THE Therapeutic Goods Administration has published updated guidelines on the evidence required to support indications for listed complementary medicines.
While evidence requirements have not changed in the new version, it now includes a list of permitted indications from which AUSTL listed medicines must exclusively draw, incorporating changes to the regulatory framework from listed medicines arising from amendments to the Act in Mar 2018.
The guidelines also now detail the additional "AUSTL(A) assessed listed" pathway providing an option for listed medicines to make higher level indications, when efficacy has been assessed by the TGA.
See www.tga.gov.au.
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