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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 Apr 2022 11:49 AM | Anonymous member (Administrator)

    This member only Technical alert outlines TGA mandatory pharmacovigilance requirements. Not conforming to mandatory pharmacovigilance requirements places members at risk of regulatory action, including infringements, and the TGA have given infringements to some in 2021 and 2022 for not complying with these requirements. 

    This technical alert also describes best practice pharmacovigilance for practices which might be considered at a TGA inspection of a sponsor as part of the Pharmacovigilance Inspection Program.

    This information was disseminated to members in November 2020 and in May 2021.

    In addition to the member only alert, a public alert is available for open distribution to all members of industry which describes the mandatory requirements to ensure that all have access to timely reminders for minimum safety compliance requirements which help to uphold industry safety and quality. This public link can be shared.

  • 04 Apr 2022 11:06 AM | Anonymous member (Administrator)

    A new Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022 will commence Friday 22 April 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. 

    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. Suppliers need to ensure they are providing up-to-date and relevant information to sponsors/manufacturers so 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 when there are changes to ingredients or requirements that may affect compliance).

  • 29 Mar 2022 11:02 AM | Anonymous member (Administrator)

    This technical alert provides key points for member consideration when responding to the Evidence Guidelines consultation closing this Friday 1 April 2022.

    Information about an extension until Friday 15 April for flood or disaster affected stakeholders is also included CMA encourages all members to submit a response to the Evidence Guidelines. consultation.

    CMA encourages all members to submit a response to the Evidence Guidelines consultation.

  • 04 Mar 2022 12:50 PM | Anonymous member (Administrator)

    The Public Consultation on the draft Evidence Guidelines for listed medicines has been published. 

    A consultation period of 4 weeks has been provided, closing 1 April 2022.

    This technical alert provides preliminary information on the consultation for members. Please note, CMA are currently reviewing the consultation paper and intend to provide a deeper analysis on the draft guidelines in the coming days, including advice for members on how to respond to the consultation.

  • 23 Feb 2022 9:18 AM | Anonymous member (Administrator)

    A new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2022 will commence on 1 March 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 ingredients

    - 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. Suppliers need to ensure they are providing up-to-date and relevant information to sponsors/manufacturers so 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 when there are changes to ingredients or requirements that may affect compliance).

  • 15 Feb 2022 10:12 AM | Anonymous member (Administrator)

    Reminder: Pharmacovigilance Survey for Sponsors closing this Friday 18 Feb 2022.

    The TGA is seeking feedback to help inform them how to best tailor what data sponsors would like to view or extract as part of the TGA's Medicines Adverse Data Exchange project, which seeks to improve the management of medicines safety signals by improving how the TGA share medicine adverse events data and making it easier for health professionals to report adverse events.

    CMA have asked TGA for better and easier access to data for listed medicines to make PV obligations easier. This is your opportunity to have your say directly on outcomes.

    The consultation proposes to implement new functionality that allows sponsors to view and export documents with de-identified medicine adverse event data from TGA systems using existing sponsor authentication. Feedback is sought, e.g.:

    - 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 systems.

    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.

    Reminder: European Guidelines Survey closing this Sunday 20 Feb 2022.

    The TGA is seeking feedback on whether or not certain international scientific guidelines should be adopted. While they are generally not mandated by legislation (unless included in a standard), the TGA refer to them during pre-market applications for medicines, which can include Registered complementary and Listed Assessed medicine applications. During an application, deviation from a guideline must be justified by the sponsor.

    The following proposed guidelines may be of relevance to complementary medicine applications. Respondents to the https://consultations.tga.gov.au/tga/proposed-adoption-of-international-scientific-guid/survey are given the option of supporting, or not supporting and reasons why.

    - ICH guideline Q3C (R6) on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006)

    - ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals (EMA/CHMP/ICH/544278/1998)

    - Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease (CPMP/EWP/553/95 Rev. 2)

    - Guideline on the clinical development of medicinal products intended for the treatment of pain (EMA/CHMP/970057/2011)

    - Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action (EMA/CHMP/CVMP/QWP/336031/2017)

    - Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012)       

    - Questions and answers on implementation of risk-based prevention of cross contamination in production and Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/246844/2018)

    - ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management (EMA/CHMP/ICH/804273/2017)

    - Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container

    CMA would like to hear from members on how you perceive these pharmacovigilance or EU guidelines proposals will affect the complementary medicines industry and any constructive suggestions. Please contact Lucy.Lang@cmaustralia.org.au

  • 04 Feb 2022 10:07 AM | Anonymous member (Administrator)

    This technical alert provides members with a summary of 2021 TGA activities and outcomes in relation to complementary and over the counter (OTC) medicines. This information is provided by TGA to CMA as part of CMA's ongoing engagement activities with the TGA.

    Further information on upcoming TGA activities, reviews and reforms forecast for 2022 are provided.

    Please read the full alert for more information.

  • 01 Feb 2022 10:52 AM | Anonymous member (Administrator)

    The TGA is conducting a public consultation on the TGA's proposed increase to fees and charges for the 2022-23 financial year by an indexation factor of 2.60%.

    This technical alert provides information on the TGA Fees and Charges Proposal 2022-23, including on a proposal to apply new fees for variations on Clinical Trial Approval (CTA) schemes.

    The TGA have expressed a preference for consolidated feedback from your industry body (CMA). Members are asked to provide any feedback to the consultation to CMA by  Mon 238 Feb 2022 via technical@cmasutralia.org.au

  • 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.

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