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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.

  • 11 Mar 2021 4:49 PM | Anonymous member (Administrator)

    The new $30 million Commercialisation Fund under the Modern Manufacturing Strategy is now open for applications.  

    The Fund will support project collaborations between industry and research partners by providing matched grants to Australian manufacturers to assist with commercialising new products and processes.

    The Fund will run over an 18-month period, with the first round of funding (opened today) providing $20 million, and a subsequent round delivering the remaining $10 million.

    Please read today's member alert for more details, including eligibility criteria and how to apply.

  • 26 Feb 2021 12:43 PM | Anonymous member (Administrator)

    A new Permissible Ingredients Determination (No. 1) 2021 has commenced.

    This technical Alert (available in Word and 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:

     - Updates to applicable requirements for inorganic magnesium salts, Andrographis paniculata and caffeine 

     - Removal of Gynura japonica 

  • 26 Feb 2021 12:09 PM | Anonymous member (Administrator)

    The Modern manufacturing Initiative is now open for medical product manufacturing projects that meet eligibility under its Translation and Integration streams. Applications for both streams close on 29 March 2021 5pm (AEDT).

     -The Manufacturing Translation Stream provides businesses with funding to support projects that translate high quality research into commercial outcomes and support businesses to scale-up and be more competitive and resilient. It provides co-funding to support businesses to adopt new technologies and improve their manufacturing processes to boost productivity and competitiveness.

     - The Manufacturing Integration Stream supports projects that integrate Australian businesses into domestic and international value chains, propelling their goods and services into new markets. It provides co-funding to encourage linkages between local businesses and domestic and international firms, increasing scale, supply capacity, and the ability to innovate. It will also facilitate the adoption of product standards and greater sharing and transfer of knowledge.

    Please read today's member alert for more information, including eligibility criteria and how to apply.

    Subscribe to manufacturing Strategy Updates here.

  • 24 Feb 2021 8:46 AM | Anonymous member (Administrator)

    The NHMRC are conducting a Review of the 2013 Australian Dietary Guidelines, a multi-phase process with the final step resulting in publication of updated Dietary Guidelines in 2024. 

    The current guidelines make community recommendations on dietary sources and approach to fruits, vegetables, salt, sugar, processed foods, types of fats etc. As part of the review process, NHMRC will consider how the current Guidelines are used and who is using them. Feedback from stakeholders, including those involved in product research and development, manufacturing and marketing is sought.

    As part of their primary scoping activities to ensure relevant information is considered and prioritised for inclusion in the review, the NHMRC have published a scoping survey on their website and are seeking comments on:

     - how the 2013 Australian Dietary guidelines are used; and 

     - topics to be considered and possibly in the review of the  Guidelines.

    The survey closes 3PM (AEDT) on 15 March 2021. Questions are a combination of multiple choice and open-ended questions and the survey will take approximately 15 minutes to complete. Responses will be collected anonymously, combined and the results published on the NHMRC website. 

    Following the conclusion of the scoping survey, the NHMRC will establish and appoint members to an Expert Committee to provide advice. the Expert Committee will be provided with the survey findings which will assist members to determine the priority topics for review. the Expert Committee will also prepare the research questions, support review of evidence and draft updated Guidelines.

    For more information, timelines, and to subscribe to keep up to date with the latest Review, ant to access the Dietary Guidelines Stakeholder Consultation Plan and scoping survey, please click here.

    For more information on this survey, please contact the NHMRC Dietary Guidelines team:dietaryguidelines@nhmrc.gov.au

  • 23 Feb 2021 8:48 AM | Anonymous member (Administrator)

    CMA is pleased to announce that the Therapeutic Goods Amendment (2020 Measures no. 2) Bill 2020 was passed in both houses of Parliament without amendment on 18 February 2021. This Bill introduces a 5-year data protection regime for clinical trial information used to support the TGA efficacy-assessed listed medicines, known as 'Assessed Listed' or L(A) complementary medicines. This protection of data, in effect, will:

     - prevent generic ‘copy’ AUST L(A) versions of approved medicines from being marketed, thereby ensuring the investment into clinical research reliably generates a commercial return for the sponsoring company.

     - incentivise clinical research and public recognition of the efficacy of complementary medicines

     - assist to grow the scientific evidence base for complementary medicines

    Please read today’s member alert for more information on Data Protection for L(A) complementary medicines, in addition to an update on the progression of funding rounds for the Modern Manufacturing Strategy streams.

  • 19 Feb 2021 9:57 AM | Anonymous member (Administrator)

    The TGA have recently published information on their website in relation to the recall of Artemisia annua and Artemisia absinthium products.

    Please read today’s technical alert for more comprehensive information and details surrounding this issue and in particular, important CMA advice and information for sponsors of herbal medicines to consider.

  • 12 Feb 2021 9:54 AM | Anonymous member (Administrator)

    There are 3 weeks remaining until the final date to transition to permitted indications on 5 March. There are approximately 13% of all listed medicines remaining to either transition or be cancelled.

    From member inquiries and TGA feedback, CMA would like to update members on the following key information to be aware of:

     - Please make the transition before the 5 March if you are able. Leaving the change to the last few days may risk problems with a slow TGA IT system or validation issues with your product.

     - If you are waiting to transition, please ensure you have a draft listing which has been successfully validated (refer to the Application and Submission User guide). This should help to avoid last minute issues for medicines failing to validate, which could risk them being inadvertently cancelled on 6 March if time is needed to ensure the listing meets all validation requirements. Cancellations of medicines on the 6 March are unable to be appealed so it will be important to prevent unexpected issues arising.

     - Please be aware that some retailers may check to see whether there are current listings on the ARTG when assessing their inventory. It is prudent to change a listing to permitted indications to keep the AUST L listing active on the ARTG if you are concerned about retailers stock-keeping. However, changing to permitted indications on or before 5 March remains free, meaning that a listing can stay active until the expiry of the annual charge already paid by the sponsor, to the end of June. At this time sponsors may choose to cancel their products or pay the annual charge for the next year.

     - Sponsors should retain evidence of submitting their application to transition to permitted indications on or before 5 March 2021.

     - If you are intending for a discontinued medicine to be automatically cancelled by the TGA on 6 March, please be aware that it may be preferable to cancel your own medicine, if you do not wish for the cancellation to appear on this TGA cancellation webpage. 

     - From 6 March, changes to indications on existing ARTG listings will again attract a grouping application fee of $860. If you have a listing with permitted indications but you wish to make additional changes, this can be done without charge until 5 March.

    Additional Resources:

     - CMA’s October 2020 technical alert  with information on transitioning during the final phase.

     - CMA’s January 2021 technical alert summarising the update to permitted indications in  with 3 new indications.

    - The TGA will send sponsors another reminder in the coming week.


  • 05 Feb 2021 9:43 AM | Anonymous member (Administrator)

    This Thursday, CMA and a number of key manufacturing representatives are meeting with the TGA to identify questions or issues relating to the implementation of version 14 of the PIC/S Guide to GMP (PE009, the PICS/S guide to GMP for medicinal products).

    Version 14 of the PIC/S Guide was adopted last year with a transition period, and full compliance will be expected from July 2021. As a general reminder, compliance expectations for the TGO 101 Section 16 - elemental impurities and residual solvents will also come into effect at this time.

    If members have questions, issues or problems relating to the implementation of  Version 14 PIC/S GMP, please email Lucy.Lang@cmaustralia.org.au by COB Wednesday. The process is to identify whether there is a need to modify any current TGA GMP guidance (to improve clarity) or to create any new TGA GMP guidance (if required) from an industry perspective.

    Resources:

    - Technical Alert Summary of Version 14 GMP changes

    - Current TGA interpretation and expectations for demonstrating compliance

    - Listed and Complementary medicine GMP guidance

    - TGO 101 Standard for capsules, tablets and pills


    • 02 Feb 2021 2:49 PM | Anonymous member (Administrator)

      A new Poisons Standard is in force and has been published on the Federal Register of Legislation, available here. The Poisons Standard February 2021 incorporates changes to the Poisons Standard October 2020 and also incorporates amendments to the Poisons Standard February 2021, outlined in the Poisons Standard Amendment (Boric Acid and Picramic Acid) Instrument 2021.

      Changes to the Poisons Standard of interest to the complementary medicines sector include:

      • The addition of cannabidiol (CBD) to Schedule 3 of the Poisons Standard (Pharmacist Only).

      Important points include that oral cannabidiol medicines may only be sold to a consumer by a Pharmacist. Guidance on what constitutes supply by a Pharmacist is available from State and Territory bodies, for example, NSW. The allowable maximum recommended daily dose of 150mg is higher than the 60mg initially proposed in the Scheduling consultation. However, it must first be evaluated and approved as a Registered medicine and included on the ARTG. This means it must have evidence suitable for a registered medicine. Information on applying for registered complementary medicines is available here and further information relating to over-the-counter access to low dose cannabidiol can be found here. Please also refer to CMA's 15 December member alert for the full list of Schedule 3 requirements.

      • BORON

      Boron has new requirements in Schedule 5 for warning statements that apply to the following classes of products: cosmetic hand cleaning preparations, cosmetic talc preparations, cosmetic oral hygiene preparations, and in other cosmetic preparations.

      Important Note: Boron in the 26BB Permissible Ingredients Determination- transition ending 

      While the Poisons Standard hasn’t implemented warning statements for boron for oral or dermal preparations for human therapeutic use, please be reminded that boron warning statements were introduced into the 26BB Permissible Ingredients Determination, and that these changes apply to medicines that were listed in the Register on or after 2 March 2020; or released for supply after 2 March 2021. Please refer to the Determination if you have any oral or dermal preparations with ingredients containing boron listed onto the ARTG to ensure all the warning statements are present or being implemented on batches that will be released for supply after 2 March 2021.

    • 01 Feb 2021 11:58 AM | Anonymous member (Administrator)

      Today's technical alert contains:

      - Important contextual information for members on the TGA's recently published pharmacovigilance 'FAQs', including further details of sponsor pharmacovigilance obligations; and

       - Information on the TGA issued safety advisory for Eucommia ulmoides in response to one reported allergic reaction to a product containing Eucommia.

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