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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.

  • 03 Aug 2023 2:34 PM | Anonymous member (Administrator)

    The TGA have published the annual public consultation for proposed ingredient changes to the Therapeutic Goods (Permissible Ingredients) Determination (‘the Determination’) for issues considered lower to negligible risk, open from today, Thursday 3 August 2023 to 23:59 AEST Thursday 14 September 2023.

    Ingredients under review include:

    1. Curcuma species and curcumin and the risk of liver injury
    2. Green Tea (Extract) and the risk of liver injury
    3. Benzophenone carcinogenicity concerns, proposed to be restricted to topical use at a maximum of 26ppm
    4. Clarification of the requirements for soy phosphatidylserine enriched ingredients, including proposed 300mg MRDD
    5. Clarification of the requirements for Terminalia ferdinaniana (Kakadu Plum)

    Please read today’s full alert for more information, background and details.

  • 02 Aug 2023 10:46 AM | Anonymous member (Administrator)

    The TGA has made changes to  pharmacovigilance expectations for sponsors following consultation on Proposed changes to Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements.

    There will be a 6-month implementation period, beginning Tuesday 1 August 2023, and concluding on Wednesday 31 January 2024during which adoption of the changes included in the updated guidelines  are strongly encouraged, but not mandatory and will not be inspected against. Sponsors are encouraged to review the new guidance closely to ensure pharmacovigilance systems become aligned with the new system.

    This technical alert provides more information for members, including a summary of consultation outcomes, a comparison between the previous and new Pharmacovigilance guidance, and details of a series of upcoming TGA webinars, which will outline and explain the changes to the Pharmacovigilance Guidelines.

  • 31 Jul 2023 3:47 PM | Anonymous member (Administrator)

    The TGA implemented the Good Clinical Practice (GCP) Inspection Program in 2022 and have recently published the first report on the program covering July -December 2022.

    The TGA are now conducting a webinar on Insights from the TGA Good Clinical Practice (GCP) Inspection Program and will be running the same webinar twice to increase the ability for stakeholders to attend.

    In this webinar, TGA presenters Tahli Fenner and Anastasia Makshakova will provide:

    - an overview of the GCP inspection program

    - insights from the first year of the program.

    This information may be of interest to Research and academic institutions conducting clinical trials and Sponsors and other members sponsoring or involved in clinical trials, or considering entering the AUST LA pathway.

    Session 1

    When: Monday 7 August 2023

    Where: Online

    Time: 4-5 pm AEST 

    Register HERE


    Session 2

    When: Wednesday 9 August 2023

    Where: Online

    Time: 12-1pm AEST 

    Register HERE

    More information on the GCP Inspection Program is available on the TGA website.

  • 31 Jul 2023 1:43 PM | Anonymous member (Administrator)

    FSANZ has announced a consultation on Standard 2.9.4 – Formulated Supplementary Sports Foods (FSSF) of the Australia New Zealand Food Standards Code, closing Monday 4 September 2023The consultation scope is on the regulation of nutrition content and health claims for sports foods.

    FSANZ is gathering stakeholder views through this consultation, before developing specific proposed changes to the Standard 2.9.4, which will then be subject to a 1st statutory Call for Submissions (public consultation).

    CMA recommends that it will be most effective for members express their views in the current consultation in order to shape the future development of the Standard. Please click the above link for more information.

    Please read the full alert here

  • 31 Jul 2023 1:24 PM | Anonymous member (Administrator)

    Following the correct TGA recalls process: Examples

    In October 2019 the TGA released a recalls online form through the TGA's eBusiness service (eBS) Portal.

    Due to the pandemic, the TGA still accepted some email notifications on a case-by-case basis until June 2023. However, the TGA now wish all recall actions and notifications to be submitted via the online form. This Technical alert covers information about using the form expected by the TGA under current circumstances. 

    NOTE: Earlier this year the TGA sought submissions from the public on potential changes to how product recalls are taken in Australia. The outcomes of this consultation are yet to be published and implemented. Published submissions are available here. The Government will consider all submissions prior to making decisions to the URPTG. The online form will remain in place, however changes to the form may be made in the future. In the interim, existing processes and the online form must be followed.

    Sponsors are asked to be aware of the following in regards to the online form:  

    - As of 1 July 2023, the TGA expect all recall actions to be via the eBS Portal’s online recall submission form (unless TGA have given an exception for genuinely urgent circumstances).

    - Sponsors who continue to submit actions via email without a sufficient reason will be directed to submit the information via the eBS Portal within 24 hours. If this does not occur, the TGA will process this as a 'Recall Not Following the URPTG' published in the SARA database and notified to State and Territory authorities. 

    - Some submissions being left incomplete or providing inadequate information are resulting in delays. Mandatory fields are expected to have the correct information included in the field (not terms such as ‘see attached document’). All relevant fields should be completed. 

    E.g., the Problem Description field should plainly and succinctly summarise the problem; and the Product Description should include all relevant identifiers, including the product name, ARTG number, any model/batch/lot/code number(s) and expiry date(s) as applicable.

    - Key documents for a recall action i.e. draft customer letter, distribution/customer list and the health risk/hazard assessment, must be included with your submission. If any information is not available at the time of submission, please notify recalls@health.gov.au as soon as possible. 

    - Customer lists: There has been some inadequate attention to detail and some significant variations occurring within the same company e.g., suburb information not provided, suburbs and customers incorrectly matched, suburbs and/or customers in the wrong State or Territory, irrelevant details such as customer ABN and account numbers. The correct content and format for customer lists are shown on page 22 of the URPTG and must be submitted in MS Xcel format using the attached template.

    Example documents to assist members:

    Examples of the required information for each field of your online submissions, and how this information will eventually be published in the SARA database:

    2023 Example of filling out a TGA Online Recall Submission Form (PDF)

    Example of an invented customer list, with a range of guidance information included:

    2023 Example of a Customer List with guidance information (XLXS)

    Improvement in the quality of submissions will assist TGA assessing and agreeing to market action in a shorter time.

    In the event of a system issue with the online form, please contact the TBS Helpdesk on 1800 010 624, or by email at ebs@health.gov.au.

    Other resources:

    TGA Website: Submitting recall information  

    TGA Presentation: New Online Web Form for submitting Recall and Non-Recall actions

    A printable version of this alert is available here.

  • 24 Jul 2023 10:53 AM | Anonymous member (Administrator)

    The TGA has announced a public consultation on the proposed New Guidelines for the Quality of Listed Probiotic Medicines. It applies to quality expectations for finished products that are listed or assessed listed medicines [AUST L or AUST LA].

    The consultation is open from today, 24 July 2023, until Sunday 10 September 2023.As a public consultation, the TGA will receive comments from any person or group. We encourage your feedback to also be submitted to CMA

    - Members are urged to review the proposed guidelines to determine if any aspects cause a concern for your business.

    The stated purpose of the Guidelines is to:

    - help sponsors and manufacturers meet the regulatory requirements to ensure the quality of their probiotic medicine is acceptable under the Therapeutic Goods Act 1989 (the Act); and

    - assist with sponsor and manufacturer compliance by naming and explaining the most relevant applicable legislation related to ensuring the quality of probiotic medicines.

    Please read today's full technical alert for more information, including relevant background, transition information, consultation questions and details on how to respond to the consultation.

  • 23 Jun 2023 2:44 PM | Anonymous member (Administrator)

    This Technical Alert contains all details of new, deleted and changed ingredients, and a comparison table of all changes to the Determination for members. Please note that the information in this alert is included in a comparison table and is more detailed than the description published on the TGA website.

    This alert details:

    NEW ingredients

    The addition of the following new ingredients for use in listed and assessed listed medicines.

    - Addition of the new ingredient, refined Buglossoides arvensis seed oil, for use in listed and assessed listed medicines, with exclusive use provisions for 2 years;

    - Addition of the new ingredient, chicken sternum cartilage powder, for use in listed and assessed listed medicines, with exclusive use provisions for 2 years;

    CHANGED ingredients 

    - Correction of a minor typographical error in the wording of the restriction for the ingredient, violet leaf absolute, in relation to its use as a fragrance;

    - Correction of the spelling for the ingredient “Saccharomyces cervisiae polysaccharides” to “Saccharomyces cerevisiae polysaccharides”; and

    REMOVED  ingredients 

    - Resolution of the duplicate ingredients, “Poloxamine” and “Poloxamine 1301”, into a single entry, “Poloxamine”.

  • 22 Jun 2023 12:34 PM | Anonymous member (Administrator)

    Today's tech alert provides members with an interim update on the taxonomic name changes to Lactobacillus spp. and additional information, including:

    - Update on future consultation for any mandatory name change for therapeutic goods;

    - Potential options if sponsors wish to provide voluntary, additional information about changed names on labels for products containing Lactobacillus spp.; and

    - A comparison list of Lactobacillus species on the ARTG with name changes according to Lactotox and EFSA.

  • 19 Jun 2023 2:46 PM | Anonymous member (Administrator)

    As part of FSANZ's caffeine review (P1056), FSANZ are seeking additional feedback on caffeine containing Formulated Supplementary Sports Foods (FSSF) to inform a Consultation Regulatory Impact Statement (CRIS) should it be determined that one is required. 

    Members are asked to provide in-confidence feedback to CMA, via technical@cmaustralia.org.auby C.O.B. Friday 30 June, on the potential economic impacts of the proposed changes on affected products. Please read the full alert  for more details and information.

  • 05 Jun 2023 10:53 AM | Anonymous member (Administrator)

    Please read today's full member alert for details on:

    - Upcoming TGA annual charge deadlines for Sponsors and    Manufacturers, including key dates for:

    - requests for cancellation of goods from the ARTG;

    - requests for revocation of manufacturing licences;

    - submitting turnover declarations; 

    - due dates for payment of annual charge invoices for active ARTG   entries and manufacturing licences; and 

    - The end of the transition period for certain sports supplements (presented in the form of tablets, capsules or pills) on 29 November 2023, including additional information for sponsors, manufacturer, retailer and advertiser consideration. 

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