Consultation: Legislating regulatory categories for some boundary and combination products

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.