Evidence consultation
April 23, 2012
THE TGA has entered into a
consultation over new guidelines
governing evidence for low risk drugs.
The consultation will look at a
document entitled ‘Evidence
Required to Support Indications for
Listed Medicines (excluding
sunscreens and disinfectants)’, and
is expected to take around five
weeks to complete.
The document is intended to
replace the ‘Guidelines for Levels
and Kinds of Evidence to Support
Indications and Claims for Non-
Registerable Medicines, including
Complementary Medicines and
other Listable Medicines’, and
specifies the type of evidence
required to support indications for
listed (low risk) medicines.
Amongst the guides outlined in
the document is the requirement
for the separation of
scientific and traditional-use
evidence; as well as guidance for
sponsors about how to identify
potential sources of evidence and
how to assess evidence in terms of
its relevance, quality, outcomes and
consistency, in relation to a
proposed indication.
The document also calls for
specific information (incl examples)
relating to weight loss indications.
The above article was sent to subscribers in Pharmacy Daily's issue from 23 Apr 12To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 23 Apr 12
