TGA indications response
July 16, 2012
SPONSORS will be able to use
established sources of evidence to
support indications for established
ingredients, under proposed TGA
amendments to its consultation
document on ‘Evidence required to
support indications for Listed
medicines’.
The TGA has now issued a
summary of the main points of a
variety of submissions from across
the industry, as well as its response.
The consultation document was
launched in April, aiming to clarify
requirements for sponsors and
improve the community’s
understanding of the TGA’s
regulatory processes, and it’s
intended that the final outcome
will replace the current Guidelines
for Levels and Kinds of Evidence to
Support Indications and Claims for
Non-Registerable Medicines,
including Complementary Medicines
and other Listable Medicines.
One of the major issues raised by
the submissions was that “active
ingredients with established
credibility and high levels of
evidence will be significantly
disadvantaged and the amount of
work required to list will be
disproportionate to the risk of the
medicine”.
In response, the TGA says it will
change the document to allow
established sources of evidence to
be used to support indications.
However where these are not
available, a systematic review will
be required to ensure that all
evidence/studies possibly relevant
are identified, and “analysis regarding
statistical and clinical significance is
conducted appropriately”.
Several respondents also argued
that the consultation document
incorrectly accepted scientific and
traditional methods as equivalent,
but the TGA said this was not
intended and will clarify that rather
than indending equivalence, “the
intention is to adopt a transparent
approach where the context of
traditional indications is explicitly
provided to consumers with the
promise of efficacy”.
The TGA said costs involved with
the new arrangements “should not
significantly increase if sponsors’
existing arrangements are
appropriate”.
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