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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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  • 26 Mar 2024 4:32 PM | Anonymous member (Administrator)

    Today’s tech alert (Click above) provides an update for members on the progress of the TGA’s Recall Reforms Program following public consultation in 2023 on potential changes to how product recalls are undertaken in Australia. 

    This alert provides information for members, including changes to TGA processes and changes to improve clarity and readability of the URPTG in response to stakeholder feedback and the TGA’s next steps in progressing the recall reforms.

  • 20 Mar 2024 11:08 AM | Anonymous member (Administrator)

    The TGA are introducing PIC/S Guide to GMP Version 16 (inclusive of Annex 13 and Annex 16), as the manufacturing principles for medicines from 3 June 2024 (PE009-16, 1 February 2022). Currently the TGA webpage does not discuss a transition however, CMA and other industry groups are discussing the length of a possible transition period with TGA.

    More information from the TGA including Version 16 interpretive guidance on complying with PIC/S, which will particularly address Annex 16/ Release for Supply concerns, will be released in June. In the meantime, manufacturers can refer to this Gap Analysis between Version 15 and 16 (member login required) to help understand how TGA expectations under Annex 16 will be mitigated in the forthcoming GMP interpretive guidance.

    For examplemany in the Complementary Medicine industry have been concerned about Annex 16 new clause 1.7.3 (audit reports are available to the Authorised Person performing the certification). The Gap Analysis includes numerous comments against this clause, including for Listed medicines that:

    The current supplier approval processes (questionnaires, testing of deliveries etc) would be considered sufficient ‘audit’ for listed medicines API manufacturer.

    There is currently no expectation that additional audits will be conducted of listed medicines contract manufacturers in the supply chain in addition to those inspections conducted by the TGA or other approved regulator. 

    It is deemed acceptable evidence for clause 7.4.1 that the contract manufacturer holds a TGA licence or certificate for the relevant steps in manufacture. 

    CMA has joined a joint TGA-industry Working Group of the TIWG, which will rewrite the Release for Supply guidances to modernise the documents, and in view of the introduction f Annex 16. Sector specific information including on listed medicines will be included. 

    To ensure the updated guidances will meet member needs, CMA is seeking your feedback on the following:

    - What concerns do you have with the current Release for Supply guidances* and what could be made clearer?

    - What questions or concerns do you have about Annex 16?

    - After considering the Gap Analysis, how long do you think the transition period should be and what specific internal/commercial factors influence this?

    - Do you have any other questions about Release for Supply to improve future guidance. Are there specific examples you would like covered in the guidance?

    Please send your questions, concerns or suggested examples to clarify in guidance to Lucy.Lang@cmaustralia.org.au as soon as possible.

    Further developments will be discussed with CMA's GMP & Manufacturing Committee, and CMA will send technical alerts when future TGA GMP guidances are published.

    *Release for supply of medicines | Therapeutic Goods Administration (TGA)

    Releasing medicines manufactured at multiple sites | Therapeutic Goods Administration (TGA)

  • 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.

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