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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.

  • 19 Jan 2022 12:38 PM | Anonymous member (Administrator)

    The TGA is seeking feedback from sponsors, via an online survey, on a proposal  to improve sponsor access to extract de-identified medicine adverse event data to support their pharmacovigilance (PV) obligations. Your feedback to the survey will help inform the TGA how to best tailor what data sponsors would like to view or extract.

    The Sponsor survey is open now, closing on 18 February 2022.

    This survey is part of the TGA’s Medicines Adverse Event Data Exchange project, which seeks to improve the management of medicines safety signals by:

     - improving how TGA share medicine adverse event data held in TGA systems with sponsors, jurisdictions and the public; and

     - making it easier for health professionals to report adverse events to the TGA.

    About the Survey

    There is currently no ability for sponsors to automatically view or export de-identified adverse event data held in TGA systems, which is needed as part of sponsor PV responsibilities. Instead, currently sponsors seek data by manually searching the public DAEN, and via email requests to the TGA, which is inefficient and causes delays.

    This consultation proposes to implement new functionality that allows sponsors to view and export documents with relevant de-identified medicine adverse event data from TGA systems using existing sponsor authentication. They are seeking sponsors’ feedback on:

     - What medicine adverse event data sponsors wish to view and/or extract from TGA’s Adverse Events Management System.

     - The preferred format(s) for the extracted data to support its upload into sponsor OV systems.

     - Sponsors’ ability to transition to use the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Enterprise to Business (E2B) R3 standard for submitting and receiving adverse event reports via the secure Electronic Data Interchange service.

    Start the survey here and view the consultation page here.

    Some of the survey questions require some thought and team discussion - information and survey questions can be accessed prior to starting the survey at this consultation document.

    CMA would like to hear from members on how you perceive these proposals will help or hinder the complementary medicine industry and any concerns or constructive suggestions relating to the industry level. please contact Lucy.Lang@cmaustralia.org.auLucy.Lang@cmasutralia.org.au with feedback.

  • 19 Jan 2022 11:22 AM | Anonymous member (Administrator)

    This technical alert provides an important update to sponsors on recently published data about particular herbal materials and includes further details for sponsors to be aware of.

    Please read the full technical alert for more information.

  • 19 Jan 2022 8:58 AM | Anonymous member (Administrator)

    The TGA will be conducting targeted compliance reviews of selected listed medicines that contain ingredients which require warning statements related to use during pregnancy from the Permissible Ingredients Determination or the Poisons Standard.

    This technical alert provides more details and additional information for members to be aware of including affected ingredients from the Permissible Ingredients Determination.

  • 18 Jan 2022 1:46 PM | Anonymous member (Administrator)

    A new Therapeutic Goods (Permissible Ingredients) Determination (No.1) 2022 will commence on 24 January 2022.

    This Technical Alert includes a list of changes for sponsors, manufacturers and raw material suppliers to use to assist in identifying the changes to the Determination. Please note that this alert contains more detailed and specific comparative information about the changes than the summary published on the TGA webpage.

    This alert details:

     - NEW ingredients and specific requirements that apply to that ingredient

     - CHANGED ingredients with the original requirements and the new or changed requirements.

     - DELETED ingredients if applicable

    For ingredients that have changed:

     - Sponsors should review affected products for changes to compliance requirements (this may include increased or decreased regulatory requirements).

     - Suppliers of raw materials, especially proprietary ingredients, should also ensure that changes to ingredients are checked against materials that they provide to sponsors and manufacturers. Suppliers need to ensure they are providing up-to-date and relevant information to sponsors/manufacturers so that they can remain in compliance with their legal obligations under the Therapeutic Goods Act 1989. The TGA expect sponsors to obtain correct information from suppliers to meet obligations, and for suppliers to provide the necessary and correct information to sponsors (including contacting sponsors if there are changes to requirements that may affect ingredient or product compliance.

  • 17 Jan 2022 11:39 AM | Anonymous member (Administrator)

    Today's important member alert contains important information for members, including sponsors, manufacturers, retailers and practitioners, in relation to the TGA's decision not to amend the Poisons Standard for amygdalin and hydrocyanic acid.

    Whilst amygdalin for therapeutic use has been prohibited via Scheduling for many years, it can be a substance found in low or trace amounts in a range of foods and herbal medicines from the Prunus (such as almond, cherry) and Malus (apple) species

    Members are strongly encouraged to read today’s full alert for further details, context and possible impacts. Today's alert also includes a timeline summarising the Scheduling history of amygdalin.

  • 13 Jan 2022 8:45 AM | Anonymous member (Administrator)

    Members are reminded that the end of the transition period for existing products that contain inorganic magnesium salts and Andrographis is 28 Feb 2022. Sponsors have been provided a 12-month transition period from 1 March 2021 to bring existing listed medicine products into compliance:

     - Existing products that contain Andrographis must include a taste disturbance warning from March 1 2022.

     - Existing products that contain inorganic magnesium salts must include a laxative warning on labels from 1 March 2022 when the magnesium meets the requirements of the Permissible Ingredients Determination.

    Please read today’s technical alert for more details.

  • 06 Jan 2022 10:40 AM | Anonymous member (Administrator)

    Please read today's tech alert for further information on:

     - Titanium dioxide (TiO2) - Europe update;

     - Proposed amendments to the Poisons Standard: Cannabis and       tetrahydrocannabinols; 

     - Medicines Advisory Statements Specification (MASS) updates for   registered medicines - menthol, methyl salicylate, melatonin; and 

     - TGA stakeholder survey report 2021.

  • 06 Jan 2022 10:16 AM | Anonymous member (Administrator)

    The TGA have published new Guidance on applying the new Advertising Code rules. The new Advertising Code (2021) took effect on 1 January 2022 and is subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply.

    Please read today’s Member Alert for more details, including information on mandatory statements, testimonials and endorsements, health warnings and how to register for the upcoming TGA Advertising Code webinar on Thursday, 20 January 2022. 

  • 17 Dec 2021 12:09 PM | Anonymous member (Administrator)

    The TGA have published outcomes of the consultation on proposed low-negligible risk changes to the Permissible Ingredients Determination, which occurred in August-September 2021. These changes include amendments to:

     - Vitamin B6 containing products

     - Artemisinin containing products

     - Allergen statement for mollusc-derived ingredients

    The final changes will commence on 1 March 2022, after which new (or newly ‘grouped’) medicines that are released for supply are generally expected to be compliant with new requirements.

    For existing medicines, a one-year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2023

    Please read today’s Tech Alert for more information and details.

  • 03 Dec 2021 8:29 AM | Anonymous member (Administrator)

    The TGA have published a new Advertising Code (2021) from commencement on 1 January 2022 with a 6 month transition period ending on 30 June 2022.

    The Therapeutic Goods (Therapeutic Goods advertising Code) Instrument 2021 has been made under section 42BAA of the Therapeutic Goods Act 1989 commencing 1 January 2022 and repeals the Therapeutic Goods Advertising Code (No. 2) 2018

    NOTE: Despite the repeal of the former 2018 Advertising Code, it will continue to apply for the duration of the 6-month transition period, such that requirements specified in the former code may continue to be complied with during transition.

    Please read today’s full member alert for further information and details on changes to the Code, including a table of comparative changes on warnings statements.

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