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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.

  • 15 Jul 2019 2:53 PM | Anonymous

    Turmeric, Black Cohosh, and Green lipped mussel are in the spotlight for possible adulteration or contamination issues. These are or will be the focus of TGA Laboratory testing programs for listed medicines.

    Members should be aware that under MMDR reforms, the TGA are taking a tougher stance across all therapeutic goods industries, and therefore it is likely that any negative findings would result in compliance or enforcement actions.

    Testing may occur for synthetic dyes, heavy metals including lead, and other possible contaminants, as well as correct herbal species identification by chromatographic profiling.

    As foreshadowed at the CMA Innovation Day, the online database HPTLC Atlas, or 'International Atlas of HPTLC Methods of Identification of Herbal Drugs', has now been launched by the International Association for the Advancement of High Performance Thin Layer Chromatography. Information is searchable and available for free download.

    For full details and links, members may view or download today's technical alert here.

  • 10 Jul 2019 2:54 PM | Anonymous

    The TGA have released three publications:

    • guidance regarding applications and permission to use restricted representations in advertising;
    • e-learning modules to assist sponsors in using permitted indications in their listings; and
    • a compositional guideline for Streptococcus salivarius.

    Members can read more about these publications in today's technical alert  here.

  • 08 Jul 2019 10:44 AM | Anonymous

    The TGA Laboratories will be testing herbal medicines that may contain arbutin. The limit of arbutin in therapeutic goods that are finished products is 25ppm. Below this concentration, supply is legal, above this concentration, products would face regulatory compliance actions.

    Please note that the down-scheduling application for arbutin remains under TGA assessment and will not be finally determined until 2020 or 2021.

    For more information and a list of possibly affected herbs, please find today's technical alert here.
  • 03 May 2019 2:38 PM | Anonymous

    The TGA have provided safety alerts in relation to two herbs, Vitex agnus-castus and the potential for interaction with oral contraceptives pills, and the Chinese medicine herb Fallopia multiflora (he shou wu) in relation to cases of adverse liver events.

    More information, including the possible future outcomes for medicines containing these ingredients from TGA safety reviews to be aware of, is included in today's technical alert here.
  • 26 Mar 2019 10:47 AM | Anonymous

    The TGA has launched:

    - New functionality within the ELF system for listed medicine applications;

    - A new online application system for AUST L(A) listed assessed medicines;

    - An updated User Guide for online applications of AUST L and L(A) medicines.

    For more details, please click here.
  • 22 Mar 2019 1:21 PM | Anonymous

    The TGA have provided an early copy of the final, NEW Standard for Tablets, Capsules and Pills, the "TGO 101". This replaces the TGO 78 as of next Sunday, 31 March 2019. Some new requirements have a 2 year transition period.

    A copy of the final version of the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG0 101) Order 2019 is not yet published on the TGA website but is linked to within this alert.

    We recommend members familiarise themselves with the changes and new requirements as outlined in the document and summarised in this Technical Alert.

  • 19 Mar 2019 1:22 PM | Anonymous

    The Department of Agriculture and Water Resources are experiencing delays in assessing import permits for a variety of animal and biological product import permit applications, including those that affect complementary medicines.

    Details of processing times and tips for businesses to improve application processing timeframes and outcomes are included in the alert here.

  • 08 Mar 2019 1:22 PM | Anonymous

    The second list of permitted indications has been published by the TGA, titled the Therapeutic Goods (Permissible Indications) Determination (No 1.) of 2019.

    This second Permissible Indications Determination includes new indications for sponsors, and other changes, notably re-instated label warning statements.

    The TGA have also published additional information on the outcomes of the permissible indications consultation, including a list of some of the industry-proposed indications from the consultation that are not currently included in the Determination.

    More details for sponsors, including key changes for sponsors, are here.

  • 21 Feb 2019 1:23 PM | Anonymous

    There has been a change of leadership at the National Institute of Integrative Medicine, with CMA commending the inaugural CEO, Mr Steven Bunce on his commitment and leadership in growing this high quality integrative medicine and research facility.

    The TGA have announced an update to the Permitted Indications Determination, with the second version being released this month. The new Determination features new permitted indications, some changes to indications, and changes or additions to label advisory statements. For more information, please read our technical alert here.

  • 04 Feb 2019 1:31 PM | Anonymous

    The TGA is updating the Evidence Guidelines for Listed Medicines in two phases in 2019:

    Phase 1: An administrative update (newly released today) to reflect permitted indications.

    Phase 2: Review of the guidelines to increase clarity (but not change the levels and kinds of evidence), with public consultation in 2019.

    More information here.

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