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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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  • 19 Mar 2024 9:35 AM | Anonymous member (Administrator)

    The Department of Health and Aged Care (the Department) is conducting a Public Consultation on the final stage of the FSANZ Act Review, closing 10 April 2024.

    The FSANZ Act Review has identified 27 concepts across four themes for further investigation, which have been consolidated into 20 components in an Impact Analysis. Stakeholders are being asked for their views on the Impact Analysis and to provide feedback to characterise the impact of the proposed concepts. 

    Please read today’s full alert for more information, including aspects of the review that may be of potential interest to members such as:

    - Definition of ‘public health and safety’ in the Act.

    - Potential approaches toward a risk based framework.

    - Potential new pathways to amend food standards.

    - Potential to bring more Traditional Foods to market.

    - Industry guidelines to guide interpretation of food standards.

  • 15 Mar 2024 1:41 PM | Anonymous member (Administrator)

    The TGA has released public consultation on new proposals to amend the Poisons Standard in relation to:

    - Amygdalin and hydrocyanic acid, providing a new cut-off limit effecting approximately 21 ingredients that is likely to give some greater certainty to industry and practitioners around the supply of products, cosmetics and raw materials with very low trace levels; and 

    - a relate new  Schedule 10 entry for Wild Cherry Bark, effecting a total ban on Wild Cherry Bark for therapeutic use

    The same consultation paper proposes cautionary statements for those Green Tea/Tea (Camellia sinensis) products that are not already on the ARTG and not in foods.

    Sponsors, manufacturers, raw material suppliers, practitioners and other affected stakeholders are encouraged to read this full tech alert  for:

    - important clarifying information on these proposals that CMA has obtained,

    - specific information relevant to practitioners,

    - background information,

    - CMA’s draft positions, and

    - details on how to effectively respond to the consultation.

    This tech alert is publicly accessible and the link is permitted to shared with practitioner and other interested stakeholders

  • 01 Mar 2024 11:25 AM | Anonymous member (Administrator)

    new Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024 commences today, Friday 1 March 2024.

    This technical alert provides members with a summary of changes as well as a comparison table of all changes to the Determination.

    Important changes in this Determination include:

    NEW ingredients for use in listed and assessed listed medicines and specific requirements that apply to those ingredients:

    - Addition of the new active ingredient theanine with exclusive use provisions for 2 years;

    -Addition of the new excipient ingredient ceramide 6 II;

    Addition of the new excipient ingredient sodium lauroyl lactylate; 

    CHANGED ingredients including ingredients with NEW WARNINGS and other changed requirements:

    - Curcuma aromatica; Curcuma longa (Turmeric); Curcuma zanthorrhiza; Curcuma zedoaria; and curcumin.

    - Camellia sinensis (Green tea).

    Ingredients with important changed requirements including

    - Terminalia ferdinandiana (Kakadu plum); neohesperidin-dihydrochalcone (permitted for oral use in listed and listed assessed medicines); hemp seed oil, and other ingredients.

    Please read today’s full alert for more details.

  • 28 Feb 2024 8:55 AM | Anonymous member (Administrator)

    The Federal Register of Legislation (FRL) website was recently updated in early 2024. The FRL is the approved, whole-of-government website for Australian Government legislation and related documents.

    Navigating some legislative documents on the FRL is necessary for all business areas required to access legislation relevant to their core business including Regulatory, Legal, Marketing, Manufacturing and Innovation.

    This Member Alert provides a summary of information that may be of use to members in navigating the new FRL.

  • 22 Feb 2024 3:41 PM | Anonymous member (Administrator)

    The TGA has published a safety advisory regarding emerging gastrointestinal adverse event reports associated with the ingredient Withania somnifera (also known as Ashwagandha).

    Please read today’s member alert for more details, including additional information and insights for member consideration and regulatory response.


  • 08 Feb 2024 10:21 AM | Anonymous member (Administrator)

    Further to CMA's 6 February 2024 tech alert on the TGA's proposal to adopt certain international scientific guidelines in Australia, this alert is updated to include further information on the relevance of 11 of the 13 proposed international scientific guidelines to some Listed, Listed Assessed and Registered Complementary Medicines, and some New Substance (or changed substance) applications. Updates are included in green highlights.

    Residual Solvents

    Raw Material Suppliers, Sponsors and Manufacturers should review the following information

    All Listed Medicines that are subject to the TGO 101 (tablets, capsules and pills) will need to apply the ICH Q3C as it is incorporated in Ph. Eur. 5.4 referred to in Section 16(2) of the TGO 101.

    As noted in this alert, CMA has included a comparison of the current Q3C (R6) and the proposed Q3C (R8) documents. The changes predominantly relate to:

    - The removal of methyltetrahydrofuran from Table 4. -  Solvents for which no adequate toxicological data was found.

    - The addition of Part VI: PDE for 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tertiary-Butyl Alcohol (pp 41-51).   

    - Cyclopentyl Methyl Ether: 15.0 PDE (mg/day); 1500PPM

    - Tertiary-Butyl Alcohol: 35 PDE (mg/day); 3500PPM

    - 2-Methyltetrahydrofuran 50 PDE (mg/day).

    Members are encouraged to review the information in this tech alert  and the guidelines to determine suitability to complementary medicines within Australia and provide any relevant comment to CMA by 28 Feb and/or through the TGA public consultation survey, which closes 4 March 2024

    Please read today’s update  for more details.

  • 06 Feb 2024 8:15 AM | Anonymous member (Administrator)

    The TGA have published a consultation, closing  4 March 2024, on proposals to adopt certain international scientific guidelines. This technical alert provides a summary of each of the proposed guidelines that are relevant to Listed medicines, and are likely to be of relevance to new applications for new (or changed) substances for listed medicines and Listed Assessed, or Registered complementary medicines.

    Members are encouraged to review the information in this tech alert and the guidelines to determine suitability to the complementary medicine applications within the Australian regulatory framework.

    Please read today’s full tech alert for more information, including a comparison of current and proposed guidelines that are applicable to all complementary medicines, and details on how to respond to the consultation.

  • 01 Feb 2024 1:06 PM | Anonymous member (Administrator)

    The TGA has published a web page providing information on the updated TGA acceptable intake (AI) for nitrosamine impurities in medicines.

    The update includes the addition of internationally determined AI limits for Calcium folinate / Calcium levofolinate, which is listable complementary medicine ingredient.

    Please read today’s full alert for more details, including additional background information on the TGA’s approach to nitrosamine impurities in medicines.

  • 30 Jan 2024 1:48 PM | Anonymous member (Administrator)

    The TGA is conducting a public consultation, closing Friday 23 February 2024, on the TGA’s proposed increase to fees and charges for the 2024-25 financial year by a total of 6.71% for medicines and 6.30% for manufacturing licenses.

    This member alert provides further information on the TGA Fees and Charges Proposal 2024-25, which describes the reasons for the proposed fee increases, including an increase of the indexation factor by 4.7% and the proposal to apply additional percentage increases on fees and charges relating to digital transformation costs among others, and additional information about TGA cost-recovery framework and public interest activities. It also includes information on a future major review of fees and charges.

    The TGA have stated they prefer consolidated industry feedback through representative peak bodies such as CMA, so that the overall industry view can also be considered before finalising next financial year's fees and charges. CMA is developing a position based on knowledge of TGA regulatory activities and performance, and Committee and member feedback.

    Members may provide any feedback to the consultation to CMA by Mon 19 Feb2024 via technical@cmaustralia.org.au and respond to the public consultation independently based on the details in this alert.

  • 15 Jan 2024 11:54 AM | Anonymous member (Administrator)

    In March 2023, the TGA introduced new label advisory statements for Valerian (Valeriana officininalis, Valerian dry, Valerian powder), Greater Celandine (Chelidonium majus), or Chaparral (Larrea tridentata), following a decision announced in December 2022.

    The 12 month transition period for existing medicines that contain these ingredients is coming to an end. All existing products with these ingredients that are released for supply from 1 March 2024 must include the label advisory.

    Please read this tech alert for details.

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