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Technical Alerts

Technical Alerts

This section contains Technical Alerts for members only - to access restricted Technical alerts member login is required.

  • 01 Nov 2016 9:17 AM | Anonymous

    The TGA is expecting to release public consultation papers to allow feedback on the implementation of the recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR).

    This forecast shows anticipated consultations for Complementary Medicine Regulatory Reforms commencing in the October 2016 - March 2017 period.

    Click here for more. 
  • 31 Oct 2016 9:16 AM | Anonymous

    This Alert is to advise that the TGA has completed a safety evaluation of fennel oil, an ingredient used in a number of listed medicines. 


    Click here to read more.
  • 25 Oct 2016 9:18 AM | Anonymous

    The TGA has advised CMA to inform our members of the status of a chemical substance manufacturer, which may be of relevance to our members.

    The US FDA recently issued a warning letter to the Nippon Fine Chemical Company, an API and chemical substance manufacturer. The warning letter was issued due to the site’s personnel physically obstructing FDA inspectors and refusing to hand over documents for review. The FDA has also placed the site on import alert.

    No medicines supplied in Australia nominate this site for API manufacture, however, the TGA is aware that some excipients may be sourced from there.

    The TGA request that CMA members verify with your manufacturers whether any raw materials for their medicines are sourced from the Nippon Fine Chemical Company, and if so, undertake a risk assessment in light of the warning letter.

  • 12 Sep 2016 2:30 PM | Anonymous

    Health Canada is examining new approaches to the regulation of natural health products (self-care products), including refocusing the approval of health claims to those based on scientific evidence. 

    The Health Canada online consultation for the Regulation of Self-Care Products is open through to 24 October, 2016.

    Click here to read the Alert 
  • 02 Aug 2016 11:35 AM | Anonymous

    The Therapeutic Goods Permissible Ingredients Determination No.2 of 2016 is published and includes 205 amendments to ingredients for use in listed complementary medicines.

    A summary of the main changes is outlined as well as related resources for members.

     Click here to read the Alert
  • 26 Jul 2016 9:30 AM | Anonymous

    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.

  • 02 May 2016 10:59 AM | Anonymous

    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.

    Click here to read more.

  • 03 Feb 2016 1:44 PM | Anonymous

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

    Click here to read the technical alert

  • 05 Jan 2016 2:24 PM | Anonymous

    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.


    Click here to read the Alert  
  • 04 Jan 2016 1:27 PM | Anonymous

    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.


    Click here to read the Alert

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