Boundary and combination products guidance - medicines, medical devices, and biologicals

We asked your feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’ which will replace the existing guidance ‘Australian medical devices guidelines: 35. Device-medicine boundary products’.

The guidance aims to assist sponsors and manufacturers understand how TGA regulates boundary and combination products that may not fit clearly within existing definition of medicines, medical devices or biologicals.

Thirty-one (31) responses were received from stakeholders, including sponsors, manufacturers, industry peak bodies, regulatory affairs consultants, transplant donation organisations, contract research companies and other health regulators.

Alignment of guidance with respondent’s understanding

Overall, a majority of respondents (55%, n=17) indicated that the draft guidance material aligns with their current understanding of medicines, medical devices, and biologicals.

Out of those respondents who disagreed (45%, n=14) on the alignment with their current understanding, most suggested examples that were not addressed in the draft guidance, and that there were products listed in Appendix 1 where:

• further clarification of the product, category or mode of action is needed,
• the rationale for the product category designation was not clear, or counter-intuitive, and
• the product category is not in alignment with international jurisdictions.

Products that are not in alignment with the definitions

Some respondents (24%, n=13) indicated that there were products on the market that were not aligned with the definition and product category mentioned in the draft guidance for example:

• products for lice on the head and body
• products for removal of warts
• corn and callus removal products
• oral care toothpastes
• products used to cleanse dentures
• throat lozenges
• sunscreens that work through creating a physical barrier (zinc oxide-based)
• compounded and uncompounded emollient & moisturising preparations for therapeutic use
• anticoagulation solution bags used during blood cell separation (apheresis)
• carbon crucible required to make Technegas
• alcohol swabs containing an active ingredient or medicine claiming use for cleaning skin only
• non-antibiotic-based antimicrobial catheter lock solutions sold separately from a catheter
• personal lubricants used during sexual activity
• douches (e.g., douche applicator, solution, applicator-solution combined)

Interim arrangements for change of product category

Out of those who responded (n=29) to the question, majority (67%, n=12) suggested that special, interim arrangements would be required to ensure continued supply of products if the product category was changed whereas, six respondents (33%) suggested interim arrangements would not be required. Remaining stated that the question is not applicable to them.

In general, respondents advised that the timing of interim arrangements would depend on requirements from the TGA.

Respondents raised several issues and challenges regarding transitioning of products to new categories including:

• manufacturers may not be able to provide the required regulatory evidence to support product inclusion under a new category,
• transitioning products supplied as a medical device to a medicine will be difficult, as these products will now need to be manufactured according to GMP requirements, and
• potential costs for industry might result in business decision to withdraw products from the Australian market.

There were several other suggestions provided by respondents to improve the draft guidance across the range of submissions. These included:

• harmonising with international definitions for pharmacologic, physical and metabolic means
• use of decision trees or tools to help sponsors decide product categories
• adding guidance on regulatory evidence required for combination products
• adding more:
  • information on boundaries between medicines, food and cosmetics, 
  • information explaining how TGA regulates and categorises boundary and combination products and the rationale for regulatory decisions,
  • information on regulation of biologicals and biological combination products,
  • information on excluded goods, kits that contains medicines and biologicals,
  • adding links to TGA guidance on reclassification of medical devices, and
  • examples of each of the categories.

There were suggestions to improve the list of boundary products indicating product categories in Appendix 1 of the draft guidance. These included:

• suggested changes to the list, clarifying or adding products and their categories,
• adding an additional column to the list that explains the rationale for why products are categorised as a medicine, medical device, biological or another product category,
• harmonisation with international jurisdictions where appropriate, with any differences clearly communicated,
• advising sponsors if there is any action required to accommodate the updated guidance,
• clarifying boundary and combination products by making greater use of powers under the Therapeutic Goods Act 1989 (the Act) to specify particular goods to be medical devices and to declare that a particular class of goods to not be medical devices.

In response to your feedback, we revised and published updated guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’ with several changes including:

• more information and examples on regulation of boundary and combination products,
• explanation on how TGA regulates and categorises boundary and combination products,
• links to additional TGA guidance that may help you decide your product category,
• TGA contacts for sponsors and manufacturers who are unsure about the category and regulation of their boundary and combination products,
• improving readability by moving detailed background information on the definitions of medicine, medical device and biologicals and differentiating terms to the end of the document into an Appendix.

The example list of boundary and combination products indicating the category of therapeutic good has also been updated and published on the TGA website. 

What is next

We are undertaking another external consultation on some of the boundary and combination products and considering whether the updated list (formerly Appendix 1) is sufficient to provide regulatory certainty, or if legislative changes would be required.

If legislative changes are proposed, the TGA will consult with stakeholders and consider transitional arrangements for potentially impacted stakeholders. We will continue to engage with you around any further changes.