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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.

  • 04 Dec 2020 3:30 PM | Anonymous member (Administrator)

    The Minister for Industry, Science and Technology, the Hon Karen Andrews MP, today has opened the second round of the Manufacturing Modernisation Fund (MMF2). This is the first program to open under the $1.5 billion Modern Manufacturing Strategy which will assist Australian manufacturers to scale-up, improve their competitiveness and build resilient supply chains.

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

    Subscribe for updates on the Strategy by completing the linked form on the Department of Industry, Science, Energy and Resources website

  • 02 Dec 2020 12:51 PM | Anonymous member (Administrator)

    Following the August 2020 consultation on Low-negligible risk changes to Permissible Ingredients- 2020-2021, the TGA have published the outcomes on their website for Easily dissociable magnesium salts and Andrographis paniculata.

    CMA are pleased to note that the changes to the original consultation proposal for magnesium salts are more aligned to the evidence base and consumer use profiles of these products and therefore, the warning statements will be less restrictive and apply to a lower number of existing products, helping consumers better identify those products that are more or less likely to have a gastrointestinal effect.

    Sponsors of Andrographis products need to be aware that a new statement relating to taste disturbances will be introduced.

    The changes to the Permissible Ingredients determination will commence on 1 March 2021 for new listings. Sponsors will be provided a 12- month transition period, until March 2022, to make the necessary changes for existing medicines. Please also see the alert for expected changes to how transition dates are implemented which will be clearer and easier to implement for industry.

    Please read today's technical alert for more information on these changes.

  • 01 Dec 2020 8:48 AM | Anonymous member (Administrator)

    CMA are pleased to inform members of the registration of the Therapeutic Goods (Standard for Tablets, Capsules and Pills) Amendment Order 2020, which provides a three-month extension to the requirements for elemental impurities and residual solvents in Section 16 of the TGO 101, from 31 March 2021 to the new commencement date of 30 June 2021.

    More details on the above, as well as contextual information for sponsors on capsule and tablet size (due to member enquiries), can be found in today's technical alert.

  • 30 Nov 2020 8:26 AM | Anonymous member (Administrator)

    CMA is providing information for members to note, that it is expected there will be changes to the Permissible Ingredients Determination in 2021 to better streamline requirements and ease unnecessary burden.

    These changes are expected to be implemented in the first quarter of 2021 if there are no further changes made through consultation. As a targeted industry-only consultation, member feedback on those changes to CMA is welcome until 5pm 14 January 2021. Please read the full technical alert for more information.

  • 25 Nov 2020 10:57 AM | Anonymous member (Administrator)

    The TGA are implementing an update to ARTG summaries for listed medicines for both sponsors and the public. 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. 

    The changes are set to be implemented over the next few weeks are likely to be released by the end of December. Please read today's member alert for more information.

  • 18 Nov 2020 3:00 PM | Anonymous member (Administrator)

    As part of the wider reform agenda for the food regulatory system the Department of health is conducting a consultation on Consistency of Food Regulatory Approaches

    Stakeholder advice is being sought on areas of inconsistency in food regulation and the impacts of this on businesses and regulatory outcomes, including adverse regulatory outcomes and/or creating adverse outcomes for food businesses. Stakeholder advice is also sought on areas of duplication between the food regulatory system and related regulatory systems, such as therapeutic goods.

    Responses to the consultation, which closes on 18 December 2020can be submitted via an online survey.

    Please read the full technical alert for more details.

  • 18 Nov 2020 12:01 PM | Anonymous member (Administrator)

    Members often seek information on clarification around GMP considerations for for active ingredients or processed materials that are used in the manufacture of complementary medicines. Today’s technical alert provides recent clarifying information relevant to those considerations. Please read the full alert for more details.

  • 11 Nov 2020 4:23 PM | Anonymous member (Administrator)

    Today's technical alert provides important information on a technical item for sponsors, consultants and manufacturers to be aware of.

    CMA encourages members to read the alert and to share the information with relevant members throughout your individual organisation.

  • 10 Nov 2020 11:48 AM | Anonymous member (Administrator)

    Today's technical alert includes important information for sponsors in relation to mandatory pharmacovigilance requirements and best practice TGA expectations. 

    Our member only alert, available here via member login, includes all of the information contained in the public alert below, in addition to other information tailored specifically to help members reduce regulatory burden and other member only information.

    The public alert is available for open distribution to all members of industry to ensure that all have access to timely reminders for minimum compliance requirements which help to uphold industry safety and quality. This public link can be shared.

  • 29 Oct 2020 9:21 AM | Anonymous member (Administrator)

    The Government has acknowledged that Australian manufacturers face a challenging business environment due to the COVID-19 pandemic, and by working with industry, aims to create a competitive business environment, build scale and boost supply chain resistance. Announcement of a $1.5 billion investment in a Modern Manufacturing Strategy has been made, with funding available for eligible manufacturers for key manufacturing initiatives.

    For more details on the Strategy and eligibility criteria, please read today’s member alert. 

    Subscribe for updates on the Strategy by completing the linked form on the Department of Industry, Science, energy and Resources website.

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