New TGA CM consultation
April 17, 2013

THE Therapeutic Goods
Administration is seeking
comments from interested parties
on new draft guidelines for
complementary medicines for use
in listed medicines.
It’s a proposed revision and
restructure of the current
‘ARGCM Part III: Evaluation of
complementary medicine’ and
although new procedures are
added, the existing document
contains “outdated information
which has been amended to reflect
current regulatory practice”.
The ARGCM provides information
for manufacturers, sponsors,
healthcare professionals and
the general public on the legal
arrangements for the supply and
use of complementary medicines in
Australia.
A staged consultation process for
the revised ARGCM will see each
of four draft sections published
separately on the TGA website,
with a four week consultation
period provided for each part.
Parts A and B have already been
published for consultation, in
late 2012 and in Jan-Feb this year
respectively.
The new document was released
for consultation yesterday, with a
deadline for responses of 14 May.
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