Subscribe


PD breaking news – Medicines Regulation inquiry calls for comp meds submissions

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.


The above Breaking News Alert was sent to Pharmacy Daily subscribers on 20 Feb 15

Make a comment...



Established in 2007, Pharmacy Daily is Australia's leading pharmacy industry publication, and is sent as a free subscription to people across the industry as a PDF newsletter every weekday.

Register for Pharmacy Daily trial subscription

To sign up for a free subscription, click on the button at right.

Click here to see a sample issue of Pharmacy Daily.

Click here for more information on subscriptions.

Alternatively, you can search our site via the search box on the right hand side of the page, or find other content below.

Recent Pharmacy Daily articles

24 Aug

Travel Specials 24 Aug 17 - MSC Cruises upgrade: Italian cruise line MSC ...


24 Aug

Dispensary Corner 24 Aug 17 - ROUGHLY 5,000 ecstasy pills heading for Berlin ...


24 Aug

Carbimazole update - THE Therapeutic Goods Administration has advised the ...


24 Aug

AMA on codeine - AUSTRALIAN Medical Association president Michael Gannon has ...


24 Aug

Symbion seminars - SYMBION is hosting a series of forums ...


24 Aug

Heat celebrity deal - HEAT Doward has secured the distribution rights ...


24 Aug

CHF urges primary reform - PHARMACISTS should be "better equipped to work ...


24 Aug

EBOS reports record profit - EBOS Group Limited this morning released its ...


23 Aug

G&M Australian Lanolin Oil Cream MKII - G&M Australian Creams are made from iconic ...


23 Aug

Dove Body Silk Moisturising Cream - DOVE Body Silk Moisturising Cream contains a ...


23 Aug

Botanique Restore & Shine Shampoo - INFUSED with coconut milk and aloe vera, ...


23 Aug

Princess Power by Vera Wang - VERA Wang Princess Power is an energetic, ...


23 Aug

Dispensary Corner 23 Aug 17 - LOOKING for some young blood - that's ...


23 Aug

No business like snow business! - ATTENDEES at this year's Pharmacy Snow Business ...


23 Aug

Fishy cannabis? - A new business called Medical Organic Cannabis ...


23 Aug

Doctors repay $395k - THREE doctors have been ordered to repay ...


23 Aug

Pfizer probe outcome - PFIZER says the mix-up of heparin and ...


23 Aug

Pharmacist named Qld rural ambassador - CHRISTIE McLennan, owner of Taroom Pharmacy in ...


23 Aug

Bowles resigns - PRIME Minister Malcolm Turnbull yesterday accepted the ...


23 Aug

APC regos open - REGISTRATIONS for the upcoming Intern Written Exam ...



Show Pharmacy Daily items by month: