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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.

  • 11 Dec 2017 1:31 PM | Anonymous

    The TGA has released a new Child-resistant packaging requirements for medicines, the Therapeutic Goods Order No. 95, which will replace the TGO 80. More information is available here.

  • 04 Dec 2017 1:32 PM | Anonymous

    The TGA has released a fifth Permissible Ingredients Determination for 2017, which is now included on the Federal Register of Legislation (FRL). It includes one new active probiotic ingredient for Listed Medicines. A combined volume of the six volume determination is included for CMA members in this update.

    An amendment to the Therapeutic Goods Regulations has also been included on FRL, which allows for new kinds of notifications for Registered Complementary Medicines. The TGA Business Services online portal and guidance has been updated accordingly. For more details and links please click here.
  • 28 Nov 2017 1:32 PM | Anonymous

    The TGA has released information regarding the transition to the new PIC/S GMP code, including transitional arrangements and the effects upon manufacturing audits. A restructure of manufacturing fees and charges has been flagged and will be consulted over the coming months. For more information, please click here.

  • 17 Nov 2017 1:33 PM | Anonymous

    Today the TGA released a public consultation proposing significant changes to the regulation of Herbal Component Names. Find more information and a summary of the details here.

  • 15 Nov 2017 1:34 PM | Anonymous

    Please find a further update regarding permitted indications, including regulatory policy considerations, and the current discussion around biomarker claims. The technical alert is included here.

  • 15 Nov 2017 1:34 PM | Anonymous

    The Federal Register of Legislation has been updated to allow low-THC hemp seeds and hemp seed products as foods under the Food Standards Australia New Zealand Food Standard. However, restrictions under the Poisons Standard may still apply under Australian State and Territory and NZ law.

    For more information, please click here.

  • 31 Oct 2017 1:37 PM | Anonymous

    The attached technical alert contains details of the revisions to the permitted indication list, details around requesting an extension if desired, and the proposed implementation including future applications for indications.


    CMA has made the following submission regarding intentional omissions or changes to the existing Listed medicine system. CMA did not repeat general indication requests made by individual members as the TGA has provided that each submission would be fully assessed and repetition would slow down the process.

    Biomarker / biological substrates

    Maternal health and infancy

    Traditional qualifiers

    Mild and Medically Diagnosed including BPH, etc.

  • 04 Oct 2017 1:38 PM | Anonymous

    As recently discussed at CMA Board and Regulatory Policy meetings, we believe the Amendment Bill for the reformed framework to complementary medicines is a beneficial move forward for the complementary medicines industry.CMA has identified a few items for amendment to improve the overall outcome. The proposed amendments are minor in nature, there is no intent or likelihood of preventing Bill passage. As agreed, CMA has produced a template letter to the Minister on behalf of member sponsors* to create a broad industry show of support for these small amendments with important positive impacts. To access the letter, you will need to be logged in as a member to the CMA website.
     
    If in agreeance, please return a finalised letter signed by a company representative to Lucy.Lang@cmaustralia.org.au by COB Monday, 9 October, for presentation to the Minister by CMA.

                                        

    *Please note the template and information within is for use of CMA members only and may not be reproduced or re-distributed.
  • 28 Sep 2017 11:36 AM | Anonymous member (Administrator)

    Release of Consultation Document – New Assessment Pathways


    The TGA has released its ‘Consultation: Business process improvements supporting complementary medicines assessment pathways’. It details new business processes associated with regulatory reforms for Complementary Medicines, which are under implementation in response to the Medicines and Medical Devices Regulation (MMDR) Review. The consultation contains a broad amount of information relating to the TGA’s new ‘risk-based approach to regulating complementary medicines: three assessment pathways’, and includes the following topics and questions.


    Please click here to read the alert

  • 27 Sep 2017 1:39 PM | Anonymous

    The TGA has just released its Consultation: 'Business process improvements supporting complementary medicines assessment pathways’ with further details on the new pathway and new processes applicable under regulatory reform. Additionally, it has released the new GMP Clearance Application e-forms. For further information please click here.

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