We asked, You said, We did

The current exclusion of certain assistive technologies from regulation is increasingly unsuitable due to technological advancements, changing supply models, and growing customer demand. This consultation is required to ensure regulations for fit-for-purpose. We invited feedback from stakeholders on two (2) proposals to improve the regulation of assistive technologies:

1. The removal of the current exclusion
2. Exempt goods from the need to be included in the Australian Register of Therapeutic Goods (ARTG).

We received 25 submissions from a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of assistive devices and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments.

Proposal 1: Remove current exclusion

1. Stakeholders were asked whether they broadly agreed with the proposal to remove the current exclusion of “household and personal aid, or furniture and utensils”.

• The responses were mixed, the majority were for the removal of the exclusion. Disagreeing respondents consisted of industry representatives and assistive device providers.
• Respondents who agreed with the proposal suggested that TGA should have improved oversight of these products and that it would improve regulation of them. Some stakeholders said the removal may improve quality assurance of the products and ensure reporting of adverse events. Agreeing respondents noted that the growing complexity of the marketplace requires increased regulation.
• Those that disagreed suggested that the removal may lead to over-regulation and risk the incurrence of additional administrative costs and fees. This burden would ultimately fall on the customer. The disagreeing respondents were industry representatives.

2. Stakeholders were asked to list the financial impacts if the current exclusion were to be removed and what timeframe they would need to implement the proposed changes.

• There was a broad concern that the removal of the current exclusion will have a flow-on effect for the customer. Industry representatives suggested that a removal would increase compliance burden, time and money adjusting documentation and obtaining approvals.
• Respondents said that they would like to have a high quality, accessible, available in many languages source of information as guidance through this transition. There was also concern for a disproportionate impact on small business vendors from the respondents.
• There was broad support for a 1–2-year transition period for the proposal to be implemented. There was also suggestion for a phased approach. An institutional representative noted that the transition may take more than 2 years, if the changes were to be complex.

Proposal 2: Exempt goods from the need to be included in the Australian Register of Therapeutic Goods (ARTG)

1. Stakeholders were asked if they agreed with the proposal to exempt some assistive technologies.  

• Respondents suggested that “lower-risk” items to be exempt from ARTG inclusion. Examples provided included non-weight-bearing devices, those not customized to clients’ specifications, and devices commonly used in everyday settings.
• Industry representatives were concerned an exemption would exacerbate compliance burdens and have limited impact on reducing the cost of regulatory compliance. Exemptions – a couple of industry representatives noted – could impede on innovation within the sector and discourage producers from meeting quality standards.

2. Stakeholders were asked about what information regarding assistive technology they would like to be made public and how it should be organised.

• The responses were mixed. Respondents who wanted information about exempt products were from industry, consumer groups and allied health professionals. Stakeholders noted that devices, organisations, NDIS providers, schools and educational settings, hospitals should be on the list. Agreeing respondents also emphasised that the list should be clear and easy to follow to ensure compliance.
• A disagreeing respondent suggested that it may be “over-kill” since the exemption will likely apply to low-risk products.

• Stakeholders also said that information about exemptions should not be made publicly available where there is a risk of breaching privacy or confidentiality.

Boundaries

1. Stakeholders were asked about which boundary product they thought should be medicalised and which that should not.

• Several respondents suggested that boundary products should not be medicalised because it will restrict supply and are used mostly in every-day settings.
• Respondents suggested a risk-based assessment to decide on exemptions and medicalisation of products.

Further feedback

Stakeholders requested increased clarity and details on how these proposals might be implemented. They asked for more details on the specific issues TGA have experienced with regulating exempt medical devices and assistive technologies. Several stakeholders asked that the TGA conduct educational activities and improve website guidance to increase sponsor awareness and compliance with TGA regulatory requirements for assistive technologies.

Submissions, where permission has been granted, will be published soon.

We have reviewed the feedback provided for this consultation paper. Your feedback will inform internal discussions and further consultations with stakeholders. We will inform stakeholders about any further consultations or related policy updates.

The TGA sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes were intended to address the following issues:

1. Herbal ingredients with pregnancy contraindications and other toxic effects
2. Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury
3. Xanthium species
4. Phenoxyethanol
5. Clarification of hydration state for Rutoside.

A total of 9 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

• 6 responses to the proposed changes for herbal ingredients with pregnancy contraindications and other toxic effects
• 4 responses to the proposed liver warning statement for Garcinia species and related ingredients
• 7 responses to the proposed removal of Xanthium species
• 6 responses to the proposed update to the requirements for phenoxyethanol
• 4 responses to the proposed update to clarify the requirements for Rutoside.

The responses varied in stance and recommendations. The feedback from professional medical groups was supportive of most of the proposals, however the majority of respondents from the complementary medicines industry only partially supported the proposals, with many suggesting rewording or clarification of the proposed warning statements and requirements. See the Final Decisions Document for details of issues raised by respondents and the TGA’s response.

The feedback and recommendations provided by respondents were taken into consideration in making the final decisions to amend the Permissible Ingredients Determination for the ingredients discussed in the consultation. The final changes incorporate variation compared to the original proposals.

The final changes will commence on 1 March 2025. A 12-month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2026.

From 26 July 2024 to 23 August 2024, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the March 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written submission.

A total of 16 submissions were received through the consultation, 4 from individuals and 12 from organisations. A breakdown of the submissions can be found below.

CYTISINE: 5 submissions were received, 3 in full support, and 2 in partial support of the interim decision. 4 submissions provided a written component, 2 in support and 2 in partial support.

DEXTROMETHORPHAN: 4 submissions were received, 3 in full support, and 1 in partial support of the interim decision. Of these, 3 provided a written component, 2 written submissions in support, and 1 in partial support.

DIHYDROCODEINE: 7 submissions were received, 2 in partial support and 5 in opposition of the interim decision. All the 7 submissions included a written component.  

ETHYLMORPHINE: 2 submissions were received and both were in opposition of the interim decision. All the 6 submissions included a written component.  

OXYTETRACYCLINE: 1 submission was received which was in opposition of the interim decision and included a written component.

TRANEXAMIC ACID: 4 submissions were received and all in full support of the interim decision. Of these, 3 provided a written component.

ETHYL LACTYL RETINOATE: 6 submissions were received, 2 in full support and 4 were in opposition of the interim decision. All the 6 submissions included a written component.  

NICLOSAMIDE; No submissions were received.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard were published on 27 September 2024.

Final decisions on DIHYDROCODEINE and ETHYL LACTYL RETINOATE have been deferred while the submissions received from the consultation on interim decisions on these two substances are further considered.

The Therapeutic Goods Administration (TGA) undertook a public consultation relating to a proposal to introduce legislating regulatory categories for some boundary and combination products. The consultation sought feedback on whether:

• legislating some products to formally declare their regulatory category (e.g., medical device, medicine, or other therapeutic good), would improve clarity for stakeholders
• and if so, whether a transition period of five years would be sufficient for sponsors with affected ARTG entries.

The following products were considered in this consultation:

• Head and body lice products for humans
• Moisturisers and emollients
• Toothpastes (dentifrices)
• Products generated by ozone generators
• Weight loss treatments – ingested
• Vascular Access Device (VAD) locking solutions and
• Pre-filled saline flush syringes (PFSFS)

We also asked for feedback about the classification level for VAD locking solutions and PFSFS.

Thirty-four responses were submitted by a range of stakeholders including medical device manufacturers, sponsors, medical device industry peak bodies, State and Territory Health Departments, regulatory affairs consultants, health professionals and consumers. Most respondents represented medical device industry and medical device peak bodies, followed by government entities, regulatory affairs consultants, health professionals, and consumer.

Legislating regulatory categories for some boundary and combination products

The feedback overall indicated that legislating regulatory categories of products such as head and body lice products for humans, moisturisers and emollients, toothpastes (dentifrices), products generated by ozone generators, and ingested weight loss treatment as mentioned in the consultation paper would provide additional clarity on the regulatory requirements for these products. Feedback confirmed that this proposed change may assist manufacturers to meet the necessary regulatory requirements and potentially facilitate faster assessment of applications by the TGA for products to be included on the Australian Register of Therapeutic Goods (ARTG).

Those who did not support the proposal stated that legislating the regulatory categories would cause further confusion as a legislative approach would be restrictive in situations where it is difficult to determine the primary mode of action of the product. They said that often the TGA’s and the sponsor’s interpretation of ‘principle intended action’, ‘active ingredients’, and ‘active ingredient at unscheduled levels’ i.e. lower than what is mentioned in the Poisons Standard, do not align. It was also stated that further clarification is needed on products that have both pharmacological and physical mode of action, and products for cosmetic use.

It was suggested that if the proposal was implemented, that the TGA give consideration, where required, to ensure continuity of product supply in the Australian market while industry work towards transitioning any products. Most respondents supported a five-year transition period for affected ARTG entries and noted that this would allow sufficient time for the manufacturers to make necessary adjustments.

Sponsors also said they should be able to seek targeted guidance from the TGA including steps to help them correctly categorise their product. It was also highlighted that in some cases, manufacturers may choose not to transition affected products (ie: cease supply)

Vascular Access Device locking solutions and pre-filled saline flush syringes

Feedback received about the regulatory category and classification for VAD locking solutions and PFSFS was mixed. Some stakeholders raised concerns about these products being regulated as a medical device when they contain a medicine, and others raised concerns about the risk classification.

There were suggestions to regulate these products as both a medicine and a medical device, whereby the medicine component should be assessed as per medicine regulations with a requirement to provide pharmacokinetic data on local and systemic effects including antimicrobial resistance (AMR), noting that even a subtherapeutic dose of antibiotics can increase the risk of AMR. It was highlighted that products containing saline with or without added substances in general should be regulated to the highest available standards as storage and sterility of these products is very important.

It was noted that the saline in PFSFS, even if intended for flushing, is not aspirated in most cases, and often enters the bloodstream. Some respondents also said the concept of irrigation does not apply to these products as there is no drainage step following introduction of the saline. They said saline has an effect both locally and systemically through interaction with the blood and repeated doses, particularly in infants and patients with renal failure can have physiological effects. Other respondents claimed that the saline in these products when sold separately should be regulated as a medicine irrespective of the presence of added substances and argued that this qualifies these products to be regulated at a higher-risk classification.

Feedback in favour of the proposal stated that the regulatory categories and classification level mentioned in the consultation paper makes sense, is easy to understand, and provides needed clarity on the regulatory category of these products.

If regulatory changes were introduced, a five-year transition period for the effected products was supported by the majority of stakeholders as sufficient for manufacturers to adapt to any new requirements. However, it was noted that the ease of transition would depend on the size (small or large) and resources of the manufacturers. It was also suggested that the TGA could consider a shorter transition period for products containing antimicrobial and anticoagulants due to the higher risk associated with these products.

Other products suggested as needing additional clarity

A number of stakeholders also suggested other boundary and combination products that need additional clarity in relation to their regulatory categories, such as:

• Bone cement and other implantable products embedded with antimicrobials
• Alcohol swabs
• Lubricants and gels (eye lubricants, vaginal gels ultrasound gels, personal lubricants)
• Products that change the pH in a lumen, CO2 absorbers
• Wart, corn, and callus removal products
• Topical nail treatment solutions with antibacterial or antifungal ingredients
• Ear wax softener
• Saline nasal solutions (hypertonic, hypotonic, isotonic)
• Eye drops (hypertonic), and medicated artificial tears
• Dietary supplements
• Cosmeceuticals
• Homeopathic products
• Products used to cleanse dentures such as dental cleansing solutions and brushes for cleaning dentures.

As suggested by some stakeholders in their consultation feedback, the TGA organised targeted workshops to discuss the consultation paper and provide a forum to further explore comments made by respondents

Feedback from the workshops

Feedback from the majority of stakeholders from the medical device industry, health professionals and government entities supported legislating regulatory categories of head and body lice products, moisturisers and emollients, toothpastes, products generated by ozone generators and ingested weight loss treatment. It was also suggested that the TGA should:

• ensure alignment with other comparable overseas jurisdictions,
• provide risk-based justifications for any changes to a product’s regulatory category,
• provide more examples of these products through the published example list within the guidance forboundary and combination products,
• provide clearer guidance and interpretation of ‘primary mode of action’ and
• consider more stringent regulation of medical devices incorporating antimicrobials due to their potential to cause AMR.

Feedback on VAD locking solutions and PFSFS was mixed, with some stakeholders suggesting these products should be regulated as medicines, and others suggesting these products should be regulated as a medical device. Feedback was also divided on the risk classification of these products with some stakeholders suggesting these products to be low risk while others considered them to be high-risk.

We have reviewed the feedback received through the consultation responses and targeted workshops. The TGA is considering the feedback and may undertake further targeted consultations to finalise any policy positions before seeking Government consideration. We will inform stakeholders of the outcomes of the Government’s consideration including any changes to the regulatory categories or risk classification.

We asked for feedback on proposed updates to rules for medicine labels to:

1. Make sure that quantities of active ingredients in injectable medicines intended for electrolyte replacement are clear on labels and in units important to health professionals.
2. Make sure that clear instructions on how to prepare and store certain injectable medicines administered by healthcare professionals is available in the appropriate format.
3. Give consumers more information about large solid oral dosage forms on labels of listed medicines.

We received 60 submissions in response to this consultation. Respondents had a range of opinions about the 3 parts of the consultation.

Most respondents supported the proposed changes for expressing quantities of active ingredients in injectable medicines intended for electrolyte replacement. Some respondents suggested improvements to the proposed requirements.

We received mixed feedback about proposals for instructions for preparation of injectable medicines administered by healthcare professionals. Many respondents, including health professionals, raised concerns about electronic access to information when preparing medicines. For example, there may be situations where there is poor internet connectivity at time of administration, or where a QR code reader is not available or permitted.

We received a range of feedback about the proposed requirements for large solid oral dosage forms. Many respondents gave us feedback about the proposed dosage form sizes that would need information on the label.

We appreciate all the feedback we received and considered all responses before deciding on next steps.

Active ingredients quantities in injectable medicines intended for electrolyte replacement

We made changes to Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) to make medicine labels clearer for health professionals.

For injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less):

• The label must now express potassium chloride quantity in millimoles. Labels must also include the quantity of potassium chloride in weight except in certain circumstances.
• The label must continue to express the quantity of other active ingredients in weight. The label must also include the quantity in millimoles of each active ingredient.

We also used the feedback to make minor changes to the proposed requirements presented in the consultation paper. This gives more clarity to medicine sponsors about requirements for small containers containing potassium chloride.

Medicine sponsors have time to update labels with medicines manufactured or imported from 1 December 2026 having to comply with the updated requirements.

We have included guidance about the new requirements in Labelling medicines to comply with TGO 91 and TGO 92.

Instructions for preparation of injectable products administered by healthcare professionals

In response to concerns about access to electronic information at the time of administration, we are maintaining the current arrangement of requiring instructions for preparation of injectable medicines to be printed either on the label or as a package insert.  QR codes can be used but cannot replace printed information about how to prepare these medicines at this time. We have therefore not changed the requirements in TGO 91 about instructions for preparation.

However, we have updated the package insert template and Labelling medicines to comply with TGO 91 and TGO 92 to give more clarity to medicine sponsors about providing instructions for preparation.

We encourage medicine sponsors to supply electronic medicine information through machine readable codes on the label and other mechanisms (for example, QR codes), in addition to printed instructions for preparation.

Despite our decision at this time, we will reconsider the replacement of physical instructions for preparation in the future to support environmental benefits, technological advances, and international alignment. For example, we intend to seek feedback on updated proposals when we conduct a broader review of TGO 91 and TGO 92 in 2025.

Information on listed medicines about large solid oral dosage forms intended to be swallowed whole

We are still considering the feedback about proposed changes to TGO 92 to improve information about large oral dosage forms. We will inform stakeholders as soon as we decide on the changes to TGO 92.

More information about changes to medicine labels

Changes to medicine labels take time. We allow medicine sponsors time to update labels to support the medicine’s availability in the community. New labels appear gradually as new stock is distributed, and existing stock is used up. Medicines with new labels may be available at the same time as medicines with older labels.

For more information about the changes see:

• Updates to requirements and guidance for labels of injectable medicines

The Therapeutic Goods Administration (TGA) undertook a public consultation related to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs). The primary objective of the proposed changes were to improve the transparency, identification and awareness of products in these categories; thereby supporting faster action if safety concerns were identified.

There is widespread misunderstanding and confusion about what regulatory requirements manufacturers and sponsors need to meet if they supply exempt medical devices. Sponsors of these categories of goods are still subject to, and must meet, relevant regulatory obligations and they are subject to oversight by the TGA.

The consultation sought feedback from stakeholders on three (3) proposals to improve the regulation of exempt medical devices and exempt OTGs:

1. Require notification of supply to the TGA
2. Publish information about supply on the TGA website
3. Provision of information and samples of products to the TGA.

Thirty-eight (38) responses were submitted by a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of dentistry and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments. 

Proposal 1: Require notification of supply to the TGA
We asked stakeholders for feedback on the proposal to require notification of supply from sponsors of certain exempt medical devices and exempt OTGs as per Appendix A of the consultation paper.

The responses were mixed, with half supporting this proposal and the other half not supportive of any change. Respondents who agreed with this proposal suggested that it would improve the TGA’s oversight and monitoring of these products. Some stakeholders clarified they would be supportive of this proposal if multiple products could be submitted under one notification. Those that disagreed suggested that notifications of supply would increase costs and regulatory burden without increasing patient safety. Industry and healthcare providers said the current regulatory framework is sufficient, without introducing notifications of supply.

We also asked stakeholders which exempt devices and exempt OTGs should require notification of supply and what information should be provided in these notifications. There was broad support to require notifications for exempt OTGs, exempt clinical decision support software, and exempt medical devices manufactured by healthcare providers. 

Most stakeholders agreed that notifications of supply should include contact information about the sponsor (e.g. name and postal address) and details about the exempt devices and exempt OTGs (e.g. product description or intended purpose, kind of device or OTG). 

Proposal 2: Publish information about products being supplied
We asked stakeholders for feedback on the proposal to publish information about the notifications of supply of exempt devices and exempt OTGs on the TGA website. 

Most respondents agreed with the proposal to publish this information. Stakeholders supporting this proposal advised that publishing this information would support both patients and healthcare providers to make informed decisions about using exempt devices and exempt OTGs. They also suggested that publishing this information would increase transparency and accountability for manufacturers and sponsors. 

Stakeholders who disagreed with this proposal advised that consumers should always be encouraged to contact the healthcare provider in the first instance for any issues with the product. They also noted that the exempt products they supply do not have sufficient risk associated with them to necessitate the requirement for notifications.

It was also noted that, for OTGs, sponsor contact information is already on packaging, however, this does not provide clarity for the TGA if there are any problems or issues with the product – ie: the TGA is not able to contact the sponsor/manufacturer.

Stakeholders also indicated that information about exemptions should not be made publicly available where there is a risk of breaching privacy or confidentiality. (Note that “supply” in this consultation refers to an organisation that distributes a product – it does not refer to each individual instance of supplying a product to a particular consumer or purchaser). 

Proposal 3: Provision of information and samples to TGA 
We asked stakeholders for feedback on proposals to require sponsors to provide information about exempt devices and exempt OTGs and product samples to the TGA upon request. 

Most respondents agreed that sponsors should be required to give additional information and provide samples to the TGA upon request. Stakeholders said information requests should be limited to requests for information that sponsors or manufacturers are ordinarily required to have available to meet their regulatory requirements (eg: evidence of compliance with Essential Principles, logs of adverse events etc). Some stakeholders noted that the cost of providing product samples to the TGA for exempt personalised medical devices may be prohibitive and would not be suitable for exempt devices imported for personal use.

Further feedback
Stakeholders requested increased clarity and details on how these proposals might be implemented by the TGA. They asked for more details on the specific issues the TGA has experienced with regulating exempt medical devices and exempt OTGs. Several stakeholders asked that the TGA conduct educational activities and improve website guidance to increase sponsor awareness and compliance with the TGA’s regulatory requirements for exempt devices and exempt OTGs.

As suggested by some stakeholders through consultation feedback, the TGA conducted targeted workshops to further discuss topics related to the regulation of exempt devices and OTGs mentioned in this consultation paper. 

Targeted stakeholder workshop
The TGA organised a targeted stakeholder workshop in October 2024 to discuss outcomes of the public consultation, provide and seek clarification on some of the issues raised and seek further feedback. Thirty-nine (39) stakeholders attended including sponsors, industry peak bodies, dental and allied health professionals and regulatory affairs consultants. Most attendees had provided responses to the public consultation.

Feedback from the workshops showed that most workshop participants disagreed with the TGA collecting and publishing information on exempt devices and OTGs (proposals 1 and 2). Slightly more than half of the workshop participants disagreed with providing information and samples to the TGA upon request (proposal 3).

We asked stakeholders for feedback on the following new proposals for improving regulation of exempt devices and OTGs:

• Educational outreach activities to raise sponsor awareness of their regulatory obligations.
• Changing terminology for ‘exempt’ devices and OTGs that have notification requirements to improve regulatory clarity for stakeholders.
• Requiring adverse event reporting for exempt devices and OTGs.
• Amending mandatory periodic reporting requirements for exempt devices and OTGs to reduce regulatory burden.
• Using the Medical Devices Vigilance Program (MDVP) for certain exempt devices and OTGs.
• Investigating compliance monitoring and an associated resourcing fee model.

Stakeholders generally agreed with these new proposals, with some exceptions.

When asked if stakeholders agreed with mandatory periodic adverse event reporting for patient safety, they were generally supportive. However, when asked if they supported mandatory periodic adverse event reporting for their specific sector, they were less supportive. Slightly more respondents supported mandatory periodic adverse event reporting for exempt dental / orthopaedic devices made by healthcare professionals and exempt disinfectants, compared to custom made medical devices, low volume patient matched medical devices, exempt Clinical Decision Support Systems, tampons and menstrual cups. 

When asked if stakeholders supported using the Medical Device Vigilance Program (MDVP) for certain exempt devices and OTGs, some stakeholders were unfamiliar with what the MDVP was, whilst others were uncertain as to how the MDVP would be applied to their exempt product. A stakeholder noted that the MDVP would be a useful tool in lieu of periodic reporting. 

The TGA also held targeted discussions with the Advisory Committee on Medical Devices, the Women’s Health Product Working Group and the Medical Devices Consumer Working Group. These groups generally support the proposals for improved traceability, transparency and accountability for exempt goods.

Based on the feedback provided, we will continue to convene further targeted consultations with stakeholders in 2025 about the proposals.

We undertook a public consultation related to instructions for use (IFU) for medical devices. We asked for your feedback on how IFU are provided and whether these should be made available in more flexible formats.

The consultation was hosted on the TGA Consultation Hub and was open for feedback from 15 April 2024 to 4 June 2024. Below is a summary of feedback received for the consultation paper. 

One hundred and eight (108) responses were received from stakeholders including State and Territory health entities, health professionals, healthcare peak bodies, healthcare institutes, regulatory affairs consultants, consumers, and consumers peak bodies with most responses from medical device manufacturers and sponsors.

The feedback overall indicated support to change the requirements for providing IFU for medical devices, including allowing electronic instructions for use (eIFU) to be provided for a greater range of medical devices used by both professionals and consumers.

Responses from medical device manufacturers and sponsors noted that a shift towards eIFU will be cost effective for manufacturers, the instructions can be updated easily, additional information like safety concerns, recall, healthcare professional recommendations can be added instantly, and information can be provided in multiple languages.

Responses from medical device consumers, consumer peak bodies, health professionals, hospitals and hospitals peak bodies resonate with overall feedback that the requirements for IFU should move towards eIFU.

Responses noted that eIFU offers significant advantages for consumers and health professionals – it is convenient given almost everyone has access to a phone or computer, and allows flexibility in terms of language, font size, and supports environmental sustainability.

Responses also noted that if changing the requirements, careful consideration of accessibility, security, and regulatory compliance is essential to ensure that eIFU meet the needs of all users while maintaining safety standards.  

There was support for consumers who do not have internet access or are not confident using digital information to be able to access a paper version of the IFU free of charge and within a certain timeframe.

Specific devices that should be provided with an eIFU

There were mixed responses on specific types of medical devices that should be provided with an eIFU. Some suggested that the option for eIFU should be encouraged with all medical devices whereas others suggested that manufacturers should be allowed to determine if an eIFU is appropriate for their product based on factors such as intended users, risk and benefit analysis and probability of device misuse.

There are certain situations where a paper version may be more beneficial over an electronic version including emergency situations (e.g., pacemakers), accessibility issues for vulnerable populations (e.g. elderly), remote or low-resource settings (e.g. war zones), high safety risks, and unreliable technological environments (e.g. inconsistent internet/cellular communication or electricity service). Traditional printed IFUs remain a critical safety component for these scenarios, ensuring users can access information without relying on technology.

Availability of eIFU

Most respondents suggested that the eIFU should be made available until a few years after the expected lifecycle of the product as consumers tend to use a medical device even after the expiry date. There were other suggestions that the duration should be determined based on a number of factors such as type of the device, patient safety, intended user (health professional or consumer), number of updates made, the impact of change to end users, device complexity and manufacturing policies.

Accessibility and storage of eIFU

Most respondents suggested the eIFU to be made available through a manufacturer’s website and consumers be provided with a searchable link or QR code on packaging to access it without having to register or sign-up to their website. There should also be an option to download the eIFU in common and searchable formats like Word or PDF for the purposes of printing.

Most medical device consumers and health professionals stated that they will prefer the TGA website or the Australian UDI database to be the central source for accessing eIFU.

Manufacturers’ requirements for supply of eIFU

Most respondents agreed with the proposed manufacturer’s requirements by the TGA for supply of eIFU with additional suggestions such as multilingual support, accessibility support for disabled users, establishing a process for revision control, notification to all users if information is updated, and removing unnecessary sign-in and password protection to access manufacturer’s website. Those who disagreed had concerns about the need to maintain eIFUs on both the manufacturer’s website and the UDI database.

We have reviewed the feedback received for this consultation. All feedback on the proposals will be provided to the Minister and the Government for their consideration. We will inform stakeholders on the outcomes of the Government’s consideration, including any approval to  progress adopting changes to the requirements for IFUs.

We asked: 

From 22 May 2024 to 23 April 2024, we sought submissions from the public on scheduling proposals referred to the June 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

You said: 

We received a total of 8 submissions in response to the pre-meeting public notice for June 2024. The breakdown of the responses has been provided below: 

SILDENAFIL: A total of 4 votes were received for sildenafil, one in full support, one in partial support and 2 in opposition of the proposal. All submissions provided a written response.

ALLYL ESTERS: No votes were received for allyl esters.

GLYOXYLIC ACID: No votes were received for glyoxylic acid.

INTRAVENOUS POTASSIUM SALTS: A total of 3 votes were received for intravenous potassium salts, all in full support of the proposal. Of these submissions, 2 provided a written response.

SULFONAMIDES: A total of 1 vote was received for sulfonamides, which was in full support the proposal. The submission did not provide a written response.

We did: 

The Delegate considered all submissions prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 19 September 2024. 

From 3 April 2024 to 17 April 2024, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the November 2023 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written submission.

A total of 32 submissions were received through the consultation, 21 from individuals and 11 from organisations. A breakdown of the submissions can be found below.

ASTODRIMER SODIUM: 11 submissions were received, 10 in full support, and 1 in partial support of the interim decision. Of these, 10 provided a written component, 9 written submissions in support, and 1 in partial support.  

BILASTINE: 1 submission was received, which was in full support of the interim decision. No written component was included.

BPC-157: 1 submission was received, which was in full support of the interim decision. No written component was included.

GLYCOPYRRONIUM: 2 submissions were received, which were in opposition of the interim decision. All submissions included a written component.  

METHENAMINE: 4 submissions were received, 1 in full support, 2 in partial support, and 1 in opposition of the interim decision. Of these, 3 provided a written submission, 2 were in partial support and 1 was in opposition of the interim decision.  

NARATRIPTAN: 1 submission was received, which was in full support of the interim decision. No written component was included.  

PARACETAMOL: 6 submissions were received, 2 in full support, 1 in partial support, and 3 in opposition of the interim decision. Of these, 3 provided a written submission, 1 in support, 1 in partial support and 1 in opposition of the interim decision.  

ANIMAL BLOOD PRODUCTS: 1 submission which included a written component was received, the submission was in support of the interim decision.

BILE ACIDS: 1 submission which included a written component was received, the submission was in opposition of the interim decision.

ADRENALINE: 2 submissions were received, which were in full support of the interim decision. No written component was included.

BENZOIC ACID: 2 submissions were received, which were in full support of the interim decision. Of these, 1 submission included a written component.

MELOXICAM: 11 submissions were received, which were all in full support of the interim decision. Of these, 5 provided a written component.

PALMITOYLETHENOLAMIDE (PEA): 2 submissions were received, which were both in support of the interim decision. All submissions included a written component.

CAMPROMORELIN: No submissions were received.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard were published on 22 May 2024.

We asked for feedback on two draft guidance web pages we developed to support the changes to TGA oversight of clinical trials of medical devices. The pages describe the review process for first-in-human high-risk implantable or cardiac invasive medical device clinical trials and the expectations for Investigator’s brochures for medical device clinical trials.

We received two submissions, with respondents suggesting some minor points of clarification. 

We thank respondents for providing their feedback, which has been reviewed and incorporated into the draft guidance. The guidance will soon be published on the TGA website.

The supply of medicines can be interrupted for various reasons, causing significant impact on the health and wellbeing of Australians.

At the Therapeutic Goods Administration (TGA), we have improved how medicine shortages and discontinuations are managed in many ways. But we want to do more to further reduce the impact for Australians.

We wanted to hear from people who are impacted by medicine shortages and discontinuations including individual consumers and health professionals, consumer and health professional organisations, the pharmaceutical industry and state and territory health departments.

We asked them:

• How do medicine shortages and discontinuations impact you?
• What challenges and barriers do you face when you’re planning for and responding to medicine shortages and discontinuations?
• How do you ask for, receive and communicate information about the availability of medicines? What are the challenges and barriers you face doing this?
• What do you think the TGA, you, and others could do to improve the situation? How can we collaborate to face the challenges and barriers to a reliable supply of medicines in Australia?

We are using the feedback we received to make recommendations for improvements to further reduce the impact of medicine shortages and discontinuations on Australians.

We received 221 submissions in response to the consultation. These came from:

• state and territory health departments
• health professional representative bodies
• pharmaceutical industry representatives
• consumer representative groups
• individual healthcare professionals
• individual consumers.

These submissions provided a range of experiences and views on medicine shortage impacts, challenges and improvement opportunities.

Stakeholders also raised concerns on the vulnerability of Australia’s medicine supply chain and Australia’s reliance on overseas manufacturing of medicines.

Impacts of medicine shortages and discontinuations

A significant number of respondents from all stakeholder groups outlined the considerable time and resources it took for them to monitor and address medicine shortages and discontinuations.

Although the specific activities involved were different depending on the respondent’s situation, the sustained effort required to manage shortages was reported consistently. Respondents also reported the significant impact of this effort on their health, finances and workloads, whether they were consumers, health professionals or were involved in the industry.

Another reported impact of medicine shortages and discontinuations was the increased strain on the public health system when community-based patients go to hospitals in search of their medicine.

Several respondents also highlighted that medicine shortages and discontinuations disproportionately impact certain population groups, including First Nations people and people living in rural and remote areas of Australia.

Medicine shortages most frequently mentioned 

We asked all respondents to list medicine shortages that have impacted them over the past 12 months. The medicine shortages most frequently mentioned were:

• lisdexamfetamine capsules
• semaglutide injections
• menopause hormone therapy patches
• opioid oral liquid (discontinuations)
• antibiotic medicines
• combination blood pressure and cholesterol-lowering medicines

Opportunities for improvement

Most respondents expressed a desire for improved access to and content of medicine shortages information. They wanted:

• to receive notifications about shortages and discontinuations sooner
• notifications about shortages and discontinuations to be tailored to their interests and needs
• greater transparency about the reasons for a medicine shortage
• consistent and location-specific information about stock availability
• more accurate return-to-supply dates.

There was general support for earlier coordination, engagement and collaboration between the TGA, the pharmaceutical industry and key stakeholders when a medicine shortage is predicted.

Some respondents indicated that current regulatory processes were impacting their capacity to effectively manage or respond to medicine shortages. They wanted prescribing, dispensing and manufacturing regulations to be more flexible and easier to comply with.

Other matters relating to the supply of medicines in Australia

We also received a number of submissions from individual consumers and health professionals advocating for the registration of specific COVID-19 vaccines and treatments. This issue was beyond the scope of the consultation.

The TGA analysed all submissions to the public consultation and compared the feedback with the findings from our recent market research survey, which ran from 23 February 2024 to 13 March 2024.

This market research consisted of an online survey (800 participants) and 17 one-on-one interviews. The participants were individual consumers, pharmacists and prescribers. They were asked about the clinical, economic and lifestyle impacts of medicine shortages and discontinuations. All participants were reimbursed for their time.

Market research - Understanding the impact of medicine shortages in Australia.

Summary of challenges and barriers

We summarised the public consultation and market research feedback about the challenges and barriers of medicine shortages and discontinuations, under 6 themes:

1. Information can be inconsistent, inaccurate, come too late, or be out of date

• When a health professional prescribes a medicine, they often won’t know if it is available or in short supply,  or where to find information about alternatives, especially if a medicine has been discontinued.
• Consumers and pharmacists feel they receive varied and out-of-date information about the availability of medicines during shortages.
• Pharmaceutical companies (sponsors) don't find out about a competitor's product shortage in time to manage the possible increased demand for their product.

2. Sponsors don’t have to report shortages of all important medicines

• The TGA introduced a mandatory reporting scheme for medicine shortages and permanent discontinuations of all prescription and some over-the-counter medicines in 2019. However, the requirement for sponsors to report shortages to the TGA does not cover all medicines that are important to the health of consumers in Australia.
• Non-reportable medicines mentioned in the consultation include:
  • radiopharmaceuticals
  • contrast agents (for medical imaging)
  • intravenous saline
  • paediatric analgesic medicines
  • topical scabies treatments.

3. Low confidence or uncertainty in the supply chain can lead to stockpiling behaviour by consumers and pharmacies.

• When consumers and pharmacists are not confident in the reliability of their medicine supply or do not fully understand the reason for a shortage or discontinuation, they can resort to stockpiling to ensure continuity of supply. This makes it difficult for sponsors to predict demand.
• It’s difficult for sponsors to predict how long and severe a medicine shortage will be when the reason is outside of their control, such as fluctuations caused by competitor shortages, excessive stockpiling and changes to what the medicine is being prescribed for.
• Consumers feel there is limited coordination between their healthcare professionals when responding to medicine shortages. They feel they must take on the responsibility of finding solutions which can lead to delays in accessing their medicines and reduced confidence in the medicine supply chain.

4. Consumers with limited treatment options are disproportionately impacted by medicine shortages and discontinuations

• Consumers experience significant impacts when there are few or no suitable alternatives available for a medicine in shortage or discontinued. For example, we heard from several individual healthcare professionals about the impact of the recent colestyramine powder sachet shortage for people using it as a last line therapy for severe diarrhoea following ileal resection. Many people rationed their remaining supply because there were limited alternative treatments available for this condition.
• Consumers who use medicines for rare conditions face greater impacts when those medicines are discontinued as there are often few alternatives on the Australian market. For example, the recent discontinuation of lomustine capsules sparked significant concern from the Australian oncology community because there are very few alternatives available to treat glioblastoma, a rare and aggressive brain cancer.

5. Time-consuming and manual administrative and regulatory processes for accessing alternative medicines cause delays to treatment.

• Consumers face manual and time-consuming steps when attempting to access an alternative medicine, including travelling to multiple pharmacies and making additional appointments. This disproportionally impacts consumers in rural and remote areas who have further to travel to pharmacies and prescribers.
• Sponsors report that many regulatory and administrative requirements for monitoring, reporting and responding to medicine shortages and discontinuations are manual and time-consuming. This diverts attention from actively managing the medicine shortage.
• Some of the TGA’s regulatory processes and systems are perceived to be inefficient and can hinder timely management and communication of medicine shortages and discontinuations.  For example, the process of adding new overseas medicine approvals to the Section 19A Database on the TGA website may take several days, causing delays in making this information accessible to consumers and healthcare professionals.
• Some hospitals and health organisations are investing significant time and resources developing the same guidance and alerts about how to manage individual medicine shortages and discontinuations. This duplication of effort wastes time and resources that could be used more effectively elsewhere.

6. There are inequalities in the distribution of and access to limited stock*

• Some alternative medicines can be more costly. Consumers on lower incomes have reduced access to medicines during a shortage and it can push some consumers into the public hospital setting.
• Consumers with limited health literacy are more at risk of negative clinical outcomes from delays in accessing medicines.
• Pharmacies that can afford to purchase and store extra stock experience lesser impacts of medicine shortages and potentially limit access to stock for other pharmacies.

*Please note, issues mentioned within challenge theme 6 fall outside the TGA’s regulatory jurisdiction. However, we recognise these challenges have a considerable impact on consumers and health professionals and will be directed to the relevant areas of the Department.

Recommendations for reforms 

Medicine supply chains are complex global systems involving many parties. In June 2024, we hosted a webinar to present the consultation and market research findings to stakeholders in the medicine supply chain including representatives from the pharmaceutical industry, health professional and consumer organisations and state and territory health departments.

These stakeholders also participated in a series of online focus groups to discuss and prioritise issues identified in the consultation and market research, focusing on addressing the most critical and practical issues first.

Outcomes of these discussions, including recommendations on priority areas for potential reform, were provided to the Australian Government for consideration. On 6 November 2024, the TGA announced proposed improvements to TGA’s monitoring and management of medicine shortages and discontinuations.  

We asked for feedback on whether or not certain international scientific guidelines should be adopted by the Therapeutic Goods Administration (TGA).

There were 13 international scientific guidelines being considered in this consultation, as follows:

1. ICH M9 guideline on biopharmaceutics classification system-based biowaivers Step 5
2. Nonclinical safety testing in support of development of paediatric pharmaceuticals S11
3. ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population Step 5 - Addendum
4. ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
5. Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
6. ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.5
7. Guideline on the evaluation of anticancer medicinal products in man
8. ICH guideline E8 (R1) on general considerations for clinical studies Step 5
9. ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
10. ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk Step 5
11. ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes Step 5
12. ICH guideline M10 on bioanalytical method validation and study sample analysis Step5
13. ICH guideline Q3D (R2) on elemental impurities Step 5

While international scientific 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. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified.

We received 17 submissions in response to the consultation, including from consumer and industry organisations, government, and from individual consumers.

There was broad support for adopting the 13 guidelines outlined above. Submitted responses, where consent was given to publish, can be found under the ‘Published responses’ section.

Following an extensive process of internal and external consultation to ensure each international scientific guideline is consistent with prevailing requirements in Australia, the TGA has adopted the 13 international scientific guidelines considered in this consultation.

One guideline, the ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.5, required TGA annotation as follows:

• Please refer to the TGA’s webpage TGA Implementation of ICH eCTD v4.0 Specification regarding the TGA’s implementation plan for this guideline.

From 5 January 2024 to 5 February 2024, we sought submissions from the public on scheduling proposals referred to the March 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents could indicate their support or opposition to the proposed amendments with or without a written response.

We received 124 submissions in response to the pre-meeting public notice for March 2024. The breakdown of the responses is provided below:

For cytisine, a total of 41 responses were received, 3 in opposition, 2 in partial support and 36 in full support of the proposed interim decision.

For dextromethorphan, a total of 14 responses were received, 5 in opposition, 2 in partial support and 7 in full support of the proposed interim decision.

For dihydocoodeine, a total of 12 responses were received, 4 in opposition, and 8 in full support of the proposed interim decision.

For ethylmorphine, a total of 10 responses were received, 2 in opposition, 2 in partial support and 6 in full support of the proposed interim decision.

For ethyl lactyl retinoate, a total of 9 responses were received, 2 in opposition, 1 in partial support and 6 in full support of the proposed interim decision.

For niclosamide, a total of 6 responses were received, 1 in partial support and 5 in full support of the proposed interim decision.

For oxytetracycline, a total of 23 responses were received, 19 in opposition, and 4 in full support of the proposed interim decision.

For tranexamic acid, a total of 9 responses were received, 2 in opposition, and 7 in full support of the proposed interim decision.

The Delegate considered all responses prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 26 July 2024.

Between 8 December 2023 and 31 January 2024, we undertook a public consultation to seek feedback on the appropriateness of the proposed requirements in the draft quality standards for MDMA and psilocybin.

We received 25 submissions from sponsors, manufacturers, pharmacists, health-care practitioners, industry associations, patients and members of the public.

There was broad in-principle support for the proposed quality standards for MDMA and psilocybin, however a number of suggestions for minor technical changes were recommended:

• Changes to the assay limits for active pharmaceutical ingredients (API) and finish product for both MDMA and psilocybin.
• Changes to the testing limits for impurities, heavy metals, and residual solvents.
• Employing United States Pharmacopeia (USP) or International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines as an alternative to European Pharmacopoeia methods and limits.
• Including additional testing, such as loss on ignition, appearance and content uniformity.
• Including a transition period to allow sufficient time to develop and validate methods for testing the APIs and finished products.

All submissions that gave permission to be published on our website are available through the ‘View submitted responses’ link below.

We appreciate all the feedback and thank all respondents for their submissions.

We have considered all of the submissions, and in response, some minor amendments will be made to the draft standards for MDMA and psilocybin.

A summary of the responses, the rationale for our decisions and the proposed changes are outlined in the Proposed quality standards for MDMA and Psilocybin – Consultation outcomes paper.

The quality standards will be registered as Therapeutic Goods Orders (TGO) on the Federal Register of Legislation in mid-2024 and will have a commencement date of 6 January 2025 to allow industry time to develop and validate test methods.  

Between 5 October 2023 to 2 November 2023, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the June 2023 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

A total of 9 submissions were received through the consultation, 1 from an individual and 8 from organisations. A breakdown of the submissions can be found below.

Bisacodyl: 2 submissions were received for bisacodyl, both supportive of the interim decision. Both submissions contained a written component in support.

Olopatadine: 2 submissions were received, both partially supportive of the interim decision. Both submissions included a written component.

Ibotenic acid: 3 submissions were received, with 1 in support of the interim decision and 2 in partial support. All submissions included a written component.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard (except for amygdalin and hydrocyanic acid) were published on 15 December 2023.

From 1 September 2023 to 29 September 2023, we sought submissions from the public on scheduling proposals referred to the November 2023 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response. 

We received 237 submissions in response to the pre-meeting public notice for November 2023. The breakdown of the responses is provided below:  

ASTODRIMER SODIUM: 167 responses were received for ASTODRIMER SODIUM 166 in full support, and 1 in partial support of the proposal. Of these, 137 provided a written response, 136 written responses in support, and 1 written response in partial support.  

BILASTINE: 25 responses were received, 24 in full support, and 1 in partial support of the proposal. Of these, 5 provided a written response, all were in support of the proposal.  

BPC-157: 22 responses were received, 21 in full support, and 1 in partial support of the proposal. Of these, 4 provided a written response, all were in support of the proposal.  

GLYCOPYRRONIUM: 28 responses were received, 26 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 7 provided a written response, 5 written responses in support, 1 written response in partial support and 1 in opposition.  

METHENAMINE: 25 responses were received, 24 in full support, and 1 in partial support of the proposal. Of these, 5 provided a written response, all were in support of the proposal.  

NARATRIPTAN: 26 responses were received, 24 in full support, and 2 in partial support of the proposal. Of these, 4 provided a written response, 3 written responses in support, and 1 written response in partial support.  

PARACETAMOL: 45 responses were received, 34 in full support, and 11 in opposition of the proposal. Of these, 16 provided a written response, 8 written responses in support, and 8 in opposition.  

ANIMAL BLOOD PRODUCTS: 20 responses were received, 18 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 6 provided a written response, 5 written responses in support, and 1 written response in partial support.  

BILE ACIDS: 17 responses were received, 16 in full support, and 1 in opposition of the proposal. Of these, 2 provided a written response, all were in support of the proposal.  

ADRENALINE: A total of 23 responses were received, 22 in full support, and 1 in opposition of the proposal. Of these, 5 provided a written response, all were in support of the proposal.  

BENZOIC ACID: 21 responses were received, 18 in full support, and 3 in opposition of the proposal. Of these, 5 provided a written response, 2 written responses in support, and 3 in opposition.  

MELOXICAM: 82 responses were received, 79 in full support, 1 in partial support and 2 in opposition of the proposal. Of these, 60 provided a written response, 57 written responses in support, 1 written response in partial support and 2 in opposition.  

PALMITOYLETHENOLAMIDE (PEA): A total of 19 responses were received, 17 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 3 provided a written response, 1 written response in support, 1 written response in partial support and 1 in opposition.  

The Delegate considered all responses prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 3 APRIL 2024

The TGA sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes were intended to address the following issues:

1. Curcuma species and curcumin and the risk of liver injury
2. Green tea extract and the risk of liver injury
3. Safe levels of benzophenone
4. Clarification of the requirements for soy phosphatidylserine-enriched ingredients
5. Clarification of the requirements for Terminalia ferdinandiana

A total of 27 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

• 10 responses to the proposed liver warning statement for Curcuma species and curcumin
• 7 responses to the proposed liver injury warning statement for Camellia sinensis
• 16 responses to the proposed safety limit on benzophenone
• 4 responses to the proposed update to the requirements for soy-phosphatidylserine enriched ingredients
• 3 responses to the proposed update to the requirements for Terminalia ferdinandiana

The responses varied in stance and recommendations, however, the majority of respondents from the complementary medicines industry did not support or only partially supported the proposals, with many suggesting rewording or clarification of the proposed warning statements and requirements. See the Final Decisions document for details of issues raised by respondents and the TGA’s response.

The feedback and recommendations provided by respondents were taken into consideration in making the final decisions to amend the Permissible Ingredients Determination for the ingredients discussed in the consultation. The final changes incorporate variation compared to the original proposals.

The final changes will commence on 1 March 2024. A 12-month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2025.

We invited feedback on a proposed risk-based application audit framework for medical devices, including In Vitro Diagnostic (IVD) medical devices. The framework described how we proposed to select medical device applications for audit and conduct those audits.

The key elements of the proposed application audit framework included:

• risk factors informing non-mandatory audit selection,
• criteria for mandatory audits,
• the evidence to be provided with applications to inform audit selection,
• limiting the number of substantial assessment rounds,
• mechanisms to improve visibility of application audit timeframes
• cost recovery measures for non-mandatory audits, and
• pathways for Class III devices with Medical Device Single Audit Program (MDSAP) certification and US FDA 510(k) approval.

We received twenty-six (26) submissions.

The overall level for the proposed new risk-based application audit framework was positive with broad support for:

• limiting mandatory audits to Class III, Class 4 IVD, Class 3 IVD, point-of-care and self-test IVD medical devices
• exempting medical devices with recognised comparable overseas regulator approvals from mandatory audit
• establishing a new mandatory audit pathway for Class III medical devices with MDSAP and US FDA 510 (k) approval
• repealing clause 5.3(1)(j)(viii) in the Regulations, relevant to IVD medical devices, because it is ambiguous and non-transparent in its operation.

Most respondents supported the proposal for the TGA to publish risk factors that influence non-mandatory audit selection, but they wanted more clarity about the rationale for the proposed risk factors and how each risk factor would be weighted and combined to influence the audit selection decision.

Most respondents expressed concerns about:

• requiring applicants to submit the Instructions for Use and the Clinical Evaluation Report for Class III devices with European Medical Device Regulation certification
• limiting audits to two substantial rounds of review.

Most respondents suggested improvements to the application audit process, including improved communication, transparency, and timeframes. Respondents said we should not delay improvements while we deliver the TGA digital transformation project.

The consultation responses supported the proposed changes to the criteria for mandatory audits and the proposed MDSAP and US FDA 510(k) pathway. The TGA is seeking Government approval to amend the legislation accordingly.

Next Steps

The TGA is also using the feedback from the consultation to:

• develop detailed guidance on the risk factors we will consider when selecting applications for audit. Once the guidance is published, we will review the risk factors periodically
• do further work to review the evidence we require to be provided with applications to inform audit selection. We will review the requirement for applicants to provide clinical evidence for all class III medical device applications with comparable overseas regulator approval
• improve the way we communicate with applicants about these audits
• improve assessment timeframes for these audits, including considering establishing target timeframes.

Between 13 July 2023 to 10 August 2023, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the March 2023 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

A total of 6 submissions were received through the consultation, 1 from an individual and 5 from organisations. A breakdown of the submissions can be found below.

Celecoxib: 2 submissions were received for celecoxib, both supportive of the interim decision. Both submissions contained a written component in support.

Azelaic acid: 4 submissions were received, all in support of the interim decision. All 4 of the submissions provided a written component in support of the interim decision.

Bromoxynil: 1 submission was received in support of the interim decision which contained a written component.

Dioxane: 3 submissions were received, 2 in support and 1 in partial support of the interim decision.  All 3 responses contained a written component, 2 in support and 1 in partial support.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard were published on 4 September 2023.

We asked for feedback on potential changes to the regulatory requirements for non-IVD medical devices that contain tissues, cells, or substances of animal, microbial or recombinant origin.

We sought feedback on:

1. the risk of certain materials of animal, microbial or recombinant origin
2. removing microbial or recombinant tissues, cells, or other substances from classification rule 5.5, Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
3. accepting evidence from a broader range of comparable overseas regulators for devices that contain substances of animal, microbial or recombinant origin.

We received twenty responses.

Most respondents agreed with excluding certain low-risk animal origin materials from classification rule 5.5 and removing “microbial or recombinant origin substances” in general. They commented that these substances are low risk, and the change would align more closely with international regulatory frameworks. Some respondents pointed out that the Essential Principles of the Regulations already specify the safety requirements for the control of animal, microbial or recombinant origin substances.

There was strong support for accepting conformity assessment evidence from a broader range of comparable overseas regulators. Respondents reported that the current requirements are burdensome and have delayed supply of some devices to Australia despite having approvals from recognized comparable overseas regulators. All respondents stated these changes would reduce regulatory burden and enable Australians to have faster access to safe products.

Several respondents asked that the specific labelling requirement related to microbial or recombinant origin substances also be removed from the Regulations to reduce the burden of maintaining Australian-specific Instructions for Use.

The TGA appreciates all the feedback and thanks all respondents.

We analysed the responses and have considered the feedback to shape regulatory reform and policy that is risk-based and that removes unnecessary regulatory burden.

In December 2023, the Government agreed to

a) remove “microbial or recombinant origin substances” from classification rule 5.5 (clause 5.5, Part 5, Schedule 2 of the Regulations)

b) remove associated labelling requirements under Essential Principle 13.4

c) exclude other certain low-risk animal origin materials from classification rule 5.5

d) provide a two-year transition for existing approved devices

e) accept a broader range of comparable overseas regulators for these devices.

We are preparing regulatory amendments for Government approval for possible commencement in mid-2024.