CMA welcomes comments on the following open consultations and reviews:
The NHMRC research funding program and calendar is available on the NHMRC website here.
Review of the Modern Slavery Act 2018
Closed 22 November 2022
The Modern Slavery Act 2018 (Cth) commenced on 1 January 2019 and complements Australia’s comprehensive criminal justice response to modern slavery.
The Act was established through extensive consultations with the Australian business community and civil society. Under the Act, large businesses and other entities operating in Australia must report annually on how they are addressing modern slavery risks in their domestic and global operations and supply chains.
The Australian Government is undertaking a statutory review of the Act’s operation and compliance over the first three years since commencement. The review commenced on 31 March 2022 and is to be completed within one year, followed by a report to be tabled in Parliament. Professor John McMillan, AO, is leading the review, supported by the Attorney-General’s Department.
House of Representatives Standing Committee on Health, Aged Care and Sport: Inquiry into long COVID and repeated COVID infections
Closed 18 November 2022
The House of Representatives Standing Committee on Health, Aged Care and Sport is conducting an inquiry into Long COVID and Repeated COVID Infections.
Respondents are invited to make a submission relevant to the inquiry’s terms of reference.
Draft Australian Standard for squalene and shark liver oil
Closed 4 November 2022
The objective of the draft standard* is to specify requirements for sustainable sourcing and testing and analysis of squalene and shark liver oil quality. It also provides requirements for packaging and labelling of derivative products containing these oils, especially when accompanied by claims of provenance.
*Please note: Australian Standards are voluntary. They do not include contractual, legal or statutory requirements. This standard does not replace the provisions of the Australian Fisheries Management Authority, FSANZ, TGA or applicable Commonwealth, State and Territory laws and regulations.
Department of Health Food Regulation: Horizon scan to support the System Strategic Direction for 2023-2026
Closed 7 August 2022
The Australia New Zealand Food Regulatory System (the System) is currently undergoing its most significant reform and modernisation effort since its inception in the 2000s.In December 2021, Food Ministers agreed to key actions to progress the reform agenda. One of the agreed actions was to develop and deploy a new strategic planning process that would support a regular reset of the System’s strategic direction. It was agreed that this would be done via a new, more inclusive and transparent way. The development of this ‘Horizon Scan’ is the first step in this new planning process. The Horizon Scan takes a broad view of the wide food system challenges and opportunities.
Productivity Commission review of Australia's productivity performance
Closing 23 March 2022
The Productivity Commission has been asked to review Australia's productivity performance and recommend an actionable roadmap to assist governments to make productivity-enhancing reforms.
Prime Minister and Cabinet Consultation on legislation to lift regulator performance
Closed 14 January 2022
The Government is seeking feedback on legislation aimed to lift regulator performance, capability and culture as part of Australia’s Deregulation Agenda. The draft of the Bill includes 46 amendments across 17 Commonwealth Acts that will improve or streamline administrative processes, remove provisions that serve no current purpose, or remove legal uncertainty.
Senate enquiry into the Australian Manufacturing Industry
Closed 10 September 2021
On 12 August 2021, the Senate referred the matter of the Australian manufacturing industry to the Economics References Committee for inquiry and report by 24 November 2021. The Terms of Reference outline the areas of inquiry. CMA will be making a submission to the enquiry and encourages members to also provide a response with regard to the information provided on accepted submissions and the enquiry’s terms of reference.
ACCC -Digital Platform Services Inquiry – Report on general online retail marketplaces
Closed 19 August 2021
The Australian Competition and Consumer Commission (ACCC) is examining general online retail marketplaces as part of the Australian Government’s direction to the ACCC for a five year inquiry into digital platform services (the Inquiry), which includes electronic marketplace services. To address concerns that have been raised to the ACCC about the conduct of some marketplaces and the risk of harm to both sellers and consumers, the ACCC is seeking stakeholder views on potential competition and consumer issues in the provision of general online retail marketplaces to consumers in Australia, including consumers, small business customers, sellers and the marketplaces themselves.
The Treasury -Patent Box Consultation Closed 16 August 2021
The Australian Government announced that it will introduce a ‘patent box’ for eligible corporate income associated with new patents in the medical and biotechnology sectors. ‘Patent box’ is a generic term for regimes that apply a concessional tax treatment to profits derived from eligible intellectual property (IP). The patent box relates to eligible revenue derived from inventions that would fall within the scope of Australian standard patents (including where the invention is protected by foreign patents) and will apply to companies for income years commencing on or after 1 July 2022.
Department of Health - review of the FSANZ Act 1991- Draft Regulatory Impact Statement
Closed 18 May 2021
As part of the review of the Food Regulation System, the Department of Health have opened a consultation to seek stakeholder feedback on the Review of the Food Standards Australia New Zealand Act 1991 (the Act) - draft Regulatory Impact Statement (RIS), and to provide feedback to characterise the impact of the proposed options within the RIS.
The draft RIS identifies three policy problems at the core of the outdated legislative scheme in which the effectiveness of regulation is diminishing, and provides three options to address the policy problems.
This consultation represents the potential for significant change within the food regulatory system, as the Act has been in place for almost 30 years, with few amendments over that time. The data, commentary and information received through this consultation will be analysed to inform a final Regulatory Impact Statement, which will be used to inform any amendments to the FSANZ Act.
NHMRC Dietary Guidelines Review: Scoping Survey
Closed 3pm (AEDT) 15 March 2021
The NHMRC are conducting a Review of the 2013 Australian Dietary Guidelines, a multiphase process with the final step resulting in publication of updated Dietary guidelines in 2024. The current Guidelines make community recommendations on dietary sources and approaches to nutrients. As part of the Review process, NHMRC will consider how the current Guidelines are used and who is using them.
Feedback from stakeholders, including those involved in product research and development, manufacturing and marketing is sought via a scoping survey, available on the NHMRC website, which asks stakeholders how they use the guidelines and which topics should be considered in the review to identify relevant topics which may include topics not included in the current Guidelines or an update to existing topics.
Following the conclusion of the scoping survey, the NHMRC will establish an Expert Committee to provide advice.
For more information on the Review, including expected timelines for the review process, please visit the NHMRC website.
Evaluation of current Country of Origin Labelling regulations for food
Closed 4 January 2021
The Department of Industry, Science, Energy and Resources (DISER) has commissioned Deloitte Access Economics to undertake an evaluation of current Country of Origin Labelling regulations for food.
The reforms introduced a standard labelling scheme to display key information to consumers about the location of production and the proportion of the food’s Australian content.
As part of the evaluation, the Department is undertaking a survey of businesses and industry stakeholders to analyse industry experience with the regulations.
ASPIRATIONS FOR THE FOOD REGULATORY SYSTEM
Closed 22 Jan 2021
This consultation forms part of the broader consultations on the reform of the food regulatory system. It addresses the first stage of the Review of the Intergovernmental Food Regulation Agreement project, but will also inform the collaborative food regulatory system reform work more broadly. The consultation paper broadly describes some of the challenges and opportunities facing the food regulatory system over the next 20 years, sets out the objectives and scope of the collaborative Australia and New Zealand food regulatory system and proposes a set of aspirations for the food regulatory system and some associated high level actions on which stakeholder comment is sought.
Feedback can be provided via online consultation available on the Department of Health's Consultation hub.
CONSISTENCY OF FOOD REGULATROY APPROACHES
Closed 18 December 2020
In March 2020, the Australian New Zealand Forum on Food Regulation (the Forum) endorsed an implementation plan for an ambitious reform agenda for the food regulatory system aimed at ensuring the system remains strong, robust and agile into the future. The reform agenda is being progressed through a number of interconnected projects. The outcomes of each of the consultation processes will be drawn together to inform decisions of the FRSC and the Forum in relation to the future of the food regulatory system. This consultation process seeks stakeholder advice on areas of inconsistency in food regulation and the impacts of this on businesses and regulatory outcomes. Impacts might include 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.
Feedback can be provided via online consultation available on the Department of Health's Consultation hub.
MODERN MANUFACTURING STRATEGY
Closed 9 November 2020
The Department of Industry, Science, Energy and Resources is seeking feedback on the key strengths, opportunities and solutions to grow manufacturing in the identified National Manufacturing Priority areas, including foods and medicinal products. 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 resilience. Announcement of a $1.5 billion investment in a Modern Manufacturing Strategy has been made, with funding for eligible manufacturers for key manufacturing initiatives
Feedback can be provided by a survey which is available on the Department's website.
NATURAL THERAPIES REVIEW-TRANCHE 2
Closed 23 October 2020
The Department of Health has now opened a public invitation to submit evidence for Tranche 2 natural therapies. The consultation and evidence requirements are now available through the Department's Consultation Hub.
NATIONAL PREVENTATIVE HEALTH STRATEGY
Closed 28 September 2020
The Department of Health's Strategy will provide the overarching, long-term approach to prevention in Australia by building systemic change to ensure the best outcomes for all Australians. The Strategy will identify areas of focus for the next 10 years and outlines evidence-based approaches to underpin future priorities.
The Strategy will aim to help Australians improve their health at all stages of life, through early intervention, better information, and targeting risk factors and the broader causes of health and wellbeing.
The Strategy will recognise that health is not just the presence or absence of disease or injury – more holistically, it is a state of wellbeing. The Strategy will not be disease specific in its approach but rather, it will focus on system wide, evidence-based approaches to reducing poor health.
COUNTRY OF ORIGIN LABELLING FOR COMPLEMENTARY MEDICINES: PROPOSED INFORMATION STANDARD
Closed 24 September 2020
The Australian Government is developing an Information Standard for complementary medicine manufacturers and sponsors seeking to make ‘Made in Australia’ claims. Products making a claim in line with the 2020 reforms will be required to disclose the proportion of Australian ingredients on labels when the product is claimed to be ‘Made in Australia'. The proposed Information Standard is expected to be similar to the Country of Origin Food Labelling Information Standard 2016. Currently it is voluntary for the complementary medicines sector to make Australian origin claims, however they are subject to the same CoOL laws.
PREGNANCY CARE GUIDELINES
Closed 17 July 2020
The Department of Health has opened a public consultation of the 2nd staged review of the pregnancy care guidelines- Nutrition, Physical Activity and Weight. The guidelines are designed to support Australian maternity services to provide high-quality care to healthy pregnant women, and are intended for all health professionals who contribute to antenatal care.
Following consultation, the draft Guidelines will be submitted to the NHMRC for approval of the recommendations under section 14A of the NHMRC Act.
NATURAL THERAPIES REVIEW-TRANCHE 1
Closed 21 February 2020
The Department of Health has now opened a public invitation to submit evidence for Tranche 1 natural therapies through the Department's Consultation Hub. Guidance has been provided (including Evidence template ) to the public/stakeholders on what can be submitted. Tranche 1 therapies include naturopathy and western herbalism. For more information, please visit the Department of Health website.
NHMRC - GUIDELINES FOR GUIDELINES
Closed 20 February 2020
The NHMRC develops clinical practice guidelines and standards for developing clinical practice guidelines. They are conducting 2 public consultations regarding guideline methodology:
DEPARTMENT OF INDUSTRY SCIENCE ENERGY & RESOURCES - AUSTRALIAN MADE
Throughout 2018 and 2019, Complementary Medicines Australia ran a sustained advocacy campaign to ensure that medicines that were made in Australia under TGA Good Manufacturing Practices would be protected in making a Made in Australia country of origin claim. These efforts have been successful, with further information available here: http://www.cmaustralia.org.au/Australian-Made-Issues
CMA Submission - Clarifying eligibility for origin claims in the Complementary Medicines Sector (30 October 2019)
CMA Submission - Government Taskforce Complementary Healthcare Sector Country of Origin Labelling (January 2019)
TGA - Therapeutic Goods Administration
TGA Compounded medicines and good manufacturing practice (GMP)
TGO 92 updates
A targeted consultation limited to following occurred in July 2022:
This was intended to ensure that those with existing s14/14A "consents to supply" for non-compliance with TGO 92 s9(2) will - in most, if not all circumstances - be considered compliant and therefore no longer need to obtain these after the update is implemented. This is intended to occur prior to the current expiration date of the notices on 31 August 2021.
A more comprehensive public consultation will be released on other aspects of TGO 92 in the next 1-2 years to be completed prior to the sunsetting of both orders on 1 October 2026.
TGA Consultation mecobalamin - Dual name labelling transition to sole ingredient names
Closing 19 December 2022
The TGA is seeking views on whether the dual naming of certain ingredients, including mecobalamin (comethylcobalamin) should end on 30 April 2023. Feedback to the consultation will help to inform the TGA’s approach to how dual labelled medicine ingredient names will need to appear on labels and PI/CMI documents of medicines released for supply from 1 May 2023.
TGA consultation on Pharmacovigilance: Proposed changes to Safety Reporting requirements
Closing 5 December 2022
The TGA are seeking feedback, closing 5 December 2022, on proposed changes to Safety Reporting requirements as described in the Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements guidance document (the PV Guidelines). The intention of the proposed changes is stated to increase the quality of notifications, enabling the TGA to act on all safety issues in a timeframe proportionate to the risk to public health. The TGA also state that the aim is not to lessen the current requirements for reporting of safety issues, but to better define which issues are to be notified urgently by sponsors, supporting timely responses to new safety information by the TGA.
Boundary and combination products - medicines, medical devices, and biologicals
Closed 20 November 2022
The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’. The purpose of the draft guidance, which is intended to replace the existing guidance dated November 2005, 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.
User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version
Closed 26 October 2022
This online survey is seeking feedback on stakeholder experience of the beta version of the database of adverse events notifications (DAEN), providing the opportunity for stakeholders to identify any areas of the beta version that are problematic or not fit for purpose prior to implementation.
Regulatory options to potentially allow references to the TGA in therapeutic goods advertising
Closed 7 November 2022
This public Consultation considers potential options on whether allowing references to the TGA in therapeutic goods advertising (and on product labels) may support consumers to make better informed health decisions by more clearly identifying products that have met the regulatory requirements and are being lawfully advertised and sold.
The TGA are seeking feedback on:
- whether references to the TGA should be allowed in therapeutic goods advertising the class or classes of therapeutic goods, if any, that should be allowed to refer to the TGA;
- options for what a reference to the TGA could look like;
- options for how an authorised reference to TGA may be used in advertising; and
- whether references to TGA should be optional or mandatory for advertisers.
Proposed amendments to the Poisons Standard - Green Tea extract; Melatonin
Closed 29 September 2022
Green Tea extract- A private applicant has proposed that a new Schedule 2 entry for green tea extract be included in the Poisons Standard in preparations for internal use, unless they are labelled with specified warning statements which warn consumers of the potential for liver harm. This amendment would remove green tea products not bearing the specified warning labels from general sale. Green tea extract is not specifically scheduled in the current Poisons Standard.
Melatonin -A private applicant has proposed the rescheduling of immediate release melatonin from Schedule 4 to Schedule 3 for the treatment of jetlag. The rescheduling would apply to divided preparations containing 5 mg or less of melatonin, in packs of no more than 10 dosage units, for adults aged 18 and over. This will allow access to melatonin for this indication, without a prescription, after consulting with a pharmacist.
Proposed changes to the Permissible Ingredients Determination - Low-negligible risk 2022-2023
Closed 15 September 2022
The TGA have have published the annual low-negligible risk public consultation paper for changes to the Permissible Ingredients Determination,
The proposed changes relate to:
- Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata; and
- Liver injury associated with Valeriana officinalis.
The consultation proposes applying a new warning statement for Valeriana officinalis and an updated warning statement for Chelidonium majus and Larrea tridentata which are essentially the same except for the required name of the herb.
Proposed amendments to the Poisons Standard: Lead - including in complementary medicines
Closed 16 September 2022
The TGA have published an interim decision to make a variety of changes to the scheduling of lead.
The delegate has decided to delete the existing Schedule 4 entry for lead for therapeutic use and introduce a new Schedule 10 entry, which will include an exemption for therapeutic preparations containing 10 mg/kg or less of lead. This exemption limit was already previously applied to the existing Schedule 4 entry under Part 1, paragraph (2)(j) of the Poisons Standard, which applies a general limit for all substances listed in Schedules 1-6. The amendment effectively changes the classification of any therapeutic preparations containing greater than 10 mg/kg of lead from prescription-only medicines to products prohibited for sale, supply and use. A value of 10 mg/kg is equivalent to 0.001% w/w or 10 ppm.
Proposed amendments to the Poisons Standard Dichloromethane (methylene chloride)
Closed 27 May 2022
Dichloromethane (methylene chloride) is currently included in Schedule 5 of the Poisons Standard and is currently reflected by TGO 101 and the Permissible Ingredients Determination as a residual solvent, per the ICH IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R8). The Scheduling proposal is to include Dichloromethane (also known as methylene chloride, methylene dichloride; methylene bichloride) in Schedule 10 – this means it would not be able to be used under any circumstances.
TGA Consultation: Proposed update to the evidence guidelines for listed medicines
Closed 1 April 2022
The Evidence guidelines for listed medicines consultation is now open. The TGA is seeking feedback on the updated 'Listed medicines evidence guidelines - How to demonstrate efficacy of listed medicines', which is intended to replace the existing Guidelines. The TGA will be providing two webinars during the consultation period to outline the proposed changes to the Guidelines and give an opportunity for interested parties to give early feedback on the update. Information on the webinars will be published on the TGA website.
TGA Consultation: Fees and Charges Proposal 2022-23
Closed 7 March 2022
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%, including a proposal to apply new fees for variations on Clinical Trial Approval (CTA) schemes Members are encouraged to present their comments through CMA in order to provide a consolidated industry response to the TGA. The Consultation paper can be viewed here. Please provide any feedback to the consultation to CMA by Mon 28 Feb 2022 via firstname.lastname@example.org.
Survey on publication listed medicine compliance review results
Closed 31 March 2022
Since December 2019, as part of the Government's reforms to enhance the post-market monitoring system of listed medicines, the TGA publishes results of listed medicine compliance reviews in a database on their website. The database provides consumers quality and safety information relating to listed medicines that have been reviewed by the TGA. The TGA is seeking feedback on how effectively information relating to the results of listed medicine compliance reviews is being conveyed to consumers via an online survey.
Notification form: Reclassification of medical devices that are substances for introduction into the body
Closed 25 May 2022
If you are a sponsor/manufacturer/ distributor of a medical device composed of substances for introduction into the human body and your device was included in the ARTG prior to 25 November 2021, or you have submitted an application for inclusion in the ARTG prior to 25 November 2021 then you need to:
- Notify the TGA before 25 May 2022 or within 2 months of the start date of your ARTG entry using this form, that you have an inclusion that will need to be reclassified; and
- Submit an application for your device to be included in the ARTG under the correct classification before 1 November 2024.
Adoption of certain international scientific guidelines in Australia
Closed 20 February 2022
The TGA is conducting a public consultation seeking feedback on whether certain international scientific guidelines should be adopted. International scientific guidelines are not limited to prescription medicines, but may also apply to over-the-counter (OTC), complementary and some listed medicines. While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified. The TGA are seeking feedback on whether or not certain international scientific guidelines, as detailed in the online survey, should be adopted.
Improving access to medicine adverse event data – sponsor survey
Closed 18 Feb 2022
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 TGA how to best tailor what data sponsors would like to view or extract. This survey is part of the TGA’s Medicines Adverse Event Data Exchange project, seeking 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.
Proposed amendments to the Poisons Standard- Cannabis and tetrahydrocannabinols
Closed 31 January 2022
A private applicant has proposed the introduction of Schedule 7 entries for cannabis and tetrahydrocannabinols for use in analytical and scientific research. The amended entries would allow access to cannabis and its derivatives for use in research without Schedule 9 requirements, which can include specific approval from State and Territory health departments.
Public consultation on interim decisions to amend the Poisons Standard -amygdalin & hydrocyanic acid
Closed 1 November 2021
The TGA have published a notice of interim decision to amend (or not amend) the Poisons Standard in relation to matters referred to the Advisory Committee on Medicines (ACMS #34 - June 2021), on their website, which includes the Delegate’s Interim Decision on amygdalin & hydrocyanic acid.
The Consultation is now open on this interim decision until 1 Nov 2021 so that the Delegate may make a final decision leading to a planned implementation date of 1 February 2022.
The Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the scheduling for amygdalin and hydrocyanic acid in the current Poisons Standard. The ACMS advised that the current scheduling for amygdalin and hydrocyanic acid remains appropriate, with recommendation to add a new index entry for ‘apricot kernels’ with cross references in the index entries for both amygdalin and hydrocyanic acid.
Proposed amendments to the Poisons Standard - Cannabis and tetrahydrocannabinols for veterinary use
Closed 7 October 2021
The TGA are consulting on Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings, November 2021, including a proposal to amend the existing Schedule 8 entries for cannabis and tetrahydrocannabinols to include veterinary use of these substances (except in animals for human consumption.
Proposed Changes to RASML – Melatonin
Closed 17 September 2021
The TGA is seeking comment on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing melatonin for oral use, for inclusion in the Required Advisory Statements for Medicine labels (RASML).
The proposed changes will apply only in RASML to registered medicines; there are currently no RASML warning statements for melatonin. Melatonin is in included in Schedule 3 of the Poisons Standard and therefore is not eligible for inclusion in listed medicines and not currently included in the Permissible Ingredients Determination (certain homeopathic preparations may be exempt from listing requirements).
Proposed updates to the Permissible Ingredients Determination
Closed 29 September 2021
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:
Targeted TGA Consultation: Remaking Restricted Medicine Specification – Relevant to Sponsors with Schedule 3 Registered Medicines
Closed 16 August 2021
The Restricted Medicine Specification 2011 (the Specification) is due to sunset on 1 October 2021 and the TGA is proposing to remake the Specification without substantial amendment. This consultation is relevant to sponsors with, or who are intending to include, registered complementary medicines that are in Schedule 3 or Schedule 4 of the Poisons Standard, and will mean that these products will continue to be required to submit a Product Information as part of a registration application (no change). Please read CMA’s 19 July Technical Alert for more information.
TGA Interim Decision Hemp Seed Oil
Closed 17 August 2021
This interim decision would allow hemp seed oil complying with certain conditions on lower limits for cannabidiol and tetrahydrocannabidiols to no longer be scheduled and be sold for internal use in therapeutic goods. Please note that if the down-scheduling proceeds as proposed, this does not automatically permit use in listed medicines until a successful application is made for the Permissible Ingredients Determination. Please also note that this interim decision includes a limit for cannabidiol in hemp seed oil, however it does not amend the decision for cannabidiol in Schedule 3.
Proposed changes to the T.G. Advertising Code
Closed 18 June 2021
The TGA is seeking feedback on proposed changes to the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The consultation provides that the changes/improvements proposed by the TGA are intended to minimise unnecessary compliance costs while continuing to ensure that advertising does not contribute to any unsafe or improper use of advertised products.
Different mechanisms for improving the Code have been proposed; for some provisions, minor wording changes have been proposed as well as the addition of new definitions and notes to improve clarity; for others, feedback is sought on options for combining provisions and other more significant changes.
Proposed amendments to the Poisons Standard: Eugenol
Closed 4 June 2021
The Delegate of the Secretary of the Commonwealth Department of Health (the Delegate) proposes to amend the current Schedule 6 entry for eugenol to reduce concentration cut-offs for cosmetic preparations intended for skin contact, depending on whether the product will be rinsed off or not.
Proposed amendments to the Poisons Standard: Amygdalin and hydrocyanic acid
Closed 27 May 2021
The TGA have published a new consultation on a proposed amendment to the Poisons Standard for amygdalin and hydrocyanic acid.
The new Scheduling proposal is to exclude these substances from Schedule 10 and Schedule 4, respectively, at specified lower levels.
This latest consultation follows the recent publication of a Delegate’s final decision on 22 April 2021 to not amend the Poisons Standard in relation to a previous proposal to decrease the current scheduling.
The proposed unscheduled amount (the amygdalin equivalent of 0.3mg hydrocyanic acid, provided it is also less than 5mg of amygdalin) would become eligible for listing if the Delegate approves the proposal and be the upper permissible limit for a listed medicine per maximum recommended daily dose.
Proposed Changes to Required Advisory Statements for (Registered Complementary) Medicine labels – Menthol and Methyl salicylate
Closed 18 May 2021
Two sperate consultations are now open on proposed changes to required advisory statements for Registered Complementary Medicines containing menthol and methyl salicylate.
The TGA is seeking comment on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing either menthol or methyl salicylate for dermal use, for inclusion in the Required Advisory Statements for Medicine labels (RASML).
The proposed changes apply only to registered medicines. Requirements for menthol and methyl salicylate for listed medicines have already been implemented and are included in the Permissible Ingredients Determination.
Both consultations can be found at the Department of Health Consultation Hub
TGA Fees and Charges Fees Proposal 2021-22
Closed 17 March 2021
The TGA is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2021- 22 financial year. Specifically, feedback is sought on the potential impact/s of the proposed options, prior to seeking approval from the Government for any changes. The consultation provides that the preferred option is to increase all fees and charges by an indexation factor of 1.05%, this amount is lower than that which has been applied in recent years.
Efficacy monographs for listed medicines
Closed 26 February 2021
The TGA are conducting a targeted consultation on two draft efficacy monographs for vitamins B6 and B12. The purpose of this consultation is to provide relevant stakeholders and interested parties with an opportunity to provide feedback on two draft efficacy monographs and to help refine their content. Specifically, the TGA is seeking feedback on whether:
TGA consultation on discontinuing Active / Herbal Proprietary Ingredients and some Excipient PIs
Closed 24 February 2021
The TGA have released the public consultation on discontinuing new applications for Proprietary Ingredients (ingredient mixes) in the Proprietary Ingredients Table, specifically for Active Ingredient mixes (such as ingredients containing vitamins or minerals), Active Herbal mixes, as well as the non-specific excipient category (other excipient mix categories are unaffected). PIs are blends of ingredients that the supplier enters into the TGA database and obtains a number which sponsors can then use to add those ingredient mixes to their ARTG listing (or registration).
The TGA have outlined two proposals within the consultation:
1. Discontinue processing of active ingredient mixtures (Proprietary Ingredients) into the Proprietary Ingredients Table
2. Discontinue processing applications for non-specific Excipient Mixes into the Proprietary Ingredients Table
Proposed amendments to the Poisons Standard - hemp seed oil
Closed 27 January 2021
A private applicant has proposed amendments to the existing Schedule 9 entries for cannabis and tetrahydrocannabinols to exclude hemp seed oil for oral consumption from Scheduling when compliant with the food standards code.
Compounded medicines and good manufacturing practice (GMP)
Closed 18 December 2020
The TGA have announced a consultation on Compounded medicines and good manufacturing practice (GMP)following the adoption in July 2020 of the PIC/S Guide to GMP PE009-14 as the Manufacturing Principles for medicinal products. The guidance document (v3) is being updated to align with contemporary expectations and includes additional guidance in relation to:
- the product expiry of compounded medicinal products
- compounding of radiopharmaceutical products
- information for manufacturers of dose administration aids (DAAs).
Public Consultation on Interim Decision on Scheduling of Cannabidiol
Closed 13 October 2020
The TGA have published a notice of interim decisions made under Regulation 42ZCZN of the Therapeutic Goods Regulations 1990 in relation to proposed amendments to the current Poisons Standard which were referred to the Joint ACMS-ACCS in June 2020.
The TGA’s interim decision on CBD was to not permit CBD for general sale but to place low dose (60mg) CBD into “Pharmacist Only” Schedule 3, on the condition that CBD is included in a medicine that is in the ARTG (Appendix M requirement). This decisions means CBD must have high-level evidence to become an ARTG “Registered” medicine, and is likely to further delay consumer access and affordability as companies seek to demonstrate registration level clinical evidence for an indication at a very low dose (60mg).
Consultation on Permissible ingredients annual changes 2020-21
Closed 6 October 2020
The TGA have announced a consultation regarding proposed ingredient changes to the Therapeutic Goods (Permissible Ingredients) Determination (‘the Determination'). This consultation is conducted on an annual basis to consider changes the requirements of the Determination for issues which are considered to be “low to negligible risk”. Affected ingredients in the 2020 consultation are:
CONSULTATION ON THE NEW THERAPEUTIC GOODS ORDER 106 - DATA MATRIX CODES AND STERILISATION OF MEDICINES
Closed 20 August 2020
The Therapeutic Goods administration is seeking feedback on proposed requirements for sterilisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. The Standard will not mandate the serialisation of medicines nor the use of data matrix codes on medicines. However, it is proposed that compliance with the TGO 106 is expected for medicines when a data matrix containing a Global Trade Item Number (GTIN) is used on the primary pack, or when a medicine is serialised, either at the primary pack or unit dose level.
Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meetings, March 2020
Closed 9 July 2020
The TGA consulting upon the interim decisions made by a delegate of the Secretary under regulation 42ZCZN in relation to proposed amendments to the current Poisons Standard which were referred to an expert advisory committee under subdivision 3D.2 of the Regulations in March 2020. The consultation included proposed amendments to the scheduling of Arbutin and Melatonin.
PROPOSED AMENDMENTS TO THE POISONS STANDARD - CANNABIDIOL
Closed 22 May 2020
There are two "down scheduling" consultations currently open, seeking public submissions on what form this consumer access may take. The Australian Government is proposing low-dose access via Pharmacists only and a private applicant is proposing wider consumer access. Submissions must be received by no later than 22 May 2020.
TGA Interim decisions on proposed amendments- Cannabidiol- 9 September 2020
CMA Submission to the Delegate's interim decision - Cannabidiol- 13 October 2020
PROPOSED AMENDMENTS TO THE POISONS STANDARD-
METHYLISOTHIAZOLINONE & METHYLCHLOROISOTHIAZOLINONE
Closed 18 May 2020
Due to high skin sensitisation incidence and prevalence, changes to the scheduling for these excipient ingredients has been proposed.
Decisions on the proposed amendments will be published as interim decisions on the TGA website 9 Sep 2020
SCOPE OF REGULATED SOFTWARE BASED PRODUCTS
Closed 13 May 2020
The TGA is seeking feedback from stakeholders on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices in Australia.
INDEPENDENT REVIEW OF THE REFORMS TO THE THERAPEUTIC GOODS ADVERTISING FRAMEWORK
The independent review of the advertising reforms (the Review) has now commenced, and is being led by Ms Rosemary Sinclair AM. In February 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new advertising measures within two years from the commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018. TGA website
Closed 5 March 2020
Item 1.3. Interim decision in relation to calcifediol
Item 3.1. Interim decision in relation to caffeine
The related CMA Tech Alert provides further background information.
Outcome 7 May 2020 - Notice of final decision to amend the poisons standard.
-New Schedule 4 and Schedule 6 entries have been created for caffeine
-A new Schedule 4 entry for calcifediol has been created (for human internal use with a concentration cut-off of 10 micrograms or less calcifediol per recommended daily dose)
FEES & CHARGES 2020-21
Closed 28 February 2020
The TGA have released a document for consultation, seeking comments from interested parties on the proposed changes in fees and charges for 2020-2021. The TGA encourages CMA members to provide feedback through CMA in order to receive consolidated industry feedback.
Outcome 23 June 2020 - The Government approved the indexation based increase of 1.95% to all fees and charges, subject to rounding.
ARBUTIN AND MELATONIN- PROPOSED SCHEDULING
Closed 10 February 2020
CMA' s response to the consultation supports the proposed amendment, along with a request for the TGA to acknowledge the interim decision made by joint committees in September 2019, which if ratified would have made arbutin containing herbs available earlier in 2020.
Outcome 10 June 2020 - Consultation on Notice of interim decisions on proposed amendments to the Poisons Standard.
EVIDENCE GUIDELINES - LISTED MEDICINES
EU GUIDELINES - Annotation of the European Union Guidelines in respect of traditional medicines
An Annotation to two EMA guidelines is proposed stating that they cannot be used in CM applications as Australia has a guidance document referring to 75 years of use.
EXPORT OF THERAPEUTIC GOODS
Closed 3 February 2020
The TGA is seeking feedback regarding a guidance document related to the export of medicines from Australia. The document provides guidance on all aspects of the process, including: regulation, controlled substances, export only medicines, the application process and export certificates. This consultation is relevant to:
- Australian sponsors planning to export medicines.
- Authorised agents on behalf of a sponsor.
- People planning to export for non-commercial use.
CHANGES TO PERMISSIBLE INGREDIENTS - LOW-NEGLIGIBLE RISK
Closed 11 October 2019
The TGA released a document for consultation on 30 August 2019, seeking comments from interested parties on the proposed ingredient changes, categorised as being of low-negligible risk.
CMA’s submission addresses proposed changes to the 26BB Permissible Ingredients Determination; specifically, for Boron, Withania somnifera and Vitex agnus-castus.
Outcome 20 Feb 2020 -TGA Outcomes: Changes to permissible ingredients - Low-negligible risk
PUBLICATION OF EXCIPIENTS ON THE ARTG
Closed 10 October 2019
In response to feedback sought by the TGA on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG), CMA’s submission supported industry’s position, and addressed a range of issues including impacts on IP, regulation and proprietary ingredients.CMA Submission - Increased online access to ingredient information
Outcome 23 Jan 2020 - TGA response to increase online access to ingredient information
FSANZ - Food Standards Australia & New Zealand
FSANZ Consultation on the Regulatory framework for sports foods
TBA late 2022
FSANZ Review of the kava standard
Closed 16 November 2022
In March 2022, the FSANZ Board approved a variation to the Australia New Zealand Food Standards Code (the Code) after considering an urgent proposal to clarify the existing permission for kava. Under the urgent proposal provisions, FSANZ has assessed the resulting variation and is calling for submissions to help decide whether to reaffirm the variation or prepare a proposal to amend or repeal the variation. The purpose of the review is to ensure provisions for kava in the Code continue to protect public health and safety after Australia lifted the ban on commercial importation of kava from 1 December 2021.
FSANZ P1028 – Infant Formula
Closed 17 June 2022
FSANZ invites written submissions on the assessment of the Proposal P1028 - Infant formula. The assessment summarises FSANZ considerations to date and presents preferred options for potential amendments to Standard 2.9.1, Schedule 29, and other standards relevant to infant formula product requirements.
FSANZ will continue to engage with stakeholders throughout the proposal process, including undertaking workshops during the first consultation period and releasing a second public consultation later in 2022.
FSANZ A1233 -2’-FL from new GM source for infant formula
Closed 31 January 2022
This application seeks to permit 2′-fucosyllactose (2′-FL), produced by genetically modified Escherichia coli K-12, in infant formula products. The Code already permits the addition of 2′-FL as a nutritive substance to IFP. However, this permission does not apply to the 2′-FL produced using E. coli K12 containing the gene for alpha-1,2-fucosyltransferase from Bacteroides vulgatus which has a different genetically modified source organism and specifications. The application therefore seeks to amend Schedule 26 to permit this alternative genetically modified source organism.
Proposal P1057 - Review of the kava standard
Closed 23 December 2021
FSANZ are calling for public comment on Proposal P1057 – Review of the kava standard and declared it urgent. This review supports a Federal Government pilot program that will allow commercial importation of kava into Australia to build stronger cultural and economic ties with Pacific Island nations. Kava beverage has a long history of consumption in the South Pacific and plays an important role in traditional community ceremonies. In its review, FSANZ aims to clarify the existing permissions for kava in the Australia New Zealand Food Standards Code to: - limit the preparation and consumption of kava beverages to traditional use, and
- ensure that food additives and processing aids may not be added to dried or raw kava root or kava beverages.
FSANZ expect to complete the urgent part of the review in the first quarter of 2022.
FSANZ P1028 – Infant Formula
Consultation 3 of 3
Closed 20 October 2021
This consultation paper represents the third a series of three consultations on infant formula, and covers the regulatory framework and definitions for Standard 2.9.1 and Schedule 29.Particularly, the regulatory framework for special infant formula products for special dietary use (IFSDU) under the current provision in the Code.
FSANZ Call for Data - P1010
Closed 9 September 2021
FSANZ are currently reviewing Standard 2.9.4 – Formulated supplementary sports foods, and accompanying requirements in the related Schedules. This Review will include the assessment of data in support of changes to the code, such as allowable quantities of substances and the addition of innovative substances.
The data FSANZ are seeking includes data:
- Based on scientific research – this can be published or unpublished;
- On one or more outcomes relevant for human health and/or sports performance, at different levels of intake (animal and human studies will be accepted); and
- Technical information supporting the characterisation of the commercial preparations of contemporary substances (i.e. specifications, stability data, validated analytical methods).
FSANZ P1028 – Infant Formula
Consultation 2 of 3
Closed 2 September 2021
This consultation paper represents the second in a series of three consultations on infant formula, and covers safety and food technology. The focus of this paper is on nutrient composition for macronutrients and energy, vitamins and minerals, permitted forms and other nutritive substances. Where relevant, the prescribed minimum and maximum type and value for the nutrient is discussed, as well as related information such as calculations.
FSANZ Review of titanium dioxide as a food additive – call for data
Closed 17 September 2021
Food Standards Australia New Zealand (FSANZ) is calling for data on titanium dioxide and its safety when used as a food additive in Australia and New Zealand. Information supplied through the call will assist FSANZ in reviewing the safety of titanium dioxide as a food additive following the recent release of an updated safety assessment by the European Food Safety Authority (EFSA).
FSANZ P1028 – Infant Formula
Consultation 1 of 3
Closed 7 July 2021
This consultation paper represents the first in a series of three consultations on infant formula, and covers safety and food technology. The focus of this paper is on issues relating to the safety and food technology of infant formula, from manufacture of the product to preparation by caregivers.
FSANZ A1178- A new way to measure fibre content in food
Closed 22 June 2021
The Australia New Zealand Food Standards Code (the Code) currently allows three methods for analysing total dietary fibre and four methods for analysing certain specifically named fibres. The proposed new method, if approved, would be permitted as an additional voluntary method of analysis for total dietary fibre and is stated to be more comprehensive than older methods in the Code for measuring total dietary fibre, particularly for those foods that contain multiple fibre types.
FSANZ Caffeine Review - P1056
Proposal P1056 will review the permissions for caffeine in sports foods and general foods and consider the risk it poses to sensitive sub-populations.
After considering all submissions received in response to the July 2020 Urgent Proposal P1054 - Pure and highly concentrated caffeine products consultation, the FSANZ Board approved a decision to prepare a proposal for the Caffeine review. The latest proposal seeks to address issues raised in the pure and highly concentrated caffeine products consultation which was prepared as an emergency interim response and prohibited the retail sale of foods in which total caffeine is present in a concentration of 5% or more (if the food is a solid or semi-solid food) or 1% or more (if the food is a liquid food). This prohibition came into force on 12 December 2019 and will remain in place until the completion of proposal P1056.
FSANZ/food regulation reforms
Closed 16 Nov 2020
Following a plan made by the Australia and New Zealand Ministerial Forum on Food Regulation in November 2019, a review of the food regulatory system including the Food Standards Australia New Zealand Act 1991 is occurring to ensure it remains strong, robust and agile into the future. Stakeholders are strongly encouraged to respond to the consultation, via online survey by 16 November. The consultation asks key questions about the regulation of foods, including items of key interest to you, including issues regarding the food-medicine interface and the possibility of regular, more holistic reviews of food standards. For more information please see the Department of Health’s Consultation Hub
PURE AND HIGHLY CONCENTRATED CAFFEINE PRODUCTS
Closed 11 September 2020
Following urgent public consultation after a review and report to Australian Government Ministers in August 2019 that found pure and highly concentrated caffeine food products posed an immediate and acute risk to consumers, FSANZ approved the prohibition of the retail sale of foods in which total caffeine is present in a concentration of 5% or more (if the food is a solid or semi-solid) or 1% or more (if the food is a liquid). This prohibition came into force on December 2019.
FSANZ has 12 months to undertake a full assessment of the prohibition and decide whether to confirm, reject or amend the approved variation. FSANZ are calling for submissions to help decide to reaffirm the variation or to prepare a proposal to amend or repeal the variation.
PLAIN ENGLISH ALLERGEN LABELLING
Closed 27 February 2020
The Government has recommended that this be finalised by Sep 2020.
FSANZ have released a second call for submissions in relation to a proposal to make allergen labelling requirements clearer and more consistent by including requirements for how and where the declarations must be made on food labels. FSANZ is therefore proposing to amend the Code to require the following:
The separate declaration of:
-individual tree nuts
- individual gluten grains.
·the use of mandatory specified terms of the allergen source when declaring allergens.
·For packaged foods:
- the declaration of allergens in the statement of ingredients using bold font and in a separate emboldened allergen summary statement.
Final changes: FSANZ update
URGENT PROPOSAL P1054 PURE and HIGHLY CONCENTRATED CAFFEINE PRODUCTS
Closed 14 November 2019
CMA’s response to FSANZ’s proposal to prohibit the retail sale of pure and highly concentrated caffeine food products addresses importation of caffeine containing products, the potential risks of over-regulation and the need for further clarity for stakeholders at the food-medicine interface.
Outcome 12 Dec 2019 - FSANZ Final consideration report
Complementary Medicines Australia supports appropriate government regulation for complementary healthcare products that recognises the low risk nature of the products whilst upholding safety, quality and efficacy standards necessary to ensure consumer confidence.
Submissions to the Therapeutic Goods Administration
The following submissions are in response to the following TGA consultation documents:
CMA Submission - Proposed Amendments to the Poisons standard -Cannabidiol
CMA Submission - Caffeine Scheduling
CMA Submission - Fees and Charges 2020-2021
CMA Submission - Arbutin and Melatonin - Proposed Sheduling
CMA Submission - Changes to permissible ingredients - Low-negligible risk
CMA Submission Caffeine Proposal - P1054 Pure and highly concentrated caffeine products
CMA Submission - EU Guidelines proposal to adopt ICH-Q3D for all listed medicines including herbal medicines.
CMA Submission - (New TGO 101 - Standard for Tablets, Capsules & Pills) - Remaking Therapeutic Goods Order No. 78
CMA Submission - TGA Fees and Charges 2019-2020
14 November 2019 FSANZ Submission P1054 Pure and highly concentrated caffeine products
30 October 2019 Consultation Regulation Impact Statement for the Legislative & Governance Forum on Consumer Affairs - Clarifying eligibility for origin claims in the Complementary Medicines Sector
January 2019 CMA Submission - Complementary Healthcare Sector Country of Origin Labelling Government Taskforce
CMA Submission - Complaints handling - Advertising of therapeutic goods to the public (June 2018)
CMA Submission - The 2018 Therapeutic Goods Advertising Code & associated guidance (April 2018)
CMA Submission- Proposal to change the current good manufacturing practice (GMP) fees and charges ( March 2018)
CMA Submission - Discontinuing pre-market evaluation of Herbal Component Names (12 January 2018)
CMA Submission - Permitted Indications (1) - Health maintenance biomarker claims (October 2017)
CMA Submission - Permitted Indications (2) - Mild and Medically Diagnosed Conditions (October 2017)
CMA Submission - Permitted Indications (3) - Maternal Health & Infancy (October 2017)
CMA Submission - Permitted Indications (4) - Tradition of Use Evidence Qualifiers (October 2017)
CMA Submission - Therapeutic Goods Advertising Code Proposed improvements (13 October 2017)
CMA Submission - Exposure Draft of the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (5 September 2017)
CMA submission to the consultation - Options for the future regulation of 'low risk' products (12 May 2017)
CMA submission to the consultation - Reforms to the regulatory framework for complementary medicines: Assessment pathways (28 March 2017)CMA submission to the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 inquiry. - Click here to read the submission (3 March 2017)
Food Standards Australian New Zealand Submissions:
CMA Submission to FSANZ - Proposal P1044 - Plain English Allergen Labelling (PEAL) (May 2018)
CMA's goal is to achieve a sustainable vibrant, compliant industry that holds its place in consumer health. We support the ethical and responsible promotion of complementary healthcare products and their value to the health of our community.