The Office of Drug Control Monitoring and Compliance Section (MaCS) are seeking clarification of the nature and effectiveness of the various waste management and destruction processes employed by licence holders. This survey will inform ODC decision makers on effective waste management and destruction measures being used. The survey will be used by the ODC to develop guidance and educational materials for industry and enable the ODC to better support licence holders.
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Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the NOVEMBER 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) .
The closing date for this consultation is close of business 29 September...More
The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues:
Curcuma species and curcumin and the risk of liver injury
Green tea extract and the risk of liver injury
Safe levels of benzophenone
Clarification of the requirements for soy phosphatidylserine-enriched...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines (the Guidelines)’.
Probiotics are defined as live microorganisms that when administered in adequate amounts, are proposed to confer a health benefit on the host. The quality requirements for listed probiotic medicines are complex to piece together. The purpose of these Guidelines is to help sponsors and manufacturers meet the...More
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program.
The TGA is responsible for regulating the import, export, and supply of medical devices, including...More
Interim decision regarding lead following the discussions at the Joint meeting of ACMS-ACCS held in June 2023.
This consultation is the interim decision for LEAD (in anti-fouling paints) that was discussed at the June 2023 Joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) .
Kindly note that the interim decision in relation to lead may differ from the initial proposal. Please read through the proposed...More
The TGA is seeking feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP). By completing this survey, your response will help us to better understand any concerns with the operation of the program. Sponsors may reach out to applicable Manufacturers for help answering specific questions on audit activities if necessary, although the intent of the survey is to better understand the Sponsor interactions during MDSAP audits.
The following survey should...More
Interim decisions regarding substances discussed at the expert advisory meetings.
This consultation is for interim decisions made in relation to the other substances that were discussed at the March 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) .
Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can...More
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program.
The TGA periodically reviews requirements for medical devices to ensure they continue to be...More
This is the new version of the form: Application to amend the Poisons Standard.
Help us improve it by providing your feedback via email to the Scheduling Secretariat .
This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details.
If you are still having difficulties in completing the form, you can contact the Scheduling Secretariat via email.
All information provided must be in...More
The Therapeutic Goods Administration (TGA) is seeking public comment on potential clarification and updates to the regulation of sunscreens.
The potential regulatory clarification and updates include:
Adoption of the Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) which specifies the current testing and labelling requirements for sunscreens.
Removal of the...More
Proposed amendments to the Poisons Standard referred to advisory committees
We are consulting on applications and delegate-initiated proposals to amend the Poisons Standard. The proposed amendments and any submissions received will be considered at the June 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ACMS and Advisory Committee on Chemicals Scheduling (ACCS) in joint session (Joint ACMS-ACCS). ...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations).
Over the past two decades, rapid advances in computing...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations).
Over the past two decades, rapid advances in computing...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations).
Medical devices can include assistive technology, whether...More
Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations).
Over the past two decades, rapid advances in computing...More
The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA's proposed fees and charges for the 2023-24 financial year. Specifically, we are seeking feedback on the potential impact of the proposed fees and charges prior to seeking approval from the Government for any changes.
The TGA within the Department of Health and Aged Care is responsible for regulating...More
The Therapeutic Goods Administration (TGA) is seeking feedback on improvements to the therapeutic goods recalls process.
In Australia, recalls should be done in accordance with the procedures in our guidance document - the Uniform Recall Procedure for Therapeutic Goods (URPTG) . Performing recalls in accordance with standardised and agreed procedures is important to effectively respond to issues with therapeutic goods which may pose a risk to public health and...More
Interim decisions regarding substances discussed at the expert advisory meetings.
Please note that this consultation is for substances other than paracetamol. If you wish to comment the proposed interim decision in relation to paracetamol please see the link below:
Consultation for interim decision for paracetamol
This consultation is for interim decisions made in relation to the other substances that were discussed at the November 2022 meetings of the Advisory...More
Interim decisions regarding substances discussed at the expert advisory meetings.
Please note that this consultation is for the interim decision in relation to paracetamol only . If you wish to comment on the interim decisions for other substances discussed at the November 2022 meetings, please see the link below:
Consultation for November 2022 (other substances)
This consultation is for the interim decision in relation to paracetamol which was discussed at the ...More
On 24 December 2021 several changes to the Narcotic Drugs Act 1967 came into effect, including the introduction of a single licence model for cultivation, production and/or manufacture activities. At this time the Office of Drug Control (ODC) also implemented simpler permit processes and administrative reforms to reduce regulatory burden.
Following these reforms, the existing cost model was also reviewed, including the level at which fees and charges are set. In doing so it...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the March 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) .
The closing date for this consultation is close of business 3 February 2023. ...More
Welcome
You are now on the Australian Unique Device Identification Database ( AusUDID) Sandpit registration page.
You can return to the UDI Hub to view other AusUDID information at any time.
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The Office of Drug Control Monitoring and Compliance Section is seeking feedback on its operational performance and engagement with Medicinal Cannabis Licence holders. The medicinal cannabis industry’s feedback will help the Monitoring and Compliance Section meet stakeholders expectations in accordance with best practice regulation.
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The Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia.
The potential reforms are aimed at preventing children and adolescents from accessing NVPs, while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription.
We are seeking public comment on whether you support potential reforms in 4 main areas:...More
The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of International harmonisation of ingredient names (IHIN) .
We are seeking feedback on:
whether health professionals, consumers and health systems are ready for dual labelling to end...More
From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to the TGA.
The purpose of this survey is to seek your feedback on the new application form.
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Scheduling amendments referred to expert advisory committee
Please note that there is a separate consultation for interim decisions relating to PSILOCYBINE and MDMA which can be found by clicking the link below:
Psilocybine and MDMA consultation
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the June 2022 meetings of the Advisory Committee on...More
Scheduling amendments referred to expert advisory committee
Please note: this is a consultation for the interim decisions relating to PSILOCYBINE and MDMA ONLY. If you wish to provide comments on the other items considered at the ACMS and ACCS meetings in June 2022, please visit the alternate consultation hub by clicking the link below:
Consultation for other substances considered in June 2022
This consultation is for interim decisions made in relation to Psilocybine...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals ’ .
The purpose of this draft guidance is to assist sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices. The draft guidance aims to provide clarity on which regulatory pathway is...More