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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.

  • 31 Aug 2022 11:25 AM | Anonymous member (Administrator)

    The TGA has launched their new website at midnight on 30 August. The new site is intended to provide users with a more streamlined way to search for and access relevant information.

    The new website aims to deliver on improvements to:

    - how the website looks and works so it's easier to find and understand the information you need;

    - navigation and search so you can find what you need faster;

    - follow Government best practice; and

    - move old website content to be archived on the National Library of Australia web archive  (TROVE).

    Today's technical alert provides more details for members, including information accessing archived TGA content and superseded guidances (where relevant for historical purposes) on the National Library of Australia web archive (TROVE) and some limited documents on the CMA website.

  • 04 Aug 2022 10:29 AM | Anonymous member (Administrator)

    The TGA has published the annual low-negligible risk public consultation paper for changes to the Permissible Ingredients Determination, closing 15 September 2022.

    The proposed changes relate to:

     - Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata; and 

     -Liver injury associated with Valeriana officinalis.  

    The consultation proposes applying a new warning statement for Valeriana officinalis and an updated warning statement for Chelidonium majus and Larrea tridentata which are essentially the same except for the required name of the herb.

    Please read today’s full technical alert for more details and additional contextual information.

  • 03 Aug 2022 12:28 PM | Anonymous member (Administrator)

    A new Therapeutic Goods (Permissible Ingredients) Determination (No.4) 2022 commenced on Tuesday 2 August 2022.

    This Technical Alert contains all details of new, deleted and changed ingredients, and a comparison of all changes to the determination for members.

    This alert details:

     - NEW ingredients and specific requirements that apply to that ingredient

     - CHANGED ingredients with the original requirements and the new or changed requirements.

     - DELETED ingredients if applicable

    Notable changes for complementary medicines include a new EPA rich ingredient that has been approved subject to an exclusive use period by the applicant, and removal of an exclusive use period an for active ingredient that was previously approved. There are changes to be aware of in relation to clove oils, some homeopathic ingredients, some preservative ingredients, and other ingredients.

  • 27 Jul 2022 12:18 PM | Anonymous member (Administrator)

    The TGA has recently published an updated web page in relation to Nitrosamine impurities in medicines which includes details on sources, limits and quality references and a number of information sources for sponsors, manufacturers and raw material suppliers.

    Please read today's full technical alert for additional information and details for member consideration.

  • 26 Jul 2022 8:31 AM | Anonymous member (Administrator)

    The TGA has published a web page outlining new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 1 July 2022 to 30 June 2023, and includes matters relating to unapproved goods, e-commerce supply of unapproved goods; COVID-19 or serious diseases; sports supplements; and medicinal cannabis.

    In particular CMA has supported TGA deterring and addressing the unlawful advertising of unapproved therapeutic goods (goods not listed on ARTG when required) on e-commerce platforms to Australian consumers. CMA supports monitoring and deterring the supply of illegal and unauthorised therapeutic goods in Australia, including via representation on the Therapeutic Goods Advertising Consultative Committee (TGACC), which identified that the supply of unapproved therapeutic goods that advertised non-compliantly on e-commerce platforms presents a risk to Australian consumers and industry.

    This technical alert provides a summary of these TGA compliance priorities and includes additional information and resources where applicable or relevant, for member consideration. 

  • 01 Jul 2022 11:47 AM | Anonymous member (Administrator)

    The TGA has published Guidance on applying the Advertising Code rules on their website.

    From Today, July 1 2022, advertising for therapeutic goods that can be advertised to the public must comply with the requirements in the Act and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

    Parts of the Guidance are available in Word and PDF format until searchable webpage guidance resources are published on the new TGA website.

    Please read today’s full member alert for more information and details.

  • 30 Jun 2022 11:31 AM | Anonymous member (Administrator)

    The TGA will be conducting targeted compliance reviews of selected listed medicines that contain Andrographis paniculata to ensure the presence of required warning statements. 

    There are approximately 109 medicines containing Andrographis paniculata currently listed on the ARTG.

    This technical alert provides more details, including a recap of requirements and a number of resources providing further contextual information.

  • 30 Jun 2022 8:59 AM | Anonymous member (Administrator)

    Today's alert for members contains an assessment of the recently published Listed medicines Evidence Guidelines; a summary of CMA responses and outcomes; and a discussion of changes and issues for members to be aware of.

    A full comparison highlighting the changes between the final published guidelines and the draft consultation paper is also linked for members.

    We appreciate and welcome your ongoing member feedback and insights.

  • 29 Jun 2022 11:47 AM | Anonymous member (Administrator)

    The end of the requirement for formal pre-approval of therapeutic goods advertisements in June 2020 was the result of a long sought after approach by CMA and our industry members, as part of the review of Medicines and Medical Devices Regulations (MMDR), to reduce unnecessary red-tape and create an increased self-regulatory approach to advertising.

    The TGA expect compliance with advertising legislation including the Therapeutic Goods Advertising Code (as updated from time to time), but do not require that a third party service provider assess advertisements for compliance. However, since the abolition of the therapeutic goods advertising pre-approval requirements, some advertisers (such as retailers and third party websites) choose to request that other advertisers (such as medicine sponsors) use a third party review to help ensure the compliance of proposed advertisements across shared advertising platforms.

    In these situations, please be aware that the TGA does not mandate, require, nor endorse any particular review service, consultants or vetting servicesThe TGA have stated that they undertake their role with impartiality, and recognise that the best outcome for advertising compliance includes equitable communication and engagement across all their stakeholders.

    In summary, members should be aware that there are various avenues available to advertisers for a voluntary third party review of compliance of advertisements.

    CMA have a list of highly experienced regulatory affairs consultants included on the CMA Regulatory Affairs consultants webpage, whom can expertly help advertisers assess advertisements for compliance against legislation including the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

  • 28 Jun 2022 9:10 AM | Anonymous member (Administrator)

    Today's Technical Alert provides information for sponsors in relation to receiving TGA Notices of "Conditions of Listing". 

    CMA understands that the sending of the Notices by the TGA that are signed by a Delegate is a formalisation of applying the conditions of listing.

    Receiving a Notice should not remarkably affect sponsor activities, because the Notices contain the standard ongoing conditions of listing that sponsors are already familiar with as they are included on ARTG records at the time of listing.

    Please read the full tech alert for more details, including targeted industry consultation on moving the conditions into a Determination (legislative instrument) at a future date.

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