Technical Alerts

CMA’s Technical Alert includes important advice from the TGA in relation to a condition of listing relevant to export-only medicines, also included is a spotlight on curcumin products which may be of interest to members.

Click here to read the Alert.

The Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2016 has been published to the Federal Register of Legislation. Consequently determination No. 1 of 2015 has been repealed.

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Ms Trisha Garrett, Assistant Secretary to the Complementary & OTC Medicines Branch will be moving to a new role within the Department this month....

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The New Zealand Government is developing a new regulatory scheme for low-risk natural health products. Consultation is now open on the proposals outlined in the consultation document and the draft papers. 

Members are invited to provide comments to this consultation for incorporation into the Australian response. Comments can be sent to submissions@cmaustralia.org.au up to the 22 January 2016.

The Therapeutic Goods Administration will update the listed medicine validation rules for herbal ingredients containing the component ‘coumarin’. An update will also be made for ‘thujone’ as a herbal component of Artemisia spp.

The validation rules for medicines containing these ingredients have been tightened to reflect SUSMP limits. These limits are also reflected in the 26BB Permissible Ingredients Determination, which commenced 1 January 2016.

In April this year, members were informed of the TGA listing compliance review outcomes for medicines containing the ingredient  Euphausia superba (Krill) Oil. At the time CMA provided information to assist sponsors to conduct a review of indication(s) for Krill oil and to voluntarily make any necessary amendments.

Having provided sponsors with the opportunity to make  amendments, the TGA will now follow up directly with sponsors of affected medicines.

Click here to read the Alert

Dear Member,

CMA is pleased to inform that 10 new ingredients have been assessed by the TGA as suitable for use in listed medicines.
The relevant Listing Notice permitting their use is now registered on the Federal Register of Legislative Instruments.

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The final version of the NHSP Bill Supplementary Order Paper, which is to go to Cabinet for final approval in early September, is currently open for consultation.
Comments on the Bill may be sent to Naturalhealthproducts@moh.govt.nz by Thursday, 27 August, 2015.

This Supplementary Order Paper amends the NZ Natural Health Products Bill.
The effect of these changes is that dietary supplements in NZ will be regulated as natural health products. See more detail in the Alert.

The China Food and Drug Administration have published three health food related regulations for comment, due by August 28, 2015.
The US-China HPA provides links to the translated versions of the regulations.

Click here to read the Alert

Recently, members would have received the outcomes of CMA member consultation on a range of new substances proposed for expedited evaluation. This body of work flows on from discussions CMA has held with the TGA in relation to leveraging off existing regulatory work, as well as work of other regulators, to deliver streamlined approvals of ingredients.

CMA is pleased to inform members that 10 new ingredients have been assessed by the TGA as suitable for use in listed medicines and, where required, compositional guidelines have been developed
A further 10 ingredients have been assessed as suitable for use in listed medicines, subject to compositional guidelines being developed.

Click here to read the Alert.