Questions about efficacy testing, non-compliance deterrents posed.
The panel conducting the Review of Medicines and Medical Devices Regulation has called for submissions from stakeholders regarding regulation of complementary medicines.
The panel, headed by Emeritus Professor Lloyd Sansom and announced last year (PD 27 Oct 14), released an addendum to its discussion paper today dealing with complementary medicines.
The chapter, which was flagged at the time of the Review’s announcement, asks various questions of stakeholders, including whether an ingredient should only be considered to have been ‘approved’ by an overseas regulator if it had been subjected to assessment, and if so, whether this assessment should include quality, safety and efficacy.
The document said while Canadian regulators undertook pre-market evaluation of ingredients in complementary medicines for quality, safety and efficacy, the US Food and Drug Administration only require notification of a new ingredient and demonstration of a reasonable expectation of safety for use in a dietary supplement.
“As such, ‘approval’ of a new ingredient in Canada means something quite different than ‘approval’ of a new ingredient in the US.
“In Australia, the TGA assesses quality and safety of a new ingredient, but does not undertake an assessment of efficacy.”
Other questions asked of stakeholders include whether Australia should adopt approval of ingredients by ‘trusted’ overseas regulators, whether the current regulatory regime for complementary medicines in Australia is commensurate with the risk posed by products, and whether low-risk complementary medicines should be regulated as general consumer goods, rather than having to be listed on the Australian Register of Therapeutic Goods.
The chapter also asks whether current legislation provided sufficient deterrents to prevent sponsors “knowingly listing non-compliant complementary medicines” on the Register, citing the fact that sponsors could request a product be removed from the Register if it is subjected to a review by the Therapeutic Goods Administration, and re-list it at a later date.
Submissions on the addendum are due by 08 Apr.
For more, see Monday’s Pharmacy Daily.
