registered
complementary medicines is now
available on the TGA website, and
includes the name of the product
sponsor, the date the product was
listed on the ARTG, and a link to
additional background information
on registered medicines.
Despite its welcome of the move,
the CHC did ask that the TGA add
some information to the list which
highlights the difference between
Registered (Aust R) and Listed (Aust
L) products.
“It is crucial to note the
differences between Aust R and
Aust L products,” the CHC said.
“Listed products are evaluated for
quality and safety but are not
required to be Registered as they
are not considered to be ‘high risk’
products,” the CHC added.
The CHC went on further to
illustrate its point, saying that
because of their “higher risk” status
Registered therapies are assessed
for safety, quality and efficacy;
whereas Listed medicines are
“consumer choice” products
designed for minor ailments whose
ingredients are approved by the
TGA for safety and quality.
Morrow also used the
opportunity to reiterate the CHC’s
Pre-Budget Submission calls for a
clinical trials partnership to foster
further scientific research and add
to the existing evidence base.
“We are committed to an
appropriately regulated industry
underscored by science and one
that works with consumers to
ensure they have access to both
high quality information and
products,” she added.
MEANWHILE, self-appointed
industry watchdog, Dr Ken Harvey,
has taken umbrage to the CHC
saying Registered medicines are
assessed for safety, quality and
efficacy, arguing that “the sponsors
primarily submitted them for
registration because they had
clinical evidence to support higher
level claims”.
“Indeed, of the 25 products on
the TGA’s list of Registered
complementary medicines most
are unremarkable: iron, calcium
&/or Vitamin D, Calcium ascorbate
complex, Psyllium fibre, Ispaghula
husk and MUTAFLOR for
constipation , Eucalyptus Oil 11%
w/w and Lemon Tea Tree Oil 1.0%
for head lice and clove oil for
toothache,” he added.
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