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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.

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  • 21 Jan 2021 1:12 PM | Anonymous member (Administrator)

    A new Therapeutic Goods(Permissible Indications Determination (No. 1) 2021 has been approved by the TGA delegate and is now available on the Federal Register of Legislation. 

    The addition of 3 new indications to the new Determination means that sponsors may, if they wish, make additional fee-free changes to their indications on the ARTG entries before the end of the transition period for permitted indications on 5 March 2021.

    In addition, there are other minor changes expected to reduce regulatory burden. A total of 16 changes appear in the Determination. A summary of the changes includes:

     - 3 new indications

     - Broadening the wording of the required label statement for 11 indications

     - Broadening the evidence base for one indication

     - Combining two duplicative indications into one indication

    Please read today’s technical alert and the information on the TGA website to be aware of the changes, particularly, the changes to the <VIT> warning statement.

  • 14 Jan 2021 8:37 AM | Anonymous member (Administrator)

    The TGA have released the public consultation on discontinuing new applications for Proprietary Ingredients (ingredient mixes) in the Proprietary Ingredients Table, specifically for Active Ingredient mixes (such as ingredients containing vitamins or minerals), Active Herbal mixes, as well as the non-specific excipient category (other excipient mix categories are unaffected).

    PIs are blends of ingredients that the supplier enters into the TGA database and obtains a number which sponsors can then use to add those ingredient mixes to their ARTG listing (or registration).

    Please read today’s technical alert for more information, noting that this alert contains important information relevant to CMA members that is not included in the public consultation document.

    n particular, there is information about the member response to the consultation, and further information about potential effects. We welcome all member feedback by Committee and also offline.

  • 06 Jan 2021 10:38 AM | Anonymous member (Administrator)

    The TGA is seeking comment on the content, presentation and usability of two draft efficacy monographs that have been developed for vitamins B6 and B12 in response to Recommendation 46 from the Review of Medicines and Medical Devices Regulation (MMDR).

    These monographs document evidence which substantiates the use of these vitamins for particular indications which are appropriate for listed medicines.

    The consultation period on these monographs closes 5:00 PM Friday 26 February 2021.

    Please see today's technical alert for more information on the consultation and potential sponsor impacts.

  • 06 Jan 2021 10:34 AM | Anonymous member (Administrator)

    Today's technical alert provides information for members on current and upcoming consultations, including:

    - Evaluation of Country of Origin Labelling regulations for food

    - TGA hemp seed oil down-scheduling consultation

    - Upcoming FSANZ Caffeine Review June 2021.

  • 16 Dec 2020 8:14 AM | Anonymous member (Administrator)

    A new Permissible Ingredients Determination (No.4)2020 has commenced.

    This technical Alert (available in Word or PDF) contains a detailed list of changes with a Notes field for sponsors to use to assist in identifying the changes relevant to products, as part of a table which includes

    -Each new or changed ingredient

    The original (previous) requirements that applied

    New (amended) specific requirements.

    This update also includes information on the following substances with more context provided for members on background information leading to the changes: 

    - Fallopia multiflora (He Shou Wu or Fo-Ti)

    - Arbutin-containing herbs updated to reflect the poisons Standard and increase market access

    - Change of transition periods from 'supply' to 'release for supply'

    - Other changes to the Determination, including the addition of 27 new ingredients and the expiration of exclusivity on 3 ingredients

    In addition, this technical alert includes information on:

     - Targeted industry consultation via CMA on TGA-proposed removal of Gynura japonica from the Permissible Ingredients Determination in March 2021 (closes via CMA on 6 January 2021).

    Proprietary Ingredient Consultation delayed until January 2021

  • 15 Dec 2020 2:32 PM | Anonymous member (Administrator)

    Today the TGA announced a final decision to down-schedule certain low dose cannabidiol preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

    The decision allows low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been pre-approved by the TGA, to be supplied over-the-counter by a Pharmacist without a prescription provided certain controls are followed. Please read today's member alert for more information, including:

    - The summary effect of the decision for the public

    - A full overview of the scheduling decision

    - Information for sponsors interested in pursuing clinical research and registration applications

  • 14 Dec 2020 3:21 PM | Anonymous member (Administrator)

    The TGA are proposing draft "Mandatory"(legislative) Data Requirements  for new substances that undergo evaluation to be entered into the Permissible Ingredients Determination to be used in listed medicines. 

    CMA are seeking both member feedback on the proposed mandatory data requirements and expressions of interest for industry member representation on one (or more) of the TGA’s Industry Feedback Groups on the proposed requirements.

    This consultation is NOT intended to go public, therefore it is important that CMA receive your member feedback so that we are able to respond to the TGA's proposal and help prevent any issues arising for industry in the future.

    Member feedback requested by Tuesday 19th January 2021  

    Expressions of interest requested by C.O.B. Thursday 7th January 2021 

    Please read today's technical alert for more details. 

  • 14 Dec 2020 12:31 PM | Anonymous member (Administrator)

    CMA are pleased to inform members that updated country of origin regulations are now in effect through the passage of the Competition and Consumer Amendment (Australian Consumer Law-Country of Origin Representations) Regulations 2020 on 10 December 2020.

    The passage of these Regulations represents years of work for the Complementary Medicines industry and provides stronger protections for industry by strengthening Country of Origin laws. The regulations prescribe, by law, a process of substantial transformation, rather than providing an example of a process that results in substantial transformation.

    The regulations do not, at this stage, require industry members to undertake any technical change or different approach to that which has been taken under the existing safe harbour laws and the initial introduction of 92AA of the Regulations in December 2019. However, members should note that the progress of other changes to labelling where voluntary country of origin representations are made is still under Government consideration and may result in further changes in 2021.

    Please read today's member alert for more information.

  • 11 Dec 2020 12:03 PM | Anonymous member (Administrator)

    Complementary Medicines Australia is pleased to announce that a new and improved Data Protection scheme for complementary medicines has entered Parliament as part of the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020.

    CMA hopes that a new, improved, and fully functional data protection scheme will be a landmark historical turning point in the research and therapeutic claims landscape for complementary medicines, not only allowing better advancement of the Australian sector, but as one that could serve for increased global advancement of models into the future that help stimulate and create recognition into research into non-patentable natural substances. This includes use in important health conditions as well as enhancement of wellbeing.

    The updated data protection scheme will enable researchers and sponsors to publish information and important details about their research in full, five years earlier than previously permitted, to gain earlier public recognition of the efficacy of vitamins, minerals, herbal and other complementary medicines.

    The new scheme also critically increases the flexibility and breadth of the scheme by expanding the eligibility of indications to ensure that a medicine with the same “intermediate” indication as another medicine but with different active ingredients, may also now access the scheme, to provide far greater certainty and be more effective in encouraging innovation into new therapeutic uses.

    A more effective data protection scheme combined with early, visible publication of the evidence-base for complementary medicines is particularly exciting as this recognition may occur in the context of more well known and accessible therapeutic uses including uses relating to certain health conditions currently not permitted to be included on other listed medicines

    For more information and details on the updated scheme, please see today's Member Alert

  • 08 Dec 2020 10:22 AM | Anonymous member (Administrator)

    The TGA update to ARTG summaries for listed medicines for both sponsors and the public has been implemented. The changes have now gone live and will be visible. This update will ensure that when herbal ingredients and active proprietary ingredients are used in listed medicines, the information about the active ingredient will be displayed more clearly.

    Please see CMA’s 25 November member alert for more information.

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