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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.

  • 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.

  • 23 Jun 2022 9:00 AM | Anonymous member (Administrator)

    This information may be of interest to:

    -Research and academic institutions conducting clinical trials

    -Sponsors and other members sponsoring or involved in clinical trials

    The TGA will provide an overview of the new Guidance for GCP Inspection of clinical trial sites for investigational biologicals and medicinal products via an online webinar, to be held on Tuesday 28 June 2022, 1pm-2pmClick here to register.

    This webinar follows the recently published Guidance on the TGA website for Good Clinical Practice (GCP) inspection of clinical trial sites for medicinal products. The guidance describes how the TGA prioritise and schedule GCP inspections; the kinds of inspections the TGA might conduct; the inspection process, and how the TGA report and follow-up on inspections.

    While CMA is aware that currently the TGA prioritise inspections for high risk products such as prescription medicines or biologicals, meaning CM trials may not be inspected, the information at the webinar and in the guidance is nonetheless valuable for those conducting trials.

    CMA recommends attending the webinar that if you are conducting or sponsoring clinical trials for complementary medicines. Please also see CMA’s 28 April technical alert for more information.

  • 23 Jun 2022 8:48 AM | Anonymous member (Administrator)

    TGA's Industry- Only Consultation on Proposed Update to limited aspects of TGO 92 Labelling Order - Medicine Name presentation & 'distinguishing marks'

    *Privileged Government information for industry members only: Not authorised for copying, distribution or publication outside of your company*

    The following information may be of interest to:

    - Sponsors / brands, particularly those with s9(2) s14/14A consents from TGA

    - Any member interested in how medicine name and labels are presented for supply

    - Manufacturers releasing for supply

    Sponsors of complementary medicines currently have labelling restrictions in section 9(2) of the TGO 92 on how medicine names are presented in combination with distinguishing marks (may include registered trademark, a graphic image, icon or logo, a brand name, slogan or tagline), within or adjacent to the medicine name, which occurred as part of changes to TGO 92 that was introduced between 2016-2020.

    This means that brands may not be able to be presented optimally for commercial purposes, or existing formats may be non-compliant with the labelling standard.

    CMA has been working with the TGA for several years to help ensure that medicine name presentation can be preserved for medicine sponsors to ensure trademark use, label presentations, and protect export considerations. Many CMA sponsors have been provided consent to supply goods with existing medicine name presentation, since TGO 92 took full effect in 2020.

    The consultation newly released is intended to provide greater flexibility to industry on presenting labels that include distinguishing marks within or adjacent to the medicine name, provided that overall consumer identification of the product for recall or other purposes is not unduly affected. This is intended to ensure that those with existing s14/14A "consents to supply" for non-compliance with TGO 92 s9(2) will - in most, if not all circumstances - be considered compliant and therefore no longer need to obtain these after the update is implemented. This is intended to occur prior to the current expiration date of the notices on 31 August 2021.

    Please see details of the consultation in today's member alert.

    CMA appreciates all the member feedback on this issue to date and looks forward to finalising these issues with you in this industry consultation from TGA. We encourage members to consult with their legal departments on the proposed updates to ensure needs will be met.

    Please contact Lucy.Lang@cmaustralia.org.au and technical@cmaustralia.org.au with your feedback and responses to CMA preferable by COB Friday 15 July

    Members who received invitation to comment by the TGA have until COB Tuesday 19th July to respond to TGA.

  • 23 Jun 2022 8:41 AM | Anonymous member (Administrator)

    Evidence Guidelines for Listed Complementary Medicines: Version  4.0

    The TGA have finalised and published the updates Evidence Guidelines, Version 4 June 2022; How to demonstrate the efficacy of listed medicines is acceptable. 29 submissions were received to the consultation:

    - Industry Groups: 2

    - Regulatory agents: 3

    - Health care professional groups: 4

    - Research/Academic Institutions: 3

    - Individuals: 1

    - Consumer groups: 0

    The TGA have thanked CMA and members for the valuable contribution provided on this mutually important guidance and provided that all feedback has been carefully considered. Further information has been provided by the TGA on the purpose of the guidelines; the legislative basis and expectations; what they consider a critical appraisal, and evidence sources for traditional medicines.

    The updated guidelines also make it clear that the guidelines are not mandatory requirements but rather show sponsors what a TGA delegate considers in a compliance review and what will more likely result in a successful compliance review outcome.

    Further analysis for members on final outcomes will be published for regulatory and technical staff by CMA technical alert in coming days.

    Feedback from members, both now and on an ongoing basis as TGA compliance reviews occur, is strongly welcomed at technical@cmaustralia.org.au

  • 26 May 2022 1:47 PM | Anonymous member (Administrator)

    The TGA has published NEW guidance on their website today on the use of testimonials and endorsements in advertising.

    The guidance is a result of extensive questions and feedback or meetings with the TGA by industry bodies including CMA, sponsors, advertisers, and advertising agencies, to help clarify the intention of the updated Section 24 of the Therapeutic Goods Advertising Code 2021 (the Code) that began on 1 January 2022 and is expected for full implementation by 30 June 2022.

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

  • 24 May 2022 10:25 AM | Anonymous member (Administrator)

    Today's technical alert provides updated information for sponsors on upcoming changes to requirements of ingredients in the permissible Ingredients Determination:

     - Issues relating to ingredients that may be affected by TGO 95 (Child-resistant packaging standard) and actions sponsors should consider in relation to upcoming changes; and

     - Issues relating to identified discrepancies between ingredients and the Poisons Standard – changes to requirements in the Determination that will be made to a range of ingredients anticipated June-September 2022 and other future changes. Members must contact us if there are any issues or questions with the proposed new wording of the requirements for the list of changing ingredients.

    Please read the full alert for more information and details and contact us if you are unable to open the alert.

  • 17 May 2022 2:38 PM | Anonymous member (Administrator)

    This member alert provides a reminder that the end of the transition period for compliance with the 2018 Advertising Code is approaching, ending on 30 June 2022

    From 1 July 2022, advertisements must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.

    Please read today's full alert for more information on changes to the Code, including mandatory statements, health warnings and testimonials and endorsements; and TGA guidance and expectations. 

  • 02 May 2022 1:33 PM | Anonymous member (Administrator)

    The TGA has published an update to the TGA list of COBs on their webpage which outlines criteria and overview of the COB report-based process. 

    The TGA can use evaluation reports from comparable overseas bodies (COBs) to evaluate safety and/or quality and/or efficacy for the following pre-market applications:

     - registered complementary medicines

     - assessed listed medicines

     - substances for use as ingredients in listed medicines.

    Today’s technical alert provides more information, including a comparison of the 2019 list and the newly published 2022 list of COBs which outlines any changes or additions. 

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